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

Model Number	3520
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by manufacturer.The complaint device was received for product analysis.During a visual and microscope inspection, the spring tip was observed bent/stretched and a portion of it was detached and did not return for analysis.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 20oct2025 it was reported that device could not cross the lesion.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending.A rotawire was selected for use.During the procedure, the device could not cross the lesion.There were no patient complications.However, device analysis revealed that a detached portion of the spring tip was noted.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23569204
• Report Number: 2124215-2025-81344
• Device Sequence Number: 10155661
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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 Expiration Date: 01/13/2025
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0030853546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• 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 Age: 53 YR
• Patient Sex: Male