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	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that the speed could not be adjusted.A rotablator console was selected for use.It was noted that the speed could not be adjusted and would stay locked at 250,000 rpm.There was no patient involved.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The console and the foot pedal were tested using a functional generator with frequencies from 3.35 khz to 29.9khz and the reading were 99000 rpm and 888000 rpm.By using rotablator turbine model tester, the rpm was floating from 99000 to 100000 rpm.These are typical operational speeds.The foot pedal functioned properly, readily activating/deactivating the rotation and switching the console between turbine and dynaglide modes.Leak test was also performed with turbine model tester and the pressure gauge psi reading has not decreased by 5 psi.The unit passed the rotablator system functional test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that the speed could not be adjusted.A rotablator console was selected for use.It was noted that the speed could not be adjusted and would stay locked at 250,000 rpm.There was 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: 7550290
• Report Number: 2134265-2018-04866
• Device Sequence Number: 18903185
• Product Code: MCX
• UDI-Device Identifier: 08714729719601
• UDI-Public: 08714729719601
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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
• Device Lot Number: RC400248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1