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

Model Number	3243
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on guidewire.A 1.75mm rotapro and rotawire guidewire were selected for use.During the procedure, the rotapro burr seized firmly on the wire and could no longer be separated, and the burr could no longer go forward or backwards.Rotawire and burr were removed together as one unit.The procedure was completed successfully using another rotapro and rotawire.There was no patient complications reported, and patient was stable post procedure.
Event or Problem Description
It was reported that the burr was stuck on guidewire.A 1.75mm rotapro and rotawire guidewire were selected for use.During the procedure, the rotapro burr seized firmly on the wire and could no longer be separated, and the burr could no longer go forward or backwards.Rotawire and burr were removed together as one unit.The procedure was completed successfully using another rotapro and rotawire.There was no patient complications reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system with the related rotawire within the device.Inspection of the device found that at 61cm-61.7cm distal from the strain relief, the sheath was kinked (flattened).Product analysis confirmed the reported event, as there were kinks to the returned rotawire which caused resistance during removal and insertion.Additionally, the sheath was kinked.

• 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: 20039068
• Report Number: 2124215-2024-52472
• Device Sequence Number: 20467253
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 10/26/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0030430782
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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