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

Model Number	39815
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire's coating has peeled.The 60% stenosed target lesion was located in the common/external iliac vein.A 035/260 (bx/3) magic torque guidewire was used.However, after the guidewire was removed from the patient's body, it was noticed that the coating was peeling off.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: this product was returned for analysis.The coating on the coil section is scratched (peeled) and the shrink sleeve is also peeled.The distal tip is bent.The outer diameter of proximal, middle of the device, and distal section are within specifications.
Event or Problem Description
It was reported that the guidewire's coating has peeled.The 60% stenosed target lesion was located in the common/external iliac vein.A 035/260 (bx/3) magic torque guidewire was used.However, after the guidewire was removed from the patient's body, it was noticed that the coating was peeling off.The procedure was completed with a different device.No patient complications were reported.

• 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: 11244438
• Report Number: 2134265-2021-00829
• Device Sequence Number: 19784781
• Product Code: DQX
• UDI-Device Identifier: 08714729114628
• UDI-Public: 08714729114628
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K933334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: 11/18/2023
• Device Model Number: 39815
• Device Catalogue Number: 39815
• Device Lot Number: 0026385401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1