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

Model Number	3600
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	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a wire fracture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A rotawire was selected for use.During the procedure, it was noted that the wire fractured into two pieces.The device was removed completely from the patient.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
Event or Problem Description
It was reported that a wire fracture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A rotawire was selected for use.During the procedure, it was noted that the wire fractured into two pieces.The device was removed completely from the patient.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual and microscope inspection on spring tip was observed bent.The mid-section of the guidewire was detached and did not return for analysis.Dimensional inspection revealed that the 78.5 in of mid-section of the guidewire was detached and did not return for analysis.Based on the evidence, the as reported code of 'guidewire detachment of device or device component' can be confirmed due to the observed detachment of the mid-section of the guidewire.The bent on the spring tip did not contribute 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20081267
• Report Number: 2124215-2024-52069
• Device Sequence Number: 20749174
• Product Code: MCX
• UDI-Device Identifier: 08714729195573
• UDI-Public: 08714729195573
• 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): 11/22/2024

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: 10/26/2025
• Device Model Number: 3600
• Device Catalogue Number: 3600
• Device Lot Number: 0032738672
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 60 KG