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

Catalog Number DS-TV45X45-12F-080

Device Problems Product Quality Problem (1506); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that a 12f amplatzer torqvue 45x45 delivery sheath was selected for a procedure on (b)(6) 2024.During the procedure it was noted that the delivery sheath was kinked upon product box opening and looked as though there were three angulations instead of two.The decision was made to use the delivery sheath because it was uncertain if it truly was kinked.After inserting the device into the patient, it was noted that the device could not advance.The device was removed from the patient and replaced with a new 12f amplatzer torqvue 45x45 delivery sheath.Upon removal of the device it was confirmed that the sheath was kinked and the dilator tip was split into two.There were no adverse effects to the patient.The patient status 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 kink in sheath and split in tip of dilator was reported.Two images from field appeared to show tip of dilator deformed damaged marked with a blue arrow.Blood was seen on the tip of sheath through which the dilator tip was passed.Two other images from field appeared to show a sheath placed on operating table, the sheath appeared curved.The exact cause of the reported incident could not be conclusively determined.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.

• 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: 19044771
• MDR Text Key: 339433916
• Report Number: 2135147-2024-01552
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 05/30/2024

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-TV45X45-12F-080
• Device Lot Number: 8817511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2022
• 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