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

Model Number	3256
Medical Device Problem Codes	Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rotation speed was unstable.A 1.50mm rotapro and a rotapro console were selected for use in a percutaneous coronary intervention to treat coronary artery disease.During preparation, the rotapro platformed successfully at 160,000 rotations per minute (rpm) outside the body.During the procedure, the device was advanced into the body, and one ablation run was successfully performed.During the second ablation run, the speed increased from 160,000 rpm to 200,000 rpm.A weird noise was heard, and it was audibly noted that the speed seemed to increase as well.An attempt was made to reduce the rotation speed by turning the knob, but there was no response.The device was removed.The procedure was completed by placing a synergy stent.No patient complications were reported.The patient was fine.

• 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: 11381326
• Report Number: 2134265-2021-02300
• Device Sequence Number: 14313554
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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 Model Number: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP002126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1