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

Model Number	3520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 (b)(6).
Event or Problem Description
It was reported that the tip detached.The 80% stenosed target lesion was located at the proximal segment of left anterior descending branch.A 330cm rotawire was selected for use.During preparation, after the guidewire was unpacked, it was noted that the coil at the tip was detached.The device was completed with another of the same device.There were no patient complications and patient was stable.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).Investigation results: media review: during the media analysis, the media attached shows the wire detached from the distal tip which confirms the as reported guidewire, detachment of device or device component, but it does not show enough evidence to identify a device defect that could have contributed to the reported complaint.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of unable to exclude device problem, following a review of the reported event details, available information, and product record review.Improper handling, device manipulation or not following the correct instructions during the procedure, could be contributing factors to the reported issue.However, there is no additional detail pertinent to the event.
Event or Problem Description
It was reported that the tip detached.The 80% stenosed target lesion was located at the proximal segment of left anterior descending branch.A 330cm rotawire was selected for use.During preparation, after the guidewire was unpacked, it was noted that the coil at the tip was detached.The device was completed with another of the same device.There were no patient complications and patient was stable.

• 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: 24269685
• Report Number: 2124215-2026-06598
• Device Sequence Number: 10669550
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)270118(10)35661112
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 03/20/2026

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: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0035661112
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 01/18/2025
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 55 KG