ROTABLATOR?
Report
- Report Number
- 2124215-2025-18095
- Event Type
- Malfunction
- Date Received
- April 4, 2025
- Date of Event
- March 8, 2025
- Report Date
- April 1, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MCW
- UDI-DI
- 08714729353317
- PMA / PMN Number
- K121774
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B - PRO CODE: MCX. G4 - PREMARKET / 510(K) #: P900056.
INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE CAUSE OF THE REPORTED PROCEDURE CANCELLED/RESCHEDULED EVENT WAS DUE TO THE FOOT PEDAL NOT WORKING, BUT THE CAUSE FOR THE FOOT PEDAL NOT WORKING COULD NOT BE DETERMINED. THE INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS SELECTED.
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. ACE ROTABLATOR WAS SELECTED FOR USE. PRIOR TO PROCEDURE, THE FOOT PEDAL DYNAGLIDE MODE WAS NOT WORKING. THE CASE WAS POSTPONED, AND THERE WAS NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A CE ROTABLATOR WAS SELECTED FOR USE. PRIOR TO PROCEDURE, THE FOOT PEDAL DYNAGLIDE MODE WAS NOT WORKING. THE CASE WAS POSTPONED, AND THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112824 | ROTABLATOR? | CATHETER, PERIPHERAL, ATHERECTOMY | MCW | BOSTON SCIENTIFIC CORPORATION | H802224360021 | FP47416 | 08714729353317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |