MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-02-01 for CARDIO THORACIC UNKNOWN UNKNOWN CARDIO THORACIC manufactured by Covidien.
[37240653]
Submit date (b)(6) 2016. An investigation is currently under way; upon completion the results will be forwarded. (b)(4). Several attempts to gather information from the customer were made. To date, no additional information has been received. If additional pertinent information becomes available, the report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[37240654]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an artery shunt. The investigator reported there was a patient death while the argyle shunt was in place. This was discovered during a literature review.
Patient Sequence No: 1, Text Type: D, B5
[39105447]
This complaint was discovered during a literature review. The product and lot number involved in this event is unknown. This complaint has not been confirmed. The complaint sample was not returned to the manufacturing site for review. No lot number was provided, therefore, it is not possible to perform a device history record (dhr) review. All dhr? S are reviewed for accuracy prior to a products release. Without the sample or additional information, it is not possible to establish if there is a failure mode related to manufacturing or the device. The source literature for this event was reviewed and the death could not be attributed to the shunt or a shunt complication. A brainstorming session was performed in order to identify the possible causes for the described event. The following potential causes were identified: non device related organ failure, non-device related complications during placement procedure, incorrect catheter size selection, or contaminated catheter. Based on the information in the mentioned literature, no causes could be confirmed to be linked to manufacturing activities or to the device. The complaint sample was not returned to the manufacturing site for review. Should the sample be returned in the future, this complaint will be re-opened for further investigation. Since the lot number was not provided and the sample was not returned, it is not possible to identify the specific products manufacturing date. Based on the reviewed literature related to this complaint, the device functioned as intended during the required time and it concludes shunting should be considered a viable treatment option. Based on the available information, the most probable causes are non-device related organ failure and non-device related complications during placement procedure. Per management discretion, an (b)(4) was initiated to perform a risk assessment linked to this complaint report. No further actions are required at this time. It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling, and environmental and product biological monitoring, are in place to prevent nonconforming product from leaving the manufacturing operations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2016-00058 |
| MDR Report Key | 5402032 |
| Report Source | LITERATURE |
| Date Received | 2016-02-01 |
| Date of Report | 2016-01-11 |
| Date Mfgr Received | 2016-02-25 |
| Date Added to Maude | 2016-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN MANUFACTURING SOLUTIONS |
| Manufacturer Street | EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIO THORACIC UNKNOWN |
| Generic Name | SHUNT |
| Product Code | GYK |
| Date Received | 2016-02-01 |
| Model Number | UNKNOWN CARDIO THORACIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLUTIONS SA EDIFICIO 820 CALLE #2 ZONA FRANCE COYOL ALAJUELA 20101 CS 20101 |
| Brand Name | CARDIO THORACIC UNKNOWN |
| Generic Name | SHUNT |
| Product Code | KDQ |
| Date Received | 2016-02-01 |
| Model Number | UNKNOWN CARDIO THORACIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLUTIONS SA EDIFICIO 820 CALLE #2 ZONA FRANCE COYOL ALAJUELA 20101 CS 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-01 |