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

Catalog Number 9-TV45X45-14F-080

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/11/2023

Event Type  Injury  

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 14f amplatzer torqvue 45x45 delivery sheath was chosen for the procedure.Following the trans-septal puncture, a 0.025-inch non-abbott pigtail wire was placed across the septum for exchange of the 14f amulet torqvue sheath.Great resistance on the delivery system was felt at the groin site while initially advancing.The physician attempted to advance multiple times with varying amounts of force.Eventually, the tip of the dilator was noted to split in two to the level of the sheath tip.The system was backed off the wire and inspected, there was no concern for missing pieces of the dilator tip.This resistance was not felt while advancing the transseptal sheath earlier and no concern for tortuosity was warranted before attempting to place the delivery system.After damaged sheath was removed, the patient was noted to be bleeding at the groin access site.Manual pressure was used at the groin site until an 18f non-abbott introducer sheath was introduced.A new 14f amplatzer torqvue 45x45 delivery sheath was telescoped through the 18f non-abbott introducer sheath and the procedure was successfully completed.The patient was reported to be stable and discharged.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 difficulty advancing the delivery system and split in tip of dilator was reported.It was also reported that the patient was bleeding at the groin access site after removal of delivery system that was addressed through manual pressure until a new sheath was introduced.Information from field indicated that the bleeding was due to the time spent removing and inserting a new sheath.Field also indicated that multiple attempts were made to advance delivery system through resistance which may have contributed to the damaged dilator tip.The investigation found the tip of dilator was split when analyzed at abbott under non-physiological conditions.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 spit at the tip of dilator could not be conclusively determined.As a result of this finding, abbott is performing further investigation to monitor this issue.

Event Description

N/a.

• 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: 18051669
• MDR Text Key: 327126992
• Report Number: 2135147-2023-04812
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: 05415067025906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 8874854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 79 KG