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

Model Number	29710
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Additionally, detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a burr and wire entrapment occurred.The patient presented with peripheral arterial disease.The target lesion was located in the mildly tortuous and moderately to severely calcified proximal to distal anterior tibial artery (ata).A 1.25 mm rotapro-pi and peripheral rotawire guidewire were selected for use in accordance with standard atherectomy indications.Burr advancement was performed using a pecking motion approximately 75% of the time.The burr was used close to the origin of the ata and traveled distally toward the pedal arteries.Midway through the ata, the burr began to stall, including during dynaglide mode.Advancement became difficult at the midpoint of the lesion.It was observed that the guidewire was not freely moving within the vessel and was moving together with the burr, indicating the burr had become stuck on the wire.Multiple attempts were made to dislodge the burr using both normal and dynaglide modes, but these were unsuccessful.The physician elected to remove the rotapro burr; however, it could not be extracted independently of the wire.Consequently, both the burr and guidewire were removed together as a single unit.Post-removal, an attempt was made to separate the wire from the burr assembly outside the patient.Despite using the brake defeat button per the directions for use (dfu), the wire remained engaged.The rotawire was noted to be slightly kinked approximately 3-5 cm from the distal tip.The procedure was successfully completed using angioplasty ballooning.No patient complications were reported.
Additional Manufacturer Narrative
A1: patient identifier updated.A2: date of birth: 1964.D4: lot number updated.
Event or Problem Description
It was reported that a burr and wire entrapment occurred.The patient presented with peripheral arterial disease.The target lesion was located in the mildly tortuous and moderately to severely calcified proximal to distal anterior tibial artery (ata).A 1.25 mm rotapro-pi and peripheral rotawire guidewire were selected for use in accordance with standard atherectomy indications.Burr advancement was performed using a pecking motion approximately 75% of the time.The burr was used close to the origin of the ata and traveled distally toward the pedal arteries.Midway through the ata, the burr began to stall, including during dynaglide mode.Advancement became difficult at the midpoint of the lesion.It was observed that the guidewire was not freely moving within the vessel and was moving together with the burr, indicating the burr had become stuck on the wire.Multiple attempts were made to dislodge the burr using both normal and dynaglide modes, but these were unsuccessful.The physician elected to remove the rotapro burr; however, it could not be extracted independently of the wire.Consequently, both the burr and guidewire were removed together as a single unit.Post-removal, an attempt was made to separate the wire from the burr assembly outside the patient.Despite using the brake defeat button per the directions for use (dfu), the wire remained engaged.The rotawire was noted to be slightly kinked approximately 3-5 cm from the distal tip.The procedure was successfully completed using angioplasty ballooning.No patient complications were reported.It was further reported that the patient was fine post procedure.

• 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 CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23214042
• Report Number: 2124215-2025-69408
• Device Sequence Number: 8890724
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: (01)08714729863649(17)270226(10)35950023
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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 Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0035950023
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/26/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 02/26/2025
• 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 Age: 61 YR
• Patient Sex: Male