MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for CROSSER CTO RECANALIZATION CATHETER CRE14S manufactured by Bard Peripheral Vascular, Inc..
[177951481]
A lot number was provided for each of the eight malfunctions, and lot history reviews will be performed. For two of the eight reported malfunctions, the devices have been returned to bd for evaluation, and identified material separation. For five of the eight malfunctions, the devices have not been returned; therefore, the investigations are inconclusive for the material separation as no objective evidence has been provided to confirm any alleged deficiency with the device. For one of the eight malfunctions, the device is pending return. The company is still investigating the issue at this time. Based upon the available information, the definitive root cause is unknown. The company is still investigating the issue at this time. The devices are labeled for single use. (lot number:gfdr2204, gfdt0280, gfcy2780, gfds1793).
Patient Sequence No: 1, Text Type: N, H10
[177951482]
This report summarizes eight malfunctions. A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced material separation. This information was received from various sources. Of the eight malfunctions, seven involved a patient with no known impact to the patient and one did not involve a patient. Of the eight malfunctions, two were male and four were female. One patient was (b)(6) years old weighing (b)(6) kg. The remaining patients? Age, weight, and gender were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00632 |
| MDR Report Key | 9603680 |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-17 |
| 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 CATHETER |
| Generic Name | RECANALIZATION CATHETER |
| Product Code | PDU |
| Date Received | 2020-01-17 |
| Catalog Number | CRE14S |
| Lot Number | GFCY3311, GFDR3204, GFCY3576 |
| Device Availability | * |
| 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 | 2020-01-17 |