MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-29 for EN SNARE EN2007030/A manufactured by Merit Medical Ireland Ltd.
[143417523]
The suspect device has been returned for evaluation. The complaint is confirmed. No definitive root cause could be determined however, it is likely that significant force was applied to the device during use. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
[143417524]
The account alleges that during an ivc filter removal procedure, the head of the vascular snare device detached. The clinician had successfully acquired antegrade venous access and during snare device manipulations, the head of the snare detached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616662-2019-00005 |
| MDR Report Key | 8560892 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-29 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-04-29 |
| 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 | MRS. KATIE SWENSON CQE,CBA,CQPA. |
| 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 BUSINESS PARK WEST BALLYBRIT |
| 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 | 2019-04-29 |
| Returned To Mfg | 2019-02-12 |
| Catalog Number | EN2007030/A |
| Lot Number | K1490574 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL IRELAND LTD |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST BALLYBRIT GALWAY, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-29 |