MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAGIC TORQUE; WIRE, GUIDE, CATHETER

Model Number	39815
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the tip of the guidewire unraveled.A 035/260 (bx/3) magic torque guidewire was advanced into the lesion.However, the tip of the guidewire unraveled while inside the patient.It was noted that this also happened in a separate case using another of same device.In both cases, the guidewire was removed from the patient and the procedure was successfully completed with good blood flow.No patient complications were reported.However, returned device analysis revealed a detached core wire.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned, and during the product analysis it was observed that the coil wire was unraveled and stretched, the core wire was detached/separated at the distal end section, and the distal tip kinked.The device was sent for material analysis and by sem inspection and confirms the fracture of the core wire.The reported event coil wire unraveled material is confirmed.

• Brand Name: MAGIC TORQUE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15715018
• Report Number: 2124215-2022-42022
• Device Sequence Number: 20497195
• Product Code: DQX
• UDI-Device Identifier: 08714729114628
• UDI-Public: 08714729114628
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K933334
• 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
• Report Date (Section B): 11/02/2022

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: 05/07/2025
• Device Model Number: 39815
• Device Catalogue Number: 39815
• Device Lot Number: 0029358427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2022
• 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: 71 YR
• Patient Sex: Male