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

Model Number	9-GW-002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
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, a 08f amplatzer trevisio intravascular delivery system was chosen for the procedure.During advancement of the occluder through the delivery system, great resistance was met inside the delivery system, as if something was blocking the passage of the prosthesis.A replacement 08f amplatzer trevisio intravascular delivery system was used to complete the procedure.In addition to this incident with the delivery system, it was indicated that the physician felt great roughness in the material of the amplatzer guidewire used.Portions of small wrinkles were observed on the guidewire after removal.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Event or Problem Description
It was reported that on (b)(6) 2024, a 17mm amplatzer septal occluder was chosen for implant, using 08f amplatzer trevisio intravascular delivery system.During advancement of the occluder through the delivery system, great resistance was met inside the delivery system, as if something was blocking the passage of the prosthesis.A replacement 08f amplatzer trevisio intravascular delivery system was used to complete the procedure.In addition to this incident with the delivery system, it was indicated that the physician felt great roughness in the material of the used amplatzer guidewire during preparation.The device was used with no further issues.However, portions of small wrinkles were observed on the guidewire after removal.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 material deformation (roughness/small wrinkle) of the guidewire 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Additional Manufacturer Narrative
An event of material deformation (roughness/small wrinkle) of the guidewire was confirmed.The returned guidewire appeared to exhibit what resembled coating damage (roughness); however, upon inspection, the observation was found to be within specifications.The device history record was reviewed to ensure that all manufacturing and inspection operations were completed and that the product met all required specifications.Based on the information received and returned device analysis, the reported material deformation (guidewire roughness) was found to be within specification and showed no signs of a manufacturing defect or anomaly that could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4114 device not returned.Investigation findings: 3221 no findings available.

• 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: 18678334
• Report Number: 2135147-2024-00596
• Device Sequence Number: 7216833
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2025

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 Model Number: 9-GW-002
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 03/29/2024; 07/12/2025
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/03/2024; 07/17/2025
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 60 KG