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 2017-05-10 for ENSNARE ENDOVASCULAR SNARE SYSTEM EN2006020/A manufactured by Merit Medical Ireland Ltd..
[74853013]
The suspect device is not expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[74853014]
The account alleges that during a biliary stent retrieval procedure the snare was damaged. When the physician removed the snare from the patient he inadvertently punctured his thumb on the damaged portion of the snare device. The damage was alleged to be at the at the distal junction weld from which all three snare loops protrude. The physician was tested for blood born pathogen exposure per hospital policy and received minor first aid for his wound.
Patient Sequence No: 1, Text Type: D, B5
[76208797]
The suspect device was not returned for evaluation. The complaint could not be confirmed. The root cause could not be determined. A review of the complaint database was performed and no similar complaints were found for this lot number. A review of the device history record was performed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616662-2017-00015 |
| MDR Report Key | 6558167 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-10 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2017-01-16 |
| Date Added to Maude | 2017-05-10 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| 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 | 8013164932 |
| Manufacturer G1 | MERIT MEDICAL IRELAND LTD. |
| Manufacturer Street | PARKMORE INDUSTRIAL ESTATE |
| Manufacturer City | BALLYBRIT, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENSNARE ENDOVASCULAR SNARE SYSTEM |
| Generic Name | ENDOVASCULAR SNARE SSTEM |
| Product Code | MMX |
| Date Received | 2017-05-10 |
| Catalog Number | EN2006020/A |
| Lot Number | K1070354 |
| Device Expiration Date | 2019-12-31 |
| Operator | PHYSICIAN |
| 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 INDUSTRIAL ESTATE BALLYBRIT, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-10 |