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

Model Number	H74939462001
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that device detachment occurred.The 90% stenosed target lesion was located in the severely calcified mid right coronary artery.A rotawire drive was selected for use during a percutaneous coronary intervention for the treatment of the coronary artery disease.During the procedure, the tip of a rotawire floppy broke off inside the patient.After the wire tip broke off, the device was removed and the remaining wire tip was stented to keep it in place.There were no complications, and patient was discharged and expected to fully recover.
Event or Problem Description
It was reported that device detachment occurred.The 90% stenosed target lesion was located in the severely calcified mid right coronary artery.A rotawire drive was selected for use during a percutaneous coronary intervention for the treatment of the coronary artery disease.During the procedure, the tip of a rotawire floppy broke off inside the patient.After the wire tip broke off, the device was removed and the remaining wire tip was stented to keep it in place.There were no complications, and patient was discharged and expected to fully recover.
Additional Manufacturer Narrative
Investigation results: the complaint device was received for product analysis.During visual inspection, portion of the spring tip was detached and did not return for analysis.Spring tip was observed bent and stretched.The bent was measured from distal to proximal according to drawing, and the distance where the bent was found is 0.3 inches.The total length of the guidewire was measured and found to be 129.5 inches.According to the specifications, the acceptable length range is 130.0 inches plus or minus 1.0 inch, with an upper limit of 131.0 inches and a lower limit of 129.0 inches.This means that the guidewire was returned complete for analysis.This concludes that the overall length was between the specification established on the drawing, even though a portion of the spring tip was detached and did not return for analysis.No other issues were identified during the product analysis.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 adverse event related to patient condition.This conclusion is based on the information provided and analysis performed.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• Brand Name: ROTAWIRE? DRIVE 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: 25150231
• Report Number: 2124215-2026-25586
• Device Sequence Number: 16134968
• Product Code: MCX
• UDI-Device Identifier: 08714729996255
• UDI-Public: (01)08714729996255(17)270303(10)35978762
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: H74939462001
• Device Catalogue Number: H74939462001
• Device Lot Number: 0035978762
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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; Required Intervention
• Patient Sex: Unknown