MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-03-28 for RECOVERY CONE RETRIEVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[2573647]
It was reported during a scheduled retrieval of an ivc filter, the marker band on the recovery cone retrieval system detached and moved to the pt's heart. The access site was predilated with 10f and 11f sheaths. The filter was removed without incident. The marker band was identified in the analysis of the tricuspid valve. The pt was then transferred to another facility. Once transferred to the other facility, additional imaging identified the marker in the distal right pulmonary artery. The retrieval attempt proved unsuccessful. The pt is asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
[9724162]
The lot number has been provided. The device history records were reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the quality control testing. This lot met all release criteria. There is nothing seen in the dhr to indicate that there was a manufacturing related cause for this event. The sample has been returned to the manufacturer for evaluation. The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2012-00075 |
| MDR Report Key | 2512774 |
| Report Source | 07 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-06 |
| Date of Event | 2012-03-06 |
| Date Mfgr Received | 2012-03-06 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2012-09-06 |
| 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 | ERIC STEMMLER |
| 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 RETRIEVAL SYSTEM |
| Product Code | GAE |
| Date Received | 2012-03-28 |
| Returned To Mfg | 2012-03-16 |
| Catalog Number | RC15 |
| Lot Number | GFTK3548 |
| Device Expiration Date | 2012-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-03-28 |