MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-07-17 for RECOVERY CONE REMOVAL SYSTEM FBRC manufactured by Bard Peripheral Vascular, Inc..
[16152866]
It was reported that during retrieval of a vena cava filter using a cone removal system, a marker band allegedly detached from the removal system introducer sheath. The health care provider reportedly performed a surgical cutdown to retrieve the marker band. The pt was said to have tolerated the procedure well and was stable postoperatively.
Patient Sequence No: 1, Text Type: D, B5
[16352843]
No device, hospital/medical records or medical images have been made available to the mfr. As the lot number for the device was provided, a review of the device history records is being performed. The investigation of the reported event is underway.
Patient Sequence No: 1, Text Type: N, H10
[61618687]
The device was discarded by the facility, no medical records or no medical images have been made available to the manufacturer. As not lot number for the device was provided, a mfg review was conducted and there was nothing found to indicate there was a mfg related cause for this event. The investigation is inconclusive for the alleged marker band detachment. It should be noted that per the reported event, the recovery cone was used to retrieve a denali filter. The recovery cone is only indicated for use to percutaneously remove the g2 x filter, g2 express filter, g2 filter and the recovery filter from the vena cava, or facilitate the retrieval of foreign objects from the peripheral vascular system. The recovery cone is not indicated for use to remove a denali filter. Therefore, it is likely that user related issues (use of a recovery cone to remove a denali filter) contributed to the alleged marker band detachment. However, the definitive root cause is unk. Note: the sales representative performed an in-servicing with the health care provider on 6/17/2015 on the proper methods and equipment required to successfully retrieve a denali filter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2015-01170 |
| MDR Report Key | 4925811 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-07-17 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-06-17 |
| Date Mfgr Received | 2015-06-17 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-07-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DANA STEGMEIER |
| 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 128042045 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 128042045 |
| 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 | 2015-07-17 |
| Catalog Number | FBRC |
| Lot Number | GFZD3563 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2015-07-17 |