MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-13 for EN SNARE EN2006015 manufactured by Merit Medical Ireland Ltd.
[113907537]
The suspect device has returned for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[113907538]
The account alleges that during a percutaneous transluminal angioplasty procedure, the marker band from a snare delivery catheter detached within a patient. The patient was placed in the supine position on the exam table and the vascular access site was prepped and draped in a sterile fashion. A local anesthetic was administered to numb the skin for comfort and access sheath placement. While manipulating a vascular snare delivery catheter to capture an interventional wire within the patient's lower periphery, the marker band on the snare delivery catheter detached. The physician then used the vascular snare device to successfully retrieve the marker band from the patient's vasculature leading to only a moderate delay in procedure.
Patient Sequence No: 1, Text Type: D, B5
[118132425]
The suspect device was returned for evaluation. The device was examined visually. The complaint is confirmed. The root cause is unknown. A review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and no similar complaints for this lot number were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616662-2018-00013 |
| MDR Report Key | 7685689 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-13 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-08-15 |
| Device Manufacturer Date | 2016-04-25 |
| Date Added to Maude | 2018-07-13 |
| 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 | EN SNARE ENDOVASCULAR SNARE SYSTEM |
| Product Code | MMX |
| Date Received | 2018-07-13 |
| Returned To Mfg | 2018-07-04 |
| Catalog Number | EN2006015 |
| Lot Number | K951290 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-07-13 |