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

Model Number	9-TV45X45-14F-080
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
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 that on 23 may 2025, a 14f amplatzer torqvue delivery system (ds) was selected for use in an implant procedure.After the device was being introduced, the dilator had become split.A new 14f amplatzer torqvue ds was used to complete the procedure.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.There were no adverse consequences to the patient.The patient is stable.
Additional Manufacturer Narrative
It was reported that the dilator had become split upon introducing the device.The dilator and sheath were returned to abbott and the investigation found that the tip of dilator was damaged.No other anomalies were found.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 investigation findings, the dilator tip separation issue appears to be related to a potential product quality issue; the issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
Event or Problem Description
It was reported that on (b)(6) 2025, a 14f amplatzer torqvue delivery system (ds) was selected for use in an implant procedure.After the device was being introduced, the dilator had become split.A new 14f amplatzer torqvue ds was used to complete the procedure.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.There were no adverse consequences to the patient.The patient is stable.

• 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: 22241510
• Report Number: 2135147-2025-03266
• Device Sequence Number: 8185768
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)271231(10)10686359
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/15/2025

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 Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 10686359
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Patient Sex: Male