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

Model Number	3243
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr detached resulting in a prolonged procedure.During a rotablation procedure, the burr stopped rotating.A break between the burr and the advancer was noted and the burr was released near the proximal right coronary artery.This event resulted in medical delay and increased stress for the patient and medical staff.However, the burr was successfully extracted from the body and the patient was reportedly fine after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The device was received with the burr separated within a piece of returned guide catheter.The advancer, drive shaft, handshake connections, housing, sheath, coil, and burr were visually, microscopically, and x-ray examined.Inspection of the device found that the coil had been stretched at the point of detachment from the burr and that the burr was detached from the coil.The coil was also found to be kinked and stretched at the handshake connection.Functional testing was performed by attempting to rotate the drive shaft, but the drive shaft was not able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch [ablation button] was pressed, the device stalled and was not able to run due to the damaged coil.
Event or Problem Description
It was reported that the burr detached resulting in a prolonged procedure.During a rotablation procedure, the burr stopped rotating.A break between the burr and the advancer was noted and the burr was released near the proximal right coronary artery.This event resulted in medical delay and increased stress for the patient and medical staff.However, the burr was successfully extracted from the body and the patient was reportedly fine after the procedure.

• 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: 17899596
• Report Number: 2124215-2023-55753
• Device Sequence Number: 11604708
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 03/29/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031340541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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
• Patient Sex: Female