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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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
(b)(4) - veritas study, patient site id: (b)(6).It was reported on (b)(6) 2025 a 14f amplatzer torqvue 45x45 delivery sheath was selected for a procedure.During the procedure it was noted that the dilator of the delivery sheath split while advancing the delivery sheath through the non-abbott guidewire that had kinked.The delivery sheath was removed from the patient and replaced with a new 14f amplatzer torqvue 45x45 delivery sheath.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays to the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
It was reported that during the procedure the dilator split while advancing the delivery sheath through the non-abbott guidewire that had kinked.The dilator and sheath were returned to abbott and the investigation found that there was a damaged split noted at the tip of the dilator.No other anomalies were found.The returned sheath met the dimensional and functional specifications when analyzed using test amulet device.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.

• 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: 22338418
• Report Number: 2135147-2025-03435
• Device Sequence Number: 18407100
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)270831(10)10534521
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 10534521
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN NON-ABBOTT GUIDEWIRE.
• Patient Sex: Unknown