MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TV45X45-14F-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm amplatzer amulet was chosen for implant using an 14f amplatzer torqvue delivery sheath.Internal jugular vein access was obtained, and a transseptal puncture was performed to access the left atrium.Following the puncture, a pericardial effusion was identified, and pericardiocentesis was carried out to manage the effusion.The physician elected to proceed with implantation of an amulet device.The device was introduced; however, deployment was not achieved due to lack of coaxial alignment, and the device was subsequently removed.The delivery sheath was exchanged for a steerable sheath and reinserted.During this process, the patient experienced a significant drop in blood pressure and developed pulseless electrical activity (pea).The delivery system was removed, and chest compressions were initiated.The patient stabilized following resuscitative measures.Per physician assessment, the complication was not attributed to the amulet device.No device was implanted in the left atrial appendage (laa).The patient is reported to be stable.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of circumferential pericardial effusion, low blood pressure and cardiac arrest was reported.Field indicated that there were multiple manipulations during the procedure due to challenging trajectory.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.It is possible that the operational difficulties may have contributed to reported patients.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The unexpected medical interferences were result of case-specific circumstances as pericardiocentesis was performed due to pericardial effusion and chest compressions were initiated due to pulseless electrical activity.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• 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: 23729851
• Report Number: 2135147-2025-07199
• Device Sequence Number: 18579567
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)280531(10)10895098
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• 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
• Report Date (Section B): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 10895098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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: 25MM AMPLATZER AMULET.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female