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	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6).Date of event: used (b)(6) 2019 since exact date was not provided.
Event or Problem Description
It was reported that the wire fractured.A gw/035/260 magic torque guide wire was selected for use.However, during procedure, it was noted that the wire sheared.The wire was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Date of event - used (b)(6) 2019 since exact date was not provided.
Event or Problem Description
It was reported that the wire fractured.A gw/035/260 magic torque guide wire was selected for use.However, during procedure, it was noted that the wire sheared.The wire was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.It was further reported that about 85-90% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.There was no coating left inside the patient's body.The physician noticed the shearing of the device right after it was normally removed from the patient.

• 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: 8879140
• Report Number: 2134265-2019-09509
• Device Sequence Number: 13513708
• 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): 09/12/2019

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: 05/12/2022
• Device Model Number: 39815
• Device Catalogue Number: 39815
• Device Lot Number: 0023780787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR