MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Output Problem (3005); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 18 years old.
Event or Problem Description
It was reported that the rotawire became stuck to the rotapro catheter.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A rotawire and rotapro catheter were selected to treat the lesion.Post ablation the devices were attempted to be removed in dynaglide mode.There was severe resistance and the devices were stuck together.As the devices were being removed at a lower rotational speed the system stalled.The rotawire and rotapro catheter were removed together as one unit.The procedure was completed with a different model device.No patient complications were reported and the patient condition was good post procedure.
Event or Problem Description
It was reported that the rotawire became stuck to the rotapro catheter.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A rotawire and rotapro catheter were selected to treat the lesion.Post ablation the devices were attempted to be removed in dynaglide mode.There was severe resistance and the devices were stuck together.As the devices were being removed at a lower rotational speed the system stalled.The rotawire and rotapro catheter were removed together as one unit.The procedure was completed with a different model device.No patient complications were reported and the patient condition was good post procedure.
Additional Manufacturer Narrative
A2: age at time of event - over 18 years old.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 returned within the rotapro device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.During analysis, the returned wire was able to be removed and reinserted into the returned device without resistance or 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.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12160666
• Report Number: 2134265-2021-08920
• Device Sequence Number: 4723482
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Expiration Date: 01/18/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026651314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1