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

Catalog Number DS-TV45X45-12F-080

Device Problems Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 25mm amplatzer amulet left atrial appendage occluder (8726339) was selected for implant using a 12f amplatzer amulet delivery sheath (8761678).During the procedure, the occluder was implanted into the left atrial appendage.Shortly before releasing the disc of the occluder, the sheath was pulled too far back.The sheath was twisted, and the device completely moved from out of the left atrial appendage.The occluder was in the left atrium, and the sheath was damaged.The occluder could no longer be re-sheathed due to the damaged delivery system, and the occluder was removed from the patient's anatomy using the sheath.Both devices were replaced with a 22mm amplatzer amulet left atrial appendage occluder (8738070) and a 12f amplatzer amulet delivery sheath (8761678).The 22mm amulet occluder was successfully implanted.The patient status was reported as stable and recovering.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

Manufacturer Narrative

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

Manufacturer Narrative

An event of damage to delivery system and occluder device could no longer be re-sheathed was reported.It was also reported that the sheath was pulled too far back before releasing the disc of occluder.The returned sheath was kinked and damaged through out which precluding functional testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.One photograph from field appeared to show a partially deployed lobe of occluder through an kinked sheath.There were two boxes indicating the twist on the sheath and causing difficulty passing the disc through narrow point.The cause of the reported event could not be conclusively determined, however is consistent with damage during use.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "warning: if the device needs to be retracted after this point, the device and sheath must both be removed and replaced.".

• 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: 16704001
• MDR Text Key: 313155515
• Report Number: 2135147-2023-01527
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DS-TV45X45-12F-080
• Device Lot Number: 8761678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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