MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GUIDEWIRE
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 1.5 mm modified j-tipfixed body amplatzer guidewire was chosen for a mitraclip implant procedure.It was reported the transseptal puncture was performed in the interatrial septum without complication.The 1.5mm guidewire was placed in the left superior pulmonary vein and the mitraclip g4 steerable guide catheter was advanced per instructions for use (ifu).When the dilator was retracted and the 1.5mm guidewire was to be placed inside to make the exchange with the mitraclip g4 clip delivery system, it was noted there was a kink observed at the tip of the guidewire.It was reported when the physicians pulled on the guidewire, they experienced difficulty in moving, turning, or retracting the guidewire.It was then reported a non-abbott guide liner was inserted to provide extra support, injected contrast, and the guidewire was retracted by pulling with force.A second contrast injection confirmed there was no damage to the patient and no need for further treatment.The rest of the procedure was performed without further complications and there was no report of any clinical significant delay in the procedure.The patient remained hemodynamically stable throughout the procedure and their status was reported as stable.
Additional Manufacturer Narrative
An event of difficulty while attempting to remove a guidewire anchored in the left superior pulmonary vein was reported.The investigation confirmed that the tip was bent and coils were displaced.Foreign material was noted on the tip and precluded functional testing due to the damage.Field indicated that a non-abbott guide liner was inserted to provide extra support, injected contrast, and the guidewire was retracted by pulling with force which may have cause damage to the guidewire.Few images from the field appeared to show deformed tip of the guidewire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.How or when the guidewire damage occurred could not be conclusively determined.
Additional Manufacturer Narrative
An event of difficulty while attempting to remove a guidewire anchored in the left superior pulmonary vein was reported.The investigation confirmed multiple offsets, stretched coils and body bends were present on the returned guidewire.Two sections of stretched coil were noted approximately 110cm and 113cm from the distal joint, the stretched coil was approximately 4.5cm and 5cm in length.The 1.5 mm j-shape was open upon return and there was foreign matter noticed on the distal tip.A fingerpull test was performed and the distal weld was intact.Information from the field indicated that a non-abbott guide liner was inserted to provide extra support, injected contrast, and the guidewire was retracted by pulling with force which may have cause damage to the guidewire.Few images from the field appeared to show deformed tip of the guidewire and observed that blue fiber was lodged between the second and third coil wraps on the distal end.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of guidewire damage occurred could not be conclusively determined.However, ¿excessive force used¿, and/or ¿improper use¿, may have impacted on the event as reported.

• Brand Name: AMPLATZER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16714602
• Report Number: 2135147-2023-01577
• Device Sequence Number: 7263997
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: 00811806010724
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K053187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2023

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 Model Number: GUIDEWIRE
• Device Catalogue Number: 9-GW-002
• Device Lot Number: 9941966
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 06/09/2023; 10/02/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/14/2023; 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER, GUIDELINE 5.5; MITRACLIP G4 CLIP DS, PART#: CDS0702-XTW; MITRACLIP G4 STEERABLE GUIDE, PART#: SGC0702
• Patient Age: 73 YR
• Patient Sex: Male