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

Model Number	9-TV45X45-14F-080
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	02/26/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for analysis.An event of difficult to advance through patient anatomy was reported.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 available information, the cause of the reported difficult to advance through patient anatomy could not be determined.The patient effects of cardiac arrest, hemorrhage, hematoma, and hypotension could not determined.Death was related to patient's comorbidities.The reported unexpected medical interventions were a result of case-specific circumstances.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) 2025, an amplatzer amulet left atrial appendage (laa) occluder was chosen for implantation utilizing a 14f torqvue 45x45 delivery sheath.During advancement of the delivery system, resistance was encountered and advancement was stopped.On fluoroscopy, the sheath was wrapped around itself and kinked so the delivery system was removed and replaced.A 18f groin sheath was placed and the replacement 14f torqvue 45x45 delivery system was advanced.The delivery system experienced resistance when trying to cross the septum.The delivery system was removed and the septum was dilated.The delivery system was then able to cross the septum and advanced to the laa.Blood pressure became unstable so the case was aborted.No effusion or groin complications were observed.Once patient was brought to the recovery area blood pressure dropped.A hematoma was noted in groin area.Manual compression was performed, and the patient coded and died.It is believed that the patient had a bleed at the groin site and entered cardiogenic shock due to a low ejection fraction.The cause of the bleed is unknown as an arterial line had also been inserted.
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.

• 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: 21654377
• Report Number: 2135147-2025-01440
• Device Sequence Number: 7480242
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)270930(10)10552309
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/06/2025

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: 10552309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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; Death
• Patient Age: 62 YR
• Patient Sex: Male