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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3243
Device Problems Difficult or Delayed Activation (2577); Material Integrity Problem (2978); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a brake malfunction occurred.A percutaneous coronary intervention was being performed.This rotapro atherectomy system was selected for use.Before retracting the advancer, the brake defeat button was not working and the wireclip torque was unable to hold the wire into place and the device was unable to advanced.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patients status is stable.
 
Manufacturer Narrative
Age at time of event: 18 years or older.The returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The rotawire used in the procedure was also returned.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.Functional testing was performed by using a test wireclip torquer.During testing, the returned rotawire was able to be inserted into the wireclip torquer, and the wireclip torquer was able to be inserted into the rotapro advancer.The brake defeat button was held down with the wireclip torquer inserted with no issues.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was not able to be rotated.The rotapro advancer was then connected to the rotapro control console system.The knob switch (ablation button) was pressed, but the device stalled and would not get any speed.In order to determine the cause of the stall, destructive testing was performed.The advancer was dismantled and the components inside the advancer were inspected, but destructive testing was not conclusive as there were no damages to the components.There is not enough evidence to definitively say what the cause of the device stall was.Product analysis could not confirm the reported events, as the wireclip torquer was able to be inserted and held down the brake defeat button with no issues.The reported advancer activation issues could not be confirmed, as the device stalled when the ablation button was pressed.Therefore, it was not determined if the knob switch could turn the advancer on and off.
 
Event Description
It was reported that a brake malfunction occurred.A percutaneous coronary intervention was being performed.This rotapro atherectomy system was selected for use.Before retracting the advancer, the brake defeat button was not working and the wireclip torque was unable to hold the wire into place and the device was unable to advanced.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patients status is stable.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12313926
MDR Text Key266243084
Report Number2134265-2021-10340
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893363
UDI-Public08714729893363
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/25/2022
Device Model Number3243
Device Catalogue Number3243
Device Lot Number0026079043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Date Manufacturer Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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