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

Model Number	39815
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire detachment occurred.The patient presented with peripheral artery disease (pad) and underwent peripheral angiogram.A gw/035/260 magic torque guidewire was selected for used.However, during the preparation, the floppy tip was noticed to be stretched upon removal from the coil, and the inner coil of the wire seemed to be detached from the tip.The procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned, and it was observed that the distal end section was kinked at several parts.No more visual damages were observed.Under microscope it was observed that the core wire was detached/separated near a ro marker.The outer diameter of distal tip, middle of the device, and the proximal section are within specifications.
Event or Problem Description
It was reported that guidewire detachment occurred.The patient presented with peripheral artery disease (pad) and underwent peripheral angiogram.A gw/035/260 magic torque guidewire was selected for used.However, during the preparation, the floppy tip was noticed to be stretched upon removal from the coil, and the inner coil of the wire seemed to be detached from the tip.The procedure was completed.There were no patient complications reported.

• 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: 15765074
• Report Number: 2124215-2022-43775
• Device Sequence Number: 20894592
• Product Code: DQX
• UDI-Device Identifier: 08714729741428
• UDI-Public: 08714729741428
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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): 12/22/2022

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: 06/17/2025
• Device Model Number: 39815
• Device Catalogue Number: 39815
• Device Lot Number: 0029614619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• 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 Sex: Unknown