MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for CROSSER CTO RECANALIZATION CATHETERS CRE14S manufactured by Bard Peripheral Vascular, Inc..
[178747801]
Of the seven malfunctions, four did not have devices returned and are inconclusive for detachment as no objective evidence has been provided to confirm any alleged deficiency with the device. Two malfunctions have had their devices returned for evaluation and one malfunction is currently awaiting device return. The investigations of the reported malfunctions are currently underway. The devices are labeled for single use. (lot number: gfdt2529, gfdu0364, unknown).
Patient Sequence No: 1, Text Type: N, H10
[178747802]
This report summarizes seven malfunctions. A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced detachment of device. This information was received from various sources. Of the seven detachments, one did not involve a patient, and six involved patients with no consequences. One patient was reported as male and another patient was reported as female with their ages ranging from (b)(6) years-old. All other patient information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00296 |
| MDR Report Key | 9591782 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-04-03 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-01-15 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROSSER CTO RECANALIZATION CATHETERS |
| Generic Name | RECANALIZATION CATHETER |
| Product Code | PDU |
| Date Received | 2020-01-15 |
| Catalog Number | CRE14S |
| Lot Number | GFCT1851,GFDP0655,GFDT3282 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |