MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for BARD CROSSER CTO RECANALIZATION CATHETER CRUS6A manufactured by Bard Peripheral Vascular, Inc..
[177966204]
A 4mm tip of cto recanalization catheter ultrasound tip sheared off and became imbedded in calcified plaque in occluded left iliac artery. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092746 |
| MDR Report Key | 9671202 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD CROSSER CTO RECANALIZATION CATHETER |
| Generic Name | CATHETER FOR CROSSING TOTAL OCCLUSIONS |
| Product Code | PDU |
| Date Received | 2020-02-04 |
| Catalog Number | CRUS6A |
| Lot Number | GFDV0756 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |