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

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Codes	Difficult to Insert (1316); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 12f amplatzer torqvue 45x45 delivery sheath was selected for a procedure on (b)(6) 2025.The device was prepared per ifu.The delivery sheath was placed on the guidewire; however, it was noted that delivery sheath could not be inserted into the patient.Upon inspection the dilator was split.The delivery sheath was replaced with a new 12f amplatzer torqvue 45x45 delivery sheath.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
It was reported that a split in delivery sheath dilator noted during procedure was reported.There were no adverse effects to the patient and the patient status was reported as stable.The dilator and sheath were returned to abbott and the investigation found that the tip of the dilator was noted to have a split cut damage.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; therefore, an exception was initiated to further investigate this complaint.The primary root cause was related to the potential for medium density polyethylene and pebax to not homogeneously blend during melt processing.This potential relating to the material characteristics of the resin mix 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: 21276275
• Report Number: 2135147-2025-00466
• Device Sequence Number: 19748877
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)270228(10)10231670
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/19/2025

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 Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 10231670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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
• Patient Sex: Unknown