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

Model Number	H749394672150
Medical Device Problem Codes	Break (1069); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that there was a hole on the shaft.The stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 2.15mm rotapro was selected for use.During the procedure, after cutting with the rotaburr, the drive shaft sheath was removed as usual outside the body, and when the drive shaft sheath was checked, it was found that there was a hole in the drive shaft sheath.There was also an unusual noise during the procedure.The procedure was completed with this device.There were no patient complications reported post procedure.
Event or Problem Description
It was reported that there was a hole on the shaft.The stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 2.15mm rotapro was selected for use.During the procedure, after cutting with the rotaburr, the drive shaft sheath was removed as usual outside the body, and when the drive shaft sheath was checked, it was found that there was a hole in the drive shaft sheath.There was also an unusual noise during the procedure.The procedure was completed with this device.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer.Inspection of the device found that at 22.8cm distal from the strain relief, the sheath was flattened (damaged).Inspection of the device found that at 22.8cm distal from the strain relief, the sheath was torn.When the rotapro advancer was connected to the rotapro console and the ablation button was pressed, the device stalled and did not run.The sound of air escaping the device could be heard during the stall.

• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20665691
• Report Number: 2124215-2024-69009
• Device Sequence Number: 8237841
• Product Code: MCX
• UDI-Device Identifier: 08714729999607
• UDI-Public: 08714729999607
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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 Expiration Date: 05/17/2025
• Device Model Number: H749394672150
• Device Catalogue Number: H749394672150
• Device Lot Number: 0031642994
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC LAUNCHER - GUIDE CATHETER; MEDTRONIC LAUNCHER - GUIDE CATHETER; TERUMO ALTAVIEW - IMAGING CATHETER; TERUMO ALTAVIEW - IMAGING CATHETER
• Patient Sex: Unknown