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 2020-03-18 for PERIPHERAL ROTALINK PLUS 29720 manufactured by Boston Scientific Corporation.
[183889525]
It was reported that the device went above the set operational speed. A 1. 25mm peripheral rotalink plus was selected for use. Upon ablation, the device worked for the first two passes in the vessel and was then moved to another. The set operational speed was 160,000rpm, however the device went above the set operational speed as it reached at 165,000rpm at one point. An attempt for burr rotation was made but the physician would let go of the pedal as it sounded as if air was coming from the handle. A sound was heard, and the stall light lit up as soon as the physician stepped on the pedal. This was tried repeatedly using the same device but with no success. The procedure was completed with another of the same device. No patient complications were reported and everything is fine with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03504 |
| MDR Report Key | 9847524 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-03-18 |
| 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 | PERIPHERAL ROTALINK PLUS |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 29720 |
| Catalog Number | 29720 |
| Lot Number | 0024597911 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-18 |