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

Model Number	3256
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that speed is unable to be adjusted.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).Two rotapro console kit assy ul/ csa were selected for use.During the procedure, the rpm read out for dynaglide was at 150,000 rpm.Also, it was noted that the speed control is not working and the speed cannot be adjusted.The procedure was completed using this device.No complications were reported and the patient was stable after the procedure.
Event or Problem Description
It was reported that speed is unable to be adjusted.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).Two rotapro console kit assy ul/ csa were selected for use.During the procedure, the rpm read out for dynaglide was at 150,000 rpm.Also, it was noted that the speed control is not working and the speed cannot be adjusted.The procedure was completed using this device.No complications were reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Console failed the final functional test on step 3.1 normal advancer simulator knob button initial flow with a reading of 122.900 standard cubic feet per hour (scfh).The acceptable range is 112 to 122 scfh.The pneumatic kit from the gold unit was swapped into the console and subsequently tested.That pairing failed the final functional test on step 3.1 with a reading of 122.203 (scfh).The original pneumatic kit was then paired with the gold unit's front panel.That pairing passed the final functional test without failing at any step.Console failed the visual inspection because there is a visible front scratch on the front panel.In addition, there are visible dents and marks on the rear panel.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20494560
• Report Number: 2124215-2024-64585
• Device Sequence Number: 4096494
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P900056/S166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: RP002838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown