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

Model Number	39815
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire tip sheared.The target lesion was located in the superficial femoral artery.A 035/260 magic torque guidewire was advanced to cross the lesion.However, it was noted that the tip was sheared.The tip was removed and the procedure was completed with another magic torque guide wire.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that guidewire tip sheared.The target lesion was located in the superficial femoral artery.A 035/260 magic torque guidewire was advanced to cross the lesion.However, it was noted that the tip was sheared.The tip was removed and the procedure was completed with another magic torque guide wire.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The returned device has the distal tip bent and damaged (stretched).All the outer diameter measurements are within the specifications.

• Brand Name: MAGIC TORQUE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8879175
• Report Number: 2134265-2019-09484
• Device Sequence Number: 243030
• Product Code: DQX
• UDI-Device Identifier: 08714729741428
• UDI-Public: 08714729741428
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 05/27/2022
• Device Model Number: 39815
• Device Catalogue Number: 39815
• Device Lot Number: 0023863073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1