MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-25 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[3990749]
It was reported that after successful retrieval of the vena cava filter with the recovery cone, a marker band detached from the removal system introducer sheath. During a retrieval attempt with forceps, the marker band slipped from the forceps and migrated to the pulmonary artery. The marker band was successfully retrieved percutaneously from the pulmonary artery at a later date. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[11688200]
The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for corporate lot number gfxa3806. The device was returned images were provided. Based upon the sample evaluation and the image review, the complaint investigation is confirmed for a marker band detachment. It should be noted that per the reported event details and the condition of the returned sample, the recovery cone was used to retrieve a bpv denali filter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2013-00381 |
| MDR Report Key | 3636094 |
| Report Source | 05,06 |
| Date Received | 2013-11-25 |
| Date of Report | 2013-10-01 |
| Date of Event | 2012-10-27 |
| Date Mfgr Received | 2013-11-13 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-03-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRYAN VOGEL |
| Manufacturer Street | 1625 WEST 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4808949515 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804204 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 2045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECOVERY CONE REMOVAL SYSTEM |
| Product Code | GAE |
| Date Received | 2013-11-25 |
| Returned To Mfg | 2013-10-17 |
| Catalog Number | RC15 |
| Lot Number | GFXA3806 |
| Device Expiration Date | 2016-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | TEMPE AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-25 |