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

Model Number	29711
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire detached, and additional surgery was required.The 90% stenosed target lesion was located in the severely calcified artery.A rotawire was selected for atherectomy.During procedure, following rotablation, a sterling balloon would not advance over the wire and the wire appeared kinked.The wire then broke into two pieces, mid wire.Furthermore, the patient underwent endarterectomy and the distal end of the rotawire was successfully removed.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
D4: lot number: corrected from unknown to (b)(4).
Event or Problem Description
It was reported that the wire detached, and additional surgery was required.The 90% stenosed target lesion was located in the severely calcified artery.A rotawire was selected for atherectomy.During procedure, following rotablation, a sterling balloon would not advance over the wire and the wire appeared kinked.The wire then broke into two pieces, mid wire.Furthermore, the patient underwent endarterectomy and the distal end of the rotawire was successfully removed.The procedure was completed.No patient complications were reported.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18848565
• Report Number: 2124215-2024-11689
• Device Sequence Number: 20490874
• Product Code: MCW
• UDI-Device Identifier: 08714729838890
• UDI-Public: 08714729838890
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2025
• Device Model Number: 29711
• Device Catalogue Number: 29711
• Device Lot Number: 0032895339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown