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 2018-05-10 for EN SNARE MINI EN1003008/A manufactured by Merit Medical Ireland Ltd.
[107956316]
The suspect 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
[107956317]
The account alleges that during a percutaneous transluminal cardiovascular intervention [pci], and left heart cath [lhc] procedure, a competitors interventional coronary guidewire detached within the patient's left circumflex artery. The physician attempted to retrieve the foreign body from the patient with a vascular snare device when a fragment of the vascular snare had detached within the patients left circumflex artery as well. The physician tried to retrieve the snare fragment from the patient but was unsuccessful. The patient received additional radiation exposure during the primary foreign body retrieval attempt. Three days later, the snare fragment was successfully retrieved from the patient via another vascular snare device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616662-2018-00009 |
| MDR Report Key | 7505076 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-10 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2018-05-10 |
| 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 |
| 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 INDUSTRIAL ESTATE |
| Manufacturer City | GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EN SNARE MINI |
| Generic Name | ENDOVASCULAR SNARE SYSTEM |
| Product Code | MMX |
| Date Received | 2018-05-10 |
| Returned To Mfg | 2018-05-25 |
| Catalog Number | EN1003008/A |
| Lot Number | K879025 |
| Device Expiration Date | 2018-10-31 |
| Operator | PHYSICIAN |
| 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 INDUSTRIAL ESTATE GALWAY, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-05-10 |