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

Catalog Number DS-TV45X45-12F-080

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504); Difficult to Advance (2920); Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 03/21/2023

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 12f amplatzer amulet delivery sheath (lot 7826835) was chosen for procedure.The patient's access was very calcified.The transseptal puncture was performed.There was difficulty when the sheath was introduced into the patient and while advancing the device though the patient.It was discovered during advancement that the delivery system had a hole in it and was also kinked.The delivery sheath looked atypical and was removed from the patient.The device was replaced with another 12f amplatzer amulet delivery sheath (lot 7826835), and an attempt was made to implant a 25mm amplatzer amulet left atrial appendage occluder (lot 7822491), but it was unable to be positioned in the correct location in the left atrial appendage.The devices were replaced with a 14f amplatzer amulet delivery sheath (lot 8476935) and another 25mm amplatzer amulet left atrial appendage occluder (lot 7633347), but it was also unable to be implanted due to positioning.No device was implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient status was unknown.

Manufacturer Narrative

An event of resistance while advancing the device through the delivery system and delivery sheath being kinked was reported.The device was returned to abbott for investigation and found kinks throughout sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.The cause of the reported incident could not be conclusively determined.

• 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: 16727388
• MDR Text Key: 313163957
• Report Number: 2135147-2023-01594
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: DS-TV45X45-12F-080
• Device Lot Number: 7826835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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