MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-20 for BARD SNARE RETRIEVAL KIT SRK35 manufactured by Heraeus Medical Components, Llc.
[90661072]
The device has not been returned, therefore no device evaluation could be performed. Review of manufacturing and sterilization records showed the device met specifications. Per discussion with the clinical specialist, the snare properly captured the filter retrieval hook and maintained control of the filter. Due to the filter not being entirely pulled into the retrieval sheath, one of the caudal anchors remained outside the sheath and became lodged in the tissue surrounding the jugular access site. The ifu states, " once the filter is fully collapsed inside the retrieval sheath, retract the filter, snare, and retrieval sheath as one unit out through the 11f access sheath. " there is no indication that the snare retrieval device malfunctioned. It appears that the directions, as stated in the ifu, were not completely followed. This event occurred in (b)(6). If additional information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[90661073]
It was reported that during a jugular vena cava filter retrieval procedure, allegedly, the filter could not be pulled into the sheath entirely. A caudel anchor was left outside of the sheath and got stuck on a muscle upon removal. A small incision was made to widen the access site, and the filter was retrieved successfully. There was no patient consequence or impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135342-2017-00005 |
| MDR Report Key | 6964903 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-20 |
| Date of Report | 2017-09-21 |
| Date of Event | 2007-08-01 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2017-10-20 |
| 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 | MARGARET BATCHELDER |
| Manufacturer Street | 2605 FERNBROOK LANE NORTH, SUI |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD SNARE RETRIEVAL KIT |
| Generic Name | SNARE |
| Product Code | MMX |
| Date Received | 2017-10-20 |
| Model Number | SRK35 |
| Catalog Number | SRK35 |
| Lot Number | MO44458 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS MEDICAL COMPONENTS, LLC |
| Manufacturer Address | 2605 FERNBROOK LANE NORTH, SUI PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |