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	12/04/2024
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) 2024, an amplatzer guidewire was used during a patent foramen ovale (pfo) procedure.During the procedure, the guidewire was attempted to be removed from the 6f catheter, but it would not slide out.The end of the wire had frayed, so the wire unable to be removed without removing all the wires and catheters.After the catheter was removed from the patient, the wire was unable to be removed from the catheter.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 stuck guide wire inside a 6f catheter was reported.The device was returned for investigation and confirmed to meet dimensional specification.The guidewire had offsets approximately 0.5 cm and 1 cm from the distal weld, and 0.3 cm and 2.2 cm from the proximal weld, with four open coils starting right at the proximal weld.Some coating damage was noted on the offsets 0.3 cm and 2.2 cm from the proximal weld.Microscopic examination of the guidewire¿s distal and proximal welds did not reveal any anomalies; both welds were intact.A finger-pull test was performed on the returned guidewire and passed.There was no fracture on the guidewire.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 on (b)(6) 2024, an amplatzer guidewire was used during a patent foramen ovale (pfo) procedure.During the procedure, the guidewire was attempted to be removed from the 6f catheter, but it would not slide out.The end of the wire had frayed, so the wire unable to be removed without removing all the wires and catheters.After the catheter was removed from the patient, the wire was unable to be removed from the catheter.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.

• 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: 21022061
• Report Number: 2135147-2024-06591
• Device Sequence Number: 4120342
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: (01)00811806010724(17)271031(10)9943110
• 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): 03/25/2025

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: 9943110
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male