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

Model Number	3256
Medical Device Problem Codes	Unstable (1667); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled and rescheduled post sedation.Two 1.50mm rotapro catheters and a rotapro console were selected for use in an atherectomy procedure.The patient was sedated.During preparation, the first 1.50mm rotapro started at a rotation speed of 250,000 rotations per minute (rpm), but the burr sounded very slow.It also sounded like the speed was fluctuating up and down as if the device was working harder than usual.The speed on the console remained at 250,000 rpm this entire time.The system was disconnected and reconnected, the gas pressure was checked, and the system was turned back on.The catheter was exchanged for another of the same.The second 1.50mm rotapro started at 170,000 rpm then quickly dropped to 150,000 rpm.The burr sounded like the first device did.The procedure was cancelled and rescheduled for (b)(6) 2021.Neither catheter ever entered the body.No patient complications were reported.
Additional Manufacturer Narrative
H6 device codes corrected.The rotapro console serial number (b)(6) was returned for analysis in over all good physical condition.The unit passed all incoming functional tests and the fault condition could not be replicated.The rotapro passed calibration and full functional final testing.
Event or Problem Description
It was reported that the procedure was cancelled and rescheduled post sedation.Two 1.50mm rotapro catheters and a rotapro console were selected for use in an atherectomy procedure.The patient was sedated.During preparation, the first 1.50mm rotapro started at a rotation speed of 250,000 rotations per minute (rpm), but the burr sounded very slow.It also sounded like the speed was fluctuating up and down as if the device was working harder than usual.The speed on the console remained at 250,000 rpm this entire time.The system was disconnected and reconnected, the gas pressure was checked, and the system was turned back on.The catheter was exchanged for another of the same.The second 1.50mm rotapro started at 170,000 rpm then quickly dropped to 150,000 rpm.The burr sounded like the first device did.The procedure was cancelled and rescheduled for february 22, 2021.Neither catheter ever entered the body.No patient complications were reported.

• 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: 11385859
• Report Number: 2134265-2021-02458
• Device Sequence Number: 3444072
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 05/10/2021

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: RP000684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1