MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-05-23 for BARD SNARE RETREIVAL KIT SRK35 manufactured by Heraeus Medical Components, Llc.
[75762854]
The device was not returned for evaluation. The lot number was not provided. The user facility provided photographic and fluoroscopic images. The distributor completed a review of the images. Two images demonstrated a snare device to have captured and retrieved the filter inside the retrieval sheath; however, the image demonstrated the distal filter legs remained outside the sheath. Based on the images provided it is unknown if the entire filter was retrieved inside the retrieval sheath prior to removal. The last two images demonstrated the filter was no longer inside the deployment sheath; the filter apex was located just superior to the 1st rib and extending down to the 3rd rib, next to the cervical-thoracic spine. All of the filters limbs were compressed together. The distal marker band of the retrieval sheath was demonstrated superior to the filter, there was no connection between the filter and the retrieval sheath. It is unknown if the filter apex was extending out of the patient's skin. One photo provided demonstrated approximately half of the filter was exposed outside the patient at the access site. Per information received from the clinical specialist, it is likely that tension was released from the snare causing the snare to remove from the filter hook and, upon removing the sheath from the patient, the filter legs caught on the jugular incision. Per discussion and analysis of the images, there was no failure observed from the snare. No information was provided regarding patient outcome. This event occurred in (b)(6). Due to local privacy laws, we were unable to obtain patient information. If additional information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[75762855]
It was reported that approximately three months post femoral deployment of a vena cava filter, a snare device was applied to the filter and closed and drawn into the sheath successfully. Upon retrieval of the inner and outer sheath, the filter dislodged and remained at the jugular incision. The patient was transferred to the or for surgical intervention to remove the filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135342-2017-00001 |
| MDR Report Key | 6584828 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-05-23 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-04-21 |
| Date Added to Maude | 2017-05-23 |
| 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 N, STE 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 RETREIVAL KIT |
| Generic Name | SNARE |
| Product Code | MMX |
| Date Received | 2017-05-23 |
| Model Number | SRK35 |
| Catalog Number | SRK35 |
| Lot Number | NA |
| 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 NORTH, SUI PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-23 |