MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-18 for EN SNARE EN2007030 manufactured by Merit Medical Ireland Ltd..
[75504190]
The suspect device is not expected to return for evaluation. A review of the device history and complaint database could not be performed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[75504191]
The physician alleges that during a complicated extraction of the a right ventricular pacemaker lead [v-lead] via the left subclavian vein, the v lead detached within the patients left brachiocephalic vein. The physician inserted a snare device via the right femoral vein, to assist in removing the v lead from the patient's right ventricle. The physician states that during the extraction process, it is possible that the snare device contributed to the tricuspid valve damage because of the natural fulcrum point of the snare device through the tricuspid valve. The v lead was eventually captured with a snare and was successfully removed through the patient's right femoral vein. The following day, the patient became hypotensive. An echo study confirmed tricuspid regurgitation and avulsion of the patient's tricuspid valve leaflet. The patient was transferred to the surgery department for a semi emergent valve replacement. The tricuspid valve was unsuitable for repair, so replacement with a bioprosthesis valve was successfully performed. The right atrium was closed, the patient was weaned from cardiopulmonary bypass. The patient's postoperative course was uneventful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616662-2017-00016 |
| MDR Report Key | 6577219 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-18 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-05-18 |
| 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 | MR. CASEY HUGHES MS, CQE, CSQP |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8013164932 |
| Manufacturer G1 | MERIT MEDICAL IRELAND LTD. |
| Manufacturer Street | PARKMORE INDUSTRIAL ESTATE |
| Manufacturer City | BALLYBRIT, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EN SNARE |
| Generic Name | EN SNARE ENDOVASCULAR SNARE SYSTEM |
| Product Code | MMX |
| Date Received | 2017-05-18 |
| Catalog Number | EN2007030 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL IRELAND LTD. |
| Manufacturer Address | PARKMORE INDUSTRIAL ESTATE BALLYBRIT, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2017-05-18 |