ROTABLATOR?
Report
- Report Number
- 2124215-2025-25562
- Event Type
- Malfunction
- Date Received
- May 5, 2025
- Date of Event
- April 8, 2025
- Report Date
- May 20, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MCW
- UDI-DI
- 08714729353317
- PMA / PMN Number
- K121774
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
E1: INITIAL REPORTER ADDRESS 1: (B)(6).
D4: CATALOG NUMBER: CORRECTED. D4: MODEL NUMBER: CORRECTED. D2B: PRO CODE (PRODUCT CODE): MCX. G4: PREMARKET/510(K) #: P900056. E1: INITIAL REPORTER ADDRESS 1: (B)(6).
IT WAS REPORTED THAT DEVICE FAILURE TO ADJUST SPEED OCCURRED. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO SWITCH BETWEEN HIGH AND LOW SPEED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT IS STABLE, SEDATED WITH LOCAL ANESTHESIA, AND WITH NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED.
IT WAS REPORTED THAT DEVICE FAILURE TO ADJUST SPEED OCCURRED. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO SWITCH BETWEEN HIGH AND LOW SPEED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT IS STABLE, SEDATED WITH LOCAL ANESTHESIA, AND WITH NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469474 | ROTABLATOR? | CATHETER, PERIPHERAL, ATHERECTOMY | MCW | BOSTON SCIENTIFIC CORPORATION | H802224360021 | RC400256 | 08714729353317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |