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 2020-03-30 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.
[185667205]
Device evaluated by manufacture. Returned product consisted of a rotapro and a rotawire. The advancer, burr, coil and handshake connection were visually examined. Analysis of the device found that the burr was stuck on the rotawire and was unable to be removed. Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate. Inspection of the remainder of the device presented no other damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10
[185667206]
It was reported that the rotawire became kinked and became stuck in the rotapro device. A 1. 50mm rotapro and rotapro rotawire and wireclip torquer were used in an atherectomy procedure. During the withdrawal, the rotawire was kinked and became stuck with the rotapro device. The rotapro and rotawire were removed together from the patient as one unit. Upon removal it was discovered that the rotawire became separated, but there was no separated part left in the patient body. The procedure was completed with another of same device. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04001 |
| MDR Report Key | 9897759 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-24 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Returned To Mfg | 2020-01-23 |
| Model Number | 3243 |
| Catalog Number | 3243 |
| Lot Number | 0024162114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-30 |