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

Catalog Number 9-TV45X45-14F-080

Device Problems Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 14f amplatzer torqvue 45x45 delivery sheath was chosen for procedure.During procedure, when the sheath was introduced to the patient over a 0.035 inch non-abbott guidewire, it was noted that the dilator had torn at the tip.The damaged sheath was introduced to the patient.A new 14f amplatzer torqvue 45x45 delivery sheath was used.There was delay in the procedure but no hemodynamic compromise or serious injury.There was no reported adverse patient effects.The patient was stable.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of dilator tip torn while introducing the sheath into the patient was reported.It was reported that the torn tip was noted when the sheath was introduced to the patient over a 0.035 inch non-abbott guidewire.The device was returned to abbott for investigation and the tip of dilator was noted split.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Abbott is performing further investigation to monitor this issue.H6 medical device problem code: code 2017 removed.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Type of Device: 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: 18074909
• MDR Text Key: 327423912
• Report Number: 2135147-2023-04881
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: 05415067025906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 8972651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female