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

Catalog Number DS-TV45X45-14F-080

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer amulet delivery sheath.During procedure, a kink was appeared on the delivery sheath, so it was not possible to fully retract the occluder into the sheath.Due to the kink there was not enough space for the screw hub to pass the kink and occluder could not be positioned in the right position.The physician confirmed the sheath was kinked due to patient anatomy and there was no deformation seen in the sheath during preparation.The device was removed in a partially opened position.The 28mm amulet was not implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

Manufacturer Narrative

An event of a kink appearing on a delivery system during procedure was reported.The device was returned to abbott for analysis and the investigation revealed numerous kinks on the delivery system that precluded functional testing.Information from the field indicated that the reported event was due to patient anatomy.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported could not conclusively be determined but appears to be due to patient anatomy.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18596859
• MDR Text Key: 334025454
• Report Number: 2135147-2024-00394
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 05415067028044
• UDI-Public: (01)05415067028044(17)250831(10)8665653
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: DS-TV45X45-14F-080
• Device Lot Number: 8665653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 04/13/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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