MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE LP; CATHETER, PERCUTANEOUS

Model Number	9-TVLP4F90/080
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 01 july 2025, a 4f amplatzer torqvue lp delivery system was chosen for a patent ductus arteriosus (pda) closure procedure.During procedure, while crossing the pda, it was noted that the delivery sheath was kinked.The patient had a cardiac arrest and immediately resuscitated.The physician believed the kinked sheath caused the cardiac arrest.A new 4f amplatzer torqvue lp delivery system was chosen and completed the procedure.The patient was reported stable.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of cardiac arrest and delivery sheath kinked during procedure was reported.Field indicated that the patient had a cardiac arrest and immediately resuscitated.Abbott requested for images of device/operative notes to review, this was not provided by the field.A returned device assessment 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 specifications, including inspection for kinks and cracks.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
An event of cardiac arrest and delivery sheath kinked during procedure was reported.The device was returned and the delivery sheath was kinked.Field indicated that the patient had a cardiac arrest and immediately resuscitated.Abbott requested for images of device/operative notes to review, this was not provided by the field.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications, including inspection for kinks and cracks.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TORQVUE LP
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 22592088
• Report Number: 2135147-2025-04074
• Device Sequence Number: 8995760
• Product Code: DQY
• UDI-Device Identifier: 00811806011578
• UDI-Public: (01)00811806011578(17)270831(10)10522099
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-TVLP4F90/080
• Device Catalogue Number: 9-TVLP4F90/080
• Device Lot Number: 10522099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 12/19/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/15/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Unknown