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

Model Number	39467-200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck in lesion.Also, the burr became stuck on wire.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery (lad).A 2.00mm rotapro and rotawire drive were selected for percutaneous coronary intervention (pci).During the procedure, at the first ablation, the rpm dropped by 5,000.The entry point was slightly ablated, and on the second attempt, further ablation was performed deeper, but the device got pulled into the calcified lesion and became stuck.With forceful pulling, it was retrieved.The wire had lodged into the tip and came out together.The entrapment was strong, and it could not be removed outside the body, so reuse was abandoned.Both the catheter and wire were replaced to continue.The new ones were used without any issues.Both the wire and the burr were completely removed from the patient's body completely by pulling with a little force and the procedure was completed with another of the same device.No complications were reported.

• 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 SCIMED, INC; 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: 20363047
• Report Number: 2124215-2024-61157
• Device Sequence Number: 9592875
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/03/2024

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: 04/29/2026
• Device Model Number: 39467-200
• Device Catalogue Number: 39467-200
• Device Lot Number: 0033923428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/03/2024
• Date Device Manufactured: 04/29/2024
• 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: Unknown