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); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that core wire detachment occurred.The patient presented with peripheral artery disease (pad).A 035/180 (bx/1) magic torque guidewire was selected for use.Upon unpacking the device, the wire tip seemed to feel 'really floppy' in the words of the physician.The physician stated that "it's like the core of the wire and the outer layer of the wire are disconnected." the procedure was completed using alternate method or device.There were no patient complications reported.
Event or Problem Description
It was reported that core wire detachment occurred.The patient presented with peripheral artery disease (pad).A 035/180 (bx/1) magic torque guidewire was selected for use.Upon unpacking the device, the wire tip seemed to feel 'really floppy' in the words of the physician.The physician stated that "it's like the core of the wire and the outer layer of the wire are disconnected." the procedure was completed using alternate method or device.There were no patient complications reported.It was further reported that the guidewire was not detached and was not unravelled or come apart.The physician stated that the guidewire tip was just too floppy like in the core of the wire something may have been detached.
Additional Manufacturer Narrative
Device evaluated mfr.: unit returned with its original pouch batch overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was carefully inspected and no issues had been noted.However, during tactile inspection it was noted an anomaly in the inner core wire and solder bald weld.All the outer diameter measurements are within the specifications as per the document.During x-ray inspections it was confirmed that the core wire was separated form the distal tip section.
Additional Manufacturer Narrative
Correction: g2 report source - removed foreign and distributor/importer updated b5: describe event or problem updated h6: added material deformation.
Event or Problem Description
It was reported that core wire detachment occurred.The patient presented with peripheral artery disease (pad).A 035/180 (bx/1) magic torque guidewire was selected for use.Upon unpacking the device, the wire tip seemed to feel 'really floppy' in the words of the physician.The physician stated that "it's like the core of the wire and the outer layer of the wire are disconnected." the procedure was completed using alternate method or device.There were no patient complications reported.It was further reported that the guidewire was not detached and was not unravelled or come apart.The physician stated that the guidewire tip was just too floppy like in the core of the wire something may have been detached.

• 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: 15184185
• Report Number: 2124215-2022-29027
• Device Sequence Number: 6390414
• Product Code: DQX
• UDI-Device Identifier: 08714729741411
• UDI-Public: 08714729741411
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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: 0029358425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 09/07/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 08/19/2022; 09/28/2022
• 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 Sex: Unknown