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

Model Number	H802228240020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that tip detachment occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending artery.A rotowire was selected for rotablation.During withdrawal, it was noted that a piece of the guidewire approximately 1 cm was missing from the tip, which remained in a very distal position inside the patient.Due to its distal location, the detached tip could not be retrieved using a snare.The device was note removed in one piece.The procedure was completed with the original device.There were no patient complications, and the patient was in good condition without any complications.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic inspection showed that a portion of the spring tip had detached and was not returned for analysis.Dimensional measurements were performed, and the specification required a total length of 130.0 inches, plus or minus one inch, with an upper limit of 131.0 inches and a lower limit of 129.0 inches.The returned guidewire measured 129.5 inches, indicating that the overall length remained within specification despite the missing portion of the spring tip.Review of the available media, including an angiogram video, confirmed that a segment of the spring tip had detached and remained inside the patient.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that tip detachment occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending artery.A rotowire was selected for rotablation.During withdrawal, it was noted that a piece of the guidewire approximately 1 cm was missing from the tip, which remained in a very distal position inside the patient.Due to its distal location, the detached tip could not be retrieved using a snare.The device was note removed in one piece.The procedure was completed with the original device.There were no patient complications, and the patient was in good condition without any complications.

• 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: 23550128
• Report Number: 2124215-2025-82872
• Device Sequence Number: 13091971
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: (01)08714729185871(17)270307(10)36018976
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 0036018976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown