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

Catalog Number	9-GW-002
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an amplatzer guidewire was selected for a procedure on (b)(6) 2024.During the procedure while removing the guidewire from the 18mm amplatzer sizing balloon ii, it was believed that a blood clot was noted attached to the wire on intracardiac echocardiography (ice).There was some difficulty removing the guidewire from the balloon.Upon separation it was noted that there was no clot but the guidewire was observed to have a strand of wire sticking out from the side.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of stuck guidewire inside a sizing balloon and material deformation was reported.The device was returned for investigation and confirmed to meet dimensional specification.The guidewire had a fractured ribbon.The ribbon protruded through the coil approximately 2.5cm from the distal end.The coil and core remained intact.There are three bends present approximately 1cm and 3.4cm from the distal end, and 7cm from the proximal end.There was approximately 0.1cm of the fractured ribbon protruding from the back of the distal weld.There is evidence of necking on both sides of the ribbon fracture point, which would suggest that this fracture was due to tensile overload.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that an amplatzer guidewire was selected for a procedure on (b)(6) 2024.During the procedure while removing the guidewire from the 18mm amplatzer sizing balloon ii it was suspected that a blood clot was noted attached to the wire on intracardiac echocardiography (ice).There was some difficulty removing the guidewire from the balloon.Upon separation it was noted that there was no clot but the guidewire was observed to have a strand of wire sticking out from the side.The patient did not present with any clinical signs or symptoms.The patient status was stable.

• 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: 21071233
• Report Number: 2135147-2025-00073
• Device Sequence Number: 8399216
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: (01)00811806010724(17)280930(10)9943927
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/03/2025

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 Catalogue Number: 9-GW-002
• Device Lot Number: 9943927
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: 18MM AMPL SIZING BALLOON [9-SB-018, LOT: 10084846].
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown