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 2020-03-24 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.
[184742778]
It was reported that device entrapment and vessel dissection occurred. A 1. 25mm rotapro and rotawire and wireclip torquer were selected for use in the tortuous mid right coronary artery. The rotawire was advanced without difficulty through and beyond the lesion. During the procedure, the 1. 25 burr stopped in the middle of the lesion. No stall had displayed and the rpms did not drop below 150,000rpm. The burr became lodged in the lesion and stuck on the wire. Significant resistance was experienced when attempting to remove or advance the burr. Neither the wire nor burr would move forward or backward. The burr and the wire seemed to be fused and entrapped together. In order to remove the device, the burr and wire had to be forcefully removed together and a dissection of the right coronary artery occurred. A covered stent had to be placed. The dissection was fixed and the patient was stable post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03739 |
| MDR Report Key | 9871715 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-07-15 |
| Date Added to Maude | 2020-03-24 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTAPRO |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-24 |
| Model Number | 3243 |
| Catalog Number | 3243 |
| Lot Number | 0024108640 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |