MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number	22020-039-L
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.  (b)(4).
Event or Problem Description
It was reported that the speed was fluctuating.A rotablator console was selected for use.However, it was noted that the device was unable to maintain desired rotations per minute and the speed was fluctuating.Also, air leakage was noted.The console and the foot pedal were replaced.No patient involved.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main pedal of a known foot pedal was pressed and the rpm displayed 333,000 instead of 990,000 on the speed indicator.In addition, the turbine pressure has decreased by more than 5psi/60 seconds.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of the failure are the control board and the proportional valve.The investigation conclusion is wear and tear as the reported device or component failure was due to long or extended use.(b)(4).
Event or Problem Description
It was reported that the speed was fluctuating.A rotablator console was selected for use.However, it was noted that the device was unable to maintain desired rotations per minute and the speed was fluctuating.Also, air leakage was noted.The console and the foot pedal were replaced.No patient involved.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• MDR Report Key: 7005738
• Report Number: 2134265-2017-10523
• Device Sequence Number: 1298457
• Product Code: MCX
• UDI-Device Identifier: 08714729719601
• UDI-Public: 08714729719601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 22020-039-L
• Device Catalogue Number: 22020-039-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1