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

Model Number	3520
Medical Device Problem Codes	Nonstandard Device (1420); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11mar2026.It was reported that the wire tip was stretched.The 23mm x 3.0mm in diameter, 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.During unpacking of the rotawire, it was found that the tip of the guide wire was stretched and could not be operated.After 3 to 4 attempts, it still could not be used.The procedure was completed with another of the same wire.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that the wire was detached.
Additional Manufacturer Narrative
(b)(6).Investigation results: device analysis findings: device evaluated by manufacturer: the device was returned for analysis.Inspection of the device revealed that the wire was found detached from the distal end at 13cm.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.During the product analysis it was found the distal end detached, another portion detached did not return for analysis causing it not be possible to identify the most probable cause of the reported event, and batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issue.

• 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: 24790975
• Report Number: 2124215-2026-18536
• Device Sequence Number: 18617264
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)270124(10)35703266
• 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
• Report Date (Section B): 04/06/2026

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: 0035703266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 45 KG