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	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that an unstable speed occurred.A rotapro console was selected for use.At the course of the procedure, it was noted that the console had high revolutions per minute (rpm) and it was expected that the rpms should cut in half.However, the rpms remained high and the cycle was not completed.No patient complications reported.
Event or Problem Description
It was reported that an unstable speed occurred.A rotapro console was selected for use.At the course of the procedure, it was noted that the console had high revolutions per minute (rpm) and it was expected that the rpms should cut in half.However, the rpms remained high and the cycle was not completed.No patient complications reported.It was further reported that the issue was observed during in-service and in dynaglide mode.The procedural target speed was 160,000 rpm however console would only increase to 130,000 rpm.The set rotational speed was at 130,000 rpm and reached a maximum speed of 134,000 rpm.
Additional Manufacturer Narrative
H6: device code: corrected.
Event or Problem Description
It was reported that an unstable speed occurred.A rotapro console was selected for use.At the course of the procedure, it was noted that the console had high revolutions per minute (rpm) and it was expected that the rpms should cut in half.However, the rpms remained high and the cycle was not completed.No patient complications reported.It was further reported that the issue was observed during in-service and in dynaglide mode.The procedural target speed was 160,000 rpm however console would only increase to 130,000 rpm.The set rotational speed was at 130,000 rpm and reached a maximum speed of 134,000 rpm.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the complaint device was received for product analysis.Console is running firmware version v05.18.00.Console failed the final functional test on step 5 - offset-normal mode minimum flow rate - with a reading of 109.513 standard cubic feet per hour (scfh).The acceptable range is 45 +/-5 scfh.The pneumatic kit from the gold unit was swapped into the console and subsequently tested.That pairing passed the final functional test without failing at any step.Analysis of the device confirms that the reported event of unstable speed.Console failed the visual inspection because there are visible scratches on the front panel, the back label is damaged, and there are visible marks on the rear enclosure.

• 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): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21662912
• Report Number: 2124215-2025-15672
• Device Sequence Number: 20919542
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: (01)08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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: RP002456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 04/16/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/07/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown