MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-14 for RECOVERY CONE REMOVAL SYSTEM FBRC manufactured by Bard Peripheral Vascular, Inc..
[3326872]
It was reported that after several attempts to retrieve a vena cava filter with a recovery cone, the polyurethane umbrella from the recovery cone was noted to be missing after it was removed from the pt. The detached component could not be located inside or outside of the pt. The pt was reported to be asymptomatic after the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10644345]
The device history records have been reviewed with special attention to the raw materials, the subassemblies, the mfg process and the quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this failure mode. The device and images were not provided. The complaint investigation is inconclusive for polyurethane membrane detachment. It should be noted that this recovery cone was used to retrieve a meridian filter. Per the current meridian ifu (instruction for use), the filter should only be removed using an intravascular snare, not a recovery cone. In addition, the user experienced difficulties capturing the filter with the cone. The meridian filter anchors would be prone to damaging the polyurethane membrane on the cone, therefore, likely causing the membrane to fully detach. As such, based upon the available info, the definitive root cause for this event is likely user related. Recovery cone: the current ifu (instructions for use) states: do not use excessive force when manipulating the cone. Excessive force may damage the catheter or other parts of the recover cone removal system. If resistance is experienced during the retrieval procedure, check the capture filter or foreign body and introducer sheath using fluoroscopy. Meridian filter: the current ifu (instruction for use) states: meridian filter removal. Remove the meridian filter using an intravascular snare and 10 french i. D. Retrieval sheath only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2013-00070 |
| MDR Report Key | 3040612 |
| Report Source | 07 |
| Date Received | 2013-03-14 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-02-26 |
| Date Mfgr Received | 2013-02-26 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-04-16 |
| 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 | 2013-03-14 |
| Catalog Number | FBRC |
| Lot Number | GFWK2449 |
| Device Expiration Date | 2015-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-03-14 |