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

Model Number	9-TV45X45-14F-080
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of delivery system difficult to advance through patient anatomy, pleural effusion and patient death was reported.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 all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
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.
Event or Problem Description
It was reported on (b)(6) 2025, two 14f delivery systems were chosen to be used in the procedure.Delivery sheath and pigtail catheter were positioned at the ostium of the appendage.The first rau/cranial fluoroscopic shot was completed.As the team prepared to obtain the rau/caudal shot, the patient¿s pressures became soft.The procedure was immediately stopped, and the delivery sheath and pigtail catheter were removed from the left atrium.Chest compressions were initiated.A pleural effusion was identified and was assessed as not related to the procedure.The compressions were reported to have worsened the effusion, and the patient¿s pressures did not recover.The physician stated that they did not believe the products used contributed to the event.
Event or Problem Description
It was reported on 22 december 2025, two 14f delivery systems were chosen to be used in the procedure during the case.One torqvue sheath was initially used, and a second torqvue sheath was subsequently introduced after placement of an outer sheath due to the tortuous vein.The delivery sheath and pigtail catheter were positioned at the ostium of the appendage.The first rau/cranial fluoroscopic image was obtained.As the team prepared to acquire the rau/caudal image, the patient¿s blood pressure became soft.The procedure was stopped immediately, and the delivery sheath and pigtail catheter were removed from the left atrium.Chest compressions were initiated.A pleural effusion was identified intraprocedurally once chest compressions began, and this effusion was assessed as not related to the procedure or the abbott devices.The compressions were reported to have worsened the effusion, and the patient¿s pressures did not recover.The pleural effusion could not be resolved, as the patient never became stable enough for intervention.Imaging confirmed the effusion during resuscitative efforts.The patient ultimately expired on (b)(6) 2025, with the cause of death documented as pleural effusion.The patient had been ambulatory and alert prior to the implant attempt, and the implanter classified the death as being related to the patient¿s comorbidities rather than the performance of the implanted device.Both abbott delivery sheaths were reported to have functioned as intended, and the implanter did not believe an abbott device contributed to the event.It was confirmed later that the occluder never made contact with the patient and the two delivery systems were used as the patient¿s venous anatomy was tortuous and the doctor deemed it necessary to use an outer sheath to help with that after the first delivery sheath was attempted.The physician removed the first delivery sheath as he could not pass the sheath and used a second delivery sheath after placing an outer sheath.It was also confirmed that the patient passed away in the cath lab prior to an abbott occluder device being introduced.
Additional Manufacturer Narrative
Additional information received indicating that the delivery system used was working as intended and that the death is not attributable to the device.Upon review, this amplatzer torqvue 45x45 lot number: 10943916 should not have been submitted as a medical device report (mdr).This event is captured under 2135147-2026-00374.

• 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: 24122413
• Report Number: 2135147-2026-00375
• Device Sequence Number: 9515829
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)280630(10)10943916
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 10943916
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 02/20/2026; 03/24/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/20/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male