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

Model Number	9-GW-002
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, an amplatzer guidewire was chosen for procedure.During the procedure, there was unusual resistance when trying to pass the wire through the introducer.The decision was made to proceed with using the wire.Upon introducing the 18mm amplatzer sizing balloon ii, resistance was felt when advancing the balloon, and the wire began to show signs of entanglement.When the balloon was about to be removed, the situation worsened, and the wire started to tangle and show signs of wear with the nylon fraying and forming a bundle of fibers.The wire was removed and replaced with another amplatzer guidewire.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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 difficult to advancing and fracture 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.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.
Event or Problem Description
It was reported that on (b)(6) 2024, an amplatzer guidewire was chosen for procedure.There were no issues with the product packaging.There were no problems noted during device preparation.During the procedure, there was unusual resistance when trying to pass the wire through the introducer.The decision was made to proceed with using the wire.Upon introducing the 18mm amplatzer sizing balloon ii, resistance was felt when advancing the balloon, and the wire began to show signs of entanglement.When the balloon was about to be removed, the situation worsened, and the wire started to tangle and show signs of wear with the nylon fraying and forming a bundle of fibers.The wire was removed and replaced with another amplatzer guidewire.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 difficult to advancing and fracture was reported.The reported difficult to advancing could not be replicated in a testing environment due to the returned conditions of the device (bent wire and uncoiled wire).The reported fracture wire did not confirmed.Additionally, it was observed that the wire was bent.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the cause of the reported difficult to advancing and fracture could not be conclusively determined.The observed bent wire appears to be related to post-procedural handling.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 chosen for procedure.There were no issues with the product packaging.There were no problems noted during device preparation.During the procedure, there was unusual resistance when trying to pass the wire through the introducer.The decision was made to proceed with using the wire.Upon introducing the 18mm amplatzer sizing balloon ii, resistance was felt when advancing the balloon, and the wire began to show signs of entanglement.When the balloon was about to be removed, the situation worsened, and the wire started to tangle and show signs of wear with the nylon fraying and forming a bundle of fibers.The wire was removed and replaced with another amplatzer guidewire.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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: 20796183
• Report Number: 2135147-2024-06047
• Device Sequence Number: 12736200
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: (01)00811806010724(17)280630(10)9943931
• 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): 03/26/2025

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: 9943931
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 03/24/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/27/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: AMPLATZER SIZING BALLOON II, 9-SB-018
• Patient Sex: Unknown