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

Model Number	3560
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	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotawire detached.A rotawire was selected for a percutaneous coronary intervention (pci).During the procedure, it was noted that the wire broke into two pieces.No complications were reported and the patient was stable.
Event or Problem Description
It was reported that the rotawire detached.A rotawire was selected for a percutaneous coronary intervention (pci).During the procedure, it was noted that the wire broke into two pieces.No complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual inspection revealed that the body of the guidewire was kinked and detached.A microscopic inspection revealed that the spring tip was observed bent.The detachment of the guidewire was at a distance of 140 cm.The reported event of detachment was confirmed.

• 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 DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18619492
• Report Number: 2124215-2024-04396
• Device Sequence Number: 2441567
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 04/08/2024

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: 05/17/2024
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0029423713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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