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

Model Number	39815
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch (b)(4) that the patient experienced pain and guidewire fracture occurred.Patient was in for elective cardiac catheterization with primary access at the radial artery.Copious amounts of arterial nitroglycerin were administered, however, despite this the physician was unable to navigate a 5fr non-boston scientific (bsc) guide catheter into the subclavian due to significant pain and spasm.So, the site was changed to a femoral approach.When the physician was attempting to remove the 5fr catheter and a 035/180 magic torque guidewire, the patient had significant pain which prompted further arterial spasm.More nitroglycerin was administered intra-arterially to ameliorate spasm, however, the magic torque wire was partially fractured, and a small amount of wire was left in the distal radial artery.Compression was obtained with a non-bsc compression device.Patient was evaluated post procedure and brisk radial pulse with a small hematoma that was stable, and the hand was neurovascular intact.
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14580305
• Report Number: 2134265-2022-05607
• Device Sequence Number: 19347394
• Product Code: DQX
• UDI-Device Identifier: 08714729741411
• UDI-Public: 08714729741411
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2024
• Device Model Number: 39815
• Device Catalogue Number: 39815
• Device Lot Number: 0027847802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 36 KG
• Patient Race: White