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

Model Number	GUIDEWIRE
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
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 14f amplatzer amulet delivery sheath was chosen for procedure.A 0.035 inch amplatzer guidewire was used to ease the insertion of the delivery sheath within the left atrium and the left upper pulmonary vein.Once the delivery sheath was in place in the left upper pulmonary vein, the dilator and guidewire were withdrawn together from the delivery sheath.Once on the table, the guidewire could not be removed from the dilator after two attempts without success.There appeared to be a kink in the distal tip of the guidewire, which was why the guidewire could not be removed from the dilator.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of difficulty in removing a guidewire from the dilator of the amplatzer amulet delivery sheath and the kink in the guidewire was reported.The guidewire was returned to abbott for investigation.The investigation confirmed that the returned guidewire was kinked and bent near the tip, and the inner core wire was stuck out and fractured.The guidewire was stuck inside the return dilator.No functional testing could be performed due to the damage.A review of receiving inspection results for this lot number confirmed that the product was manufactured according to specifications.How or when the guidewire damage occurred could not be conclusively determined.However, the reported retraction failure was due to the damaged guidewire.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.
Additional Manufacturer Narrative
An event of difficulty in removing a guidewire from the dilator of the amplatzer amulet delivery sheath and the kink in the guidewire was reported.The guidewire was returned to abbott for investigation.The investigation confirmed that the returned guidewire had multiple bends and offsets present, with the core protruding through the coil wraps at the point of an offset approximately 2.5 cm from the distal joint.The core was protruding out of the coil wraps approximately 4 mm.No anomalies were observed to indicate a manufacturing issue with the distal and proximal weld.Finger-pull test was performed on the distal and proximal joints and were confirmed to be intact.No other damage was noted on the returned guidewire.A dimensional check was performed to ensure critical guidewire dimensions were within supplier specification per guidewire drawing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all supplier specifications.How or when the guidewire damage occurred could not be conclusively determined, however the reported retraction failure was due to the damaged guidewire.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.Please note that per the instructions for use, "precautions: do not withdraw a ptfe coated guidewire through a metal-cannula needle.Withdrawal may damage the guidewire coating.If strong resistance is met during manipulation, discontinue the procedure, and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and the guidewire.

• 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: 17101070
• Report Number: 2135147-2023-02510
• Device Sequence Number: 19330008
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: 00811806010724
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/26/2023

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: 9941974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 10/03/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 06/20/2023; 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: AMPLATZER AMULET DS, DS-TV45X45-14F-080.
• Patient Age: 81 YR
• Patient Sex: Male