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

Model Number	GUIDEWIRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
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, an amplatzer guidewire was chosen for use during procedure.The guidewire was inspected prior to procedure and was flushed in loop prior to advancing, and it was barely noted that the distal part of the guidewire appeared to have partial uneven coating.Once the guidewire was placed, the balloon was advanced.During advancing of the balloon, part of the guidewire caused a dissection of the balloon.The device was replaced with a non-abbott guidewire, and the procedure was successfully completed.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 uneven coating on the distal part of guidewire and part of the guidewire causing a dissection of the balloon was reported.The guidewire returned coiled in a circular shape.A visual and microscopic examination of the returned product was completed, and the following features were observed.The returned guidewire had multiple bends and offsets present.This guidewire is a 3 - piece construction: coil, core and ribbon.The proximal end of the guidewire was sheared through the core, coil, and ribbon at the same location.The welded tip was not returned.The length of the guidewire returned was 204.5 cm.Approximately 55.5 cm of the proximal end was not returned.A microscopic examination of the core, coil, and ribbon reveled the guidewire was fracture sheared at the one point.The fracture occurred most likely with some form of intervention with a sharp metal object.The coil was stretched and offset from the fracture point indicating additional force was applied.No anomalies were observed to indicate a manufacturing issue with the distal weld.Fingerpull test was performed on the ribbon wire to confirm it was welded into the distal joint.It was also noted approximately 53 cm from the sheared point there was a large offset present, with the coating disturbed.No other damage was noted on the returned guidewire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Two images from field appeared to show a guidewire advanced through balloon.The guidewire appeared bent towards the distal end.The cause of reported incident could not be conclusively determined.
Event or Problem Description
N/a.

• 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: 17336830
• Report Number: 2135147-2023-03056
• Device Sequence Number: 6608261
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: 00811806010724
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 09/29/2023

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: 9941971
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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: UNKNOWN BALLOON
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 64 KG