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); Material Split, Cut or Torn (4008)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 14f amplatzer torqvue 45x45 delivery sheath was chosen for the procedure.After the transseptal puncture, the delivery sheath was introduced in the patient.Once the sheath was in the left atrium, the dilator was removed from the patient.It was decided to perform another transseptal puncture for better approach to the left atrial appendage (laa).The delivery sheath was removed from the patient, and another transseptal puncture was performed.During re-insertion of the delivery sheath with the dilator, resistance was met in the access site.At this point, it was noted that the tip of the dilator was split into two parts.A replacement delivery sheath, same size, was used to complete the procedure.The patient was reported to be stable.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.Na.

Manufacturer Narrative

An event of tip of the dilator was split into two parts was reported.It was reported that there was resistance noted at the access site which may have contributed to the reported damage.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.An image from field appeared to show distal end of dilator having split tip.Based on the information received, the cause of the reported incident could not be conclusively determined.Abbott is performing further investigation to monitor this issue.

Manufacturer Narrative

An event of tip of the dilator was split into two parts was reported.The dilator was returned to abbott and found to be deformed and damaged split at the tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.An image from field appeared to show distal end of dilator having split tip.The cause of the reported incident could not be conclusively determined.Abbott is performing further investigation to monitor this issue.Na.

• 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: 17791836
• MDR Text Key: 323969842
• Report Number: 2135147-2023-04122
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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: 8871446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male