MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM manufactured by Boston Scientific Corporation.
[185944633]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[185944654]
It was reported that the rotawire tip was separated. The 90% stenosed target lesion was located in the severely calcified artery. A 330cm rotawire and a rotaburr were selected for use. During procedure, it was noted that the spring coil of the radiopaque (ro) marker at the wire tip was loosened and was found to be separated under cine. The devices were removed for each system and the procedure was completed with another of the same device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04118 |
| MDR Report Key | 9908854 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-31 |
| 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 CORK LIMITED |
| 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 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-31 |
| 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 | 2020-03-31 |