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

Model Number	29710
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire broke off and was unretrieved.The patient was not discharged from the hospital.The 89% stenosed target lesion was located in the mildly tortuous and moderately calcified segment from the popliteal artery to the proximal anterior tibial artery.A per rota wire exsup was selected for left leg atherectomy.During the procedure, the wire was checked if it is still in place and a small piece of the end of the wire was noticed to be separated from the wire itself.A spider filter was placed beyond the piece of the wire in the hopes of capturing it after a few tries without success and a small segment of the tip at 5mm in length remains and will remain in the patient's distal at/pedal artery.An over the wire (otw) sterling balloon was inflated in the at artery (above the wire piece) as would normally be done after atherectomy.No flow was observed for a short segment from distal popliteal to proximal at artery.Additionally, it was noticed that the distal popliteal as well as the proximal at artery was thrombosed.Patient was transferred to the hospital to have a catheter placed for thrombolysis across area that was thrombosed.The procedure was completed.The patient was not discharged from the hospital and the patient was stable.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22159740
• Report Number: 2124215-2025-34636
• Device Sequence Number: 12579249
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: (01)08714729863649(17)261213(10)35488482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

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 Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0035488482
• 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: 05/13/2025
• Initial Report FDA Received Date: 06/06/2025
• Date Device Manufactured: 12/13/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female