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

Catalog Number DS-TV45X45-14F-080

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on 26 january 2024, a 14mm amulet delivery sheath was used for the procedure.Resistance was felt during insertion of the delivery sheath into the patient¿s anatomy.The delivery sheath was pushed with force and was advanced.However, once advanced, it was noticed in angiogram that there was a separation of the guidewire and the tip of the delivery sheath dilator.The delivery sheath was removed.It was observed outside the patient that the tip of the dilator was split.A replacement 14mm amulet delivery sheath was used to complete the procedure.There was no adverse patient effect.

Manufacturer Narrative

An event of tip of the dilator being split was reported.It was reported that there was resistance noted during insertion of the delivery sheath into the patient¿s anatomy.The investigation at abbott found that tip of dilator was deformed and damaged split.Information from field indicated that the delivery sheath was pushed with force and was advanced which may have contributed to the reported event.The cause of the reported incident could not be conclusively determined, however could possibly be related to the damage during use.Abbott is performing further investigation to monitor this issue.

• 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: 18739644
• MDR Text Key: 335762948
• Report Number: 2135147-2024-00743
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K163000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DS-TV45X45-14F-080
• Device Lot Number: 8755415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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