MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-05-17 for BARD SNARE RETRIEVAL KIT SRK35 manufactured by Heraeus Medical Components, Llc.
[108618030]
The device has not been returned, therefore no device evaluation could be performed. Review of manufacturing and sterilization records could not be performed because the product lot number was not provided. Heraeus is unable to comment on the condition of the device or the cause of the occurence. If additional relevant information is received, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[108618051]
It was reported that the surgeon was not able to get the snare to engage at the hook of the filter. He was able to snare the filter around the body of the filter, but could not get it out through the sheath. He elected to perform, in his words "a little cut down" and retrieved the filter successfully. (b)(6) asked him if he felt there was an issue or problem with the snare when he used it this second time. He said no. The surgeon reported a fibrotic clot around the hook of the filter and retrieving it by open approach had caused the filter leg to bend. There was no harm to the patient. Review of the event description listed in the cir stated: the health care providere initially attempted to remove the patient's dl950f filter with an srk 35 on (b)(6) 2018 at (b)(6) hospital, (b)(6). This attempt was unsuccessful, and the snare loop would not engage around the hook, enabling successful snaring of the filter. In a post operative conversation, it was agreed that it was highly likely that there was a large clot at the hook of the filter, which was undetectable by fluoroscopy, and thus prevented the snare loop from capturing the filter at the hook. The filter was inserted approximately 6 months prior, as she was about to undergo major abdominal surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135342-2018-00003 |
| MDR Report Key | 7524181 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-05-17 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES LEDAMA |
| Manufacturer Street | 2605 FERNBROOK LANE N SUITE J |
| 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 | VENA CAVA RETRIEVAL DEVICE |
| Product Code | MMX |
| Date Received | 2018-05-17 |
| Catalog Number | SRK35 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS MEDICAL COMPONENTS, LLC |
| Manufacturer Address | 2605 FERNBROOK LANE N SUITE J PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-17 |