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

Model Number	H802228240020
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that guidewire was kinked.The 98% stenosed target lesion was located in the severely tortuous and severely calcified artery.A rotawire was selected for use.During the procedure, the guidewire was kinked.The procedure was completed using an alternate method.There were no patient complications.However, device analysis revealed that the guidewire was detached.
Additional Manufacturer Narrative
E1-initial reporter address 1: (b)(6) hospital (b)(6).Investigation results: the complaint device was received for product analysis.During visual inspection, the device was returned split in two pieces and with the wireclip torquer.The body of the guidewire was kinked.Microscopic inspection observed a kink in the spring tip.The total length of the guidewire was measured and found to be 130.0 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 overall length was between the specification established on the drawing.Additionally, the distance where the detachment was found is at 53.4 inches.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 supported by the following objective evidence regarding the reported issue of guidewire kinked and the additional failure.Based on the information provided and analysis performed, it is most likely the presence of reported anatomical factors, presented a constriction over the device and increase the friction when the device was advancing through the lesion reducing the mobility and generating the reported issue and additional failure.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: 25379737
• Report Number: 2124215-2026-29758
• Device Sequence Number: 13092516
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: 08714729185871
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 06/03/2026

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 Expiration Date: 05/13/2026
• Device Model Number: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 0034025087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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 Sex: Unknown