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

Model Number	9-TV45X45-14F-080
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025 a 28mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During the procedure unidentified material was observed attached to the end of the delivery sheath while attempting to deploy the occluder.The occluder was removed from the patient and replaced with a new 28mm amplatzer amulet left atrial appendage occluder.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was 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
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
User facility medwatch report mw5176346 received that states "during a left atrial appendage occlusion procedure with an amulet device, suspected clot on the implant in the left atrium on transesophageal echocardiogram (tee).Successfully withdrew theimplant and sheath back across the atrial septum and out of the body.The system was inspected& the team and determined to have a fine, fibrous, white, wiry foreign object loosely attached to the implant (not a clot).The patient was heparinized and maintained a therapeutic act during this procedure.The implant was removed from the table & a new device was obtained." on (b)(6) 2025 a 28mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During the procedure unidentified material was observed attached to the end of the delivery sheath while attempting to deploy the occluder.The occluder was removed from the patient and replaced with a new 28mm amplatzer amulet left atrial appendage occluder.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was stable.
Event or Problem Description
User facility medwatch report mw5176346 received that states "during a left atrial appendage occlusion procedure with an amulet device, suspected clot on the implant in the left atrium on transesophageal echocardiogram (tee).Successfully withdrew theimplant and sheath back across the atrial septum and out of the body.The system was inspected& the team and determined to have a fine, fibrous, white, wiry foreign object loosely attached to the implant (not a clot).The patient was heparinized and maintained a therapeutic act during this procedure.The implant was removed from the table & a new device was obtained." on (b)(6) 2025 a 28mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During the procedure unidentified material was observed attached to the end of the delivery sheath while attempting to deploy the occluder.The occluder was removed from the patient and replaced with a new 28mm amplatzer amulet left atrial appendage occluder.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of foreign material (fiber) could not be confirmed.The device was returned to abbott for investigation and did not confirm the foreign material.The 13f loader and the 14f delivery sheath were noted to be kinked.The flush adapter had a twisted deformation on the tubing.No foreign material was found on the sheath or the occluder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information reviewed, the cause of the reported foreign material (fiber) could not be conclusively determined.The observed kink on the returned loader, sheath appears to be due to post procedural handling.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23224995
• Report Number: 2135147-2025-05689
• Device Sequence Number: 18502006
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)260731(10)9174506
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 9174506
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 12/08/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White