MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for MERIT MAK? 00884450012598 MAK401N-E/C manufactured by Merit Medical Systems, Inc..
[183271884]
Elderly female with history of coronary artery disease, elevated cholesterol and asthma. During the procedure- transcatheter aortic valve replacement (tavr), the wire got stuck in the mini stick sheath access and had to be removed. Access had to be regained, without known harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9828861 |
| MDR Report Key | 9828861 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-13 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIT MAK? |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-03-13 |
| Model Number | 00884450012598 |
| Catalog Number | MAK401N-E/C |
| Lot Number | L1693920 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1600 WEST MERIT PARKWAY SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |