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 2019-03-08 for EN SNARE ENDOVASCULAR SNARE SYSTEM EN2007030/A manufactured by Merit Medical Ireland Ltd.
[138347750]
The device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[138347751]
The account alleges that during an inferior vena cava [ivc] filter removal procedure, the tip of a vascular snare retrieval device detached within the patient. The physician had acquired retrograde venous access in attempt to capture and remove the [ivc] filter. While attempting to capture the filter, the snare head detached and remained on the ivc filter retrieval hook. The physician tried unsuccessfully to remove the detached snare tip and the ivc filter with another vascular snare device.
Patient Sequence No: 1, Text Type: D, B5
[140212143]
The suspect device was not returned for evaluation. The complaint could not be confirmed and a root cause could not be determined. A review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and one similar complaint for this lot number was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616662-2019-00003 |
| MDR Report Key | 8406009 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-03-08 |
| 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 ENDOVASCULAR SNARE SYSTEM |
| Generic Name | ENDOVASCULAR SNARE |
| Product Code | MMX |
| Date Received | 2019-03-08 |
| Catalog Number | EN2007030/A |
| Lot Number | K1490574 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Life Threatening; 2. Other; 3. Required No Informationntervention | 2019-03-08 |