MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	3560
Medical Device Problem Codes	Entrapment of Device (1212); Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr got stuck on wire.A rotawire guidewire was selected for use and was dressed with a wet compress upon unpacking.The rotawire guidewire and rotapro device were used together during the procedure.During pullback of the devices, it was difficult to track the rotapro burr on the guidewire and the wire appeared blunt.The rotawire was removed manually and in dynaglide mode.The rotawire guidewire was removed intact and the procedure was able to be completed with the same rotapro device.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter telephone: (b)(6).Device evaluated by manufacturer: the rotawire: ic device was returned for investigation.Visual and microscopic investigation confirmed the spring tip was observed to be bent and stretched.
Event or Problem Description
It was reported that the burr got stuck on wire.A rotawire guidewire was selected for use and was dressed with a wet compress upon unpacking.The rotawire guidewire and rotapro device were used together during the procedure.During pullback of the devices, it was difficult to track the rotapro burr on the guidewire and the wire appeared blunt.The rotawire was removed manually and in dynaglide mode.The rotawire guidewire was removed intact and the procedure was able to be completed with the same rotapro device.No patient complications were reported.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17475400
• Report Number: 2124215-2023-41879
• Device Sequence Number: 12598044
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 01/24/2025
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0030922012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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: Unknown