MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for MERRIT PRECLUDE DEAL SHEATH REF #PID6F11018NTPD manufactured by Merit Medical Systems, Inc..
[183355196]
During replacement of the right radial merrit sheath, we had a failure of the dilator which separated and was freely dislodged in the right radial artery, 6f radial sheath dilator broke off from the hub into the pt's arm. Using a snare we successfully removed the entire dilator, all foreign material removed. Merrit rep has been notified and all sheath equipment secured. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093695 |
| MDR Report Key | 9823677 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-19 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | MERRIT PRECLUDE DEAL SHEATH |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-03-11 |
| Model Number | REF #PID6F11018NTPD |
| Lot Number | H1740235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |