MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-30 for RECOVERY CONE REMOVAL SYSTEM manufactured by Bard Peripheral Vascular, Inc.
[76141608]
Patient Sequence No: 1, Text Type: N, H10
[76141609]
The patient had an inferior vena cava (ivc) filter placed at an outside hospital several months ago. He was referred for filter retrieval. The ivc filter was retrieved without trouble. However, a little band or ring placed on the tip of the catheter used to retrieve the sheath broke off and embolized to a small, distal branch of a pulmonary artery. This ring is placed on the catheter to make it visible on fluoroscopy/x-ray during the procedure. The procedural team attempted to retrieve it but could not easily do so and elected to stop. This is a small metal ring (3 mm diameter) in a small distal branch without clinical consequences at present. Manufacturer response for recovery cone removal system, recovery cone removal system (per site reporter): no response at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6597390 |
| MDR Report Key | 6597390 |
| Date Received | 2017-05-30 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-05-18 |
| Report Date | 2017-05-25 |
| Date Reported to FDA | 2017-05-25 |
| Date Reported to Mfgr | 2017-05-25 |
| Date Added to Maude | 2017-05-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | RECOVERY CONE REMOVAL SYSTEM |
| Generic Name | VENA CAVA FILTER REMOVER |
| Product Code | MMX |
| Date Received | 2017-05-30 |
| Returned To Mfg | 2017-05-19 |
| Lot Number | GFBN3372 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC |
| Manufacturer Address | 1625 WEST 3RD STREET TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-30 |