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

Model Number	9-TV45X45-14F-080
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after the transeptal puncture a resistance was met advancing the amulet delivery sheath; the wire appeared to be kinked at the tip of the dilator.The tip of the dilator was reported to have split.The dilator and sheath were returned to abbott and the investigation found that the dilator tip was damaged split.No other anomalies were found.The returned sheath met the dimensional and functional specifications when analyzed using test amulet device.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; therefore, an exception was initiated to further investigate this complaint.The primary root cause was related to the potential for the raw material to not homogeneously blend during the melt processing.This potential cause relating to the material characteristics of this material is the root cause of both the noted cracking and tearing.The cause of reported advancement difficulty could not be determined.There were no complaints associated with any other devices from the lot.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 14f amplatzer torqvue 45x45 delivery sheath was chosen for a procedure.During the sheath exchange after the transeptal puncture a resistance was met advancing the amulet delivery sheath.When visualized under fluoroscopy, the wire appeared to be kinked at the tip of the dilator.When the sheath was removed it was found that the tip of the dilator had split.A 18f non-abbott sheath was placed into the venotomy and a new 14f amplatzer amulet delivery sheath was opened.The patient experienced no hemodynamic instability during the case.On (b)(6) 2025, the patient had been readmitted to the hospital with a cerebrovascular accident (cva).

• 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: 22591724
• Report Number: 2135147-2025-04069
• Device Sequence Number: 21120743
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)280331(10)10812991
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/28/2025

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: 10812991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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 Age: 68 YR
• Patient Sex: Male