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 2018-01-25 for EN SNARE EN2007030 manufactured by Merit Medical Ireland Ltd.
[98276188]
The suspect device is not expected to return for evaluation. A review of the complaint database and device history record could not be performed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[98276189]
The account alleges that during retrieval of a fractured left ventricular assist device [lvad] the loop on the vascular snare detached within the patient. The detached vascular snare loop was retained within the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616662-2018-00002 |
| MDR Report Key | 7220119 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2018-01-10 |
| Date Added to Maude | 2018-01-25 |
| 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 | RISK MANAGER |
| 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 | 8012531600 |
| Manufacturer G1 | MERIT MEDICAL IRELAND LTD |
| Manufacturer Street | PARKMORE INDUSTRIAL ESTATE |
| Manufacturer City | GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EN SNARE |
| Generic Name | ENDOVASCULAR SNARE SYSTEM |
| Product Code | MMX |
| Date Received | 2018-01-25 |
| 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 GALWAY, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-25 |