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

Catalog Number	9-GW-002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
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 (9-gw-002) was chosen for the procedure.After removing the guidewire after implanting the occluder, a fracture was noted at the distal end of the guidewire (close to the j-tip) with exposed tips.There was no excessive manipulation of the guidewire during use.The guidewire was placed in the left superior pulmonary vein without any difficulty.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of fracture was noted at the distal end of the guidewire with exposed tips was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.Imaging received appeared to show device deformation, which could not be confirmed without device return.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There was no evidence to suggest that the design of the guidewire or any manufacturing related concerns has contributed to the reported incident.The cause of reported incident could not be conclusively determined.However, based on the information provided, ¿improper use¿, and/or ¿excessive force used¿ may have impacted on the event as reported.
Additional Manufacturer Narrative
An event of fracture was noted at the distal end of the guidewire with exposed tips was reported.A visual and microscopic examination of the returned product was completed, and the following features were observed.Fingerpull test was performed on the returned guidewire confirming that the guidewire¿s joints were intact.No anomalies were observed to indicate a manufacturing issue with the distal weld or the proximal weld.There was no evidence of the guidewire being fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There was no evidence to suggest that the design of the guidewire or any manufacturing related concerns has contributed to the reported incident.The cause of reported incident could not be conclusively determined.However, based on the information provided, ¿improper use¿, and/or ¿excessive force used¿ may have impacted on the event as reported.
Event or Problem Description
It was reported that on (b)(6) 2024, an amplatzer guidewire (9-gw-002) was chosen for the procedure.After removing the guidewire after implanting the occluder, a fracture was noted at the distal end of the guidewire (close to the j-tip) with exposed tips.There was no excessive manipulation of the guidewire during use.The guidewire was placed in the left superior pulmonary vein without any difficulty.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• 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: 18714647
• Report Number: 2135147-2024-00701
• Device Sequence Number: 6309361
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: (01)00811806010724(17)280531(10)9943922
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2025

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: 9943922
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/28/2024; 02/25/2025
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/03/2024; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Female