MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BACK-UP MEIER; WIRE, GUIDE, CATHETER

Model Number	41488
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating unraveled.Two 0.035in, 185cm, j tip back-up meier guidewires were used in a tavr procedure.While advancing the guidewire through the sheath, the guidewire's coating unraveled.This occurred on both devices.A non-boston scientific guidewire was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Media analysis by manufacturer: the customer provided a picture.Per media inspection, it can be observed that the ptfe of the guidewire was peeled off.
Additional Manufacturer Narrative
Media analysis by manufacturer: the customer provided a picture.Per media inspection, it can be observed that the ptfe of the guidewire was peeled off.Device eval by manufacturer: the returned guidewire was bent/kinked at the distal end.Additionally, visual and microscopic inspection revealed that the coating ptfe was peeled off at several sections.
Event or Problem Description
It was reported that the coating unraveled.Two 0.035in, 185cm, j tip back-up meier guidewires were used in a tavr procedure.While advancing the guidewire through the sheath, the guidewire's coating unraveled.This occurred on both devices.A non-boston scientific guidewire was used to complete the procedure.No patient complications were reported.

• Brand Name: BACK-UP MEIER
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15161532
• Report Number: 2124215-2022-28835
• Device Sequence Number: 5464080
• Product Code: DQX
• UDI-Device Identifier: 08714729227885
• UDI-Public: 08714729227885
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K020283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 02/02/2024
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0028794522
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male