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 2019-03-28 for EN SNARE EN2006010/A manufactured by Merit Medical Ireland Ltd.
[140177078]
The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[140177079]
The account alleges that during a foreign body retrieval procedure, a vascular snare device detached within the patient. Another vascular snare device was successfully used to retrieve both foreign body and the detached snare device with no additional consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616662-2019-00004 |
| MDR Report Key | 8460300 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2016-12-16 |
| Date Added to Maude | 2019-03-28 |
| 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 | 2019-03-28 |
| Returned To Mfg | 2019-03-14 |
| Catalog Number | EN2006010/A |
| Lot Number | K1066573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-28 |