MAUDE Adverse Event Report: ABBOTT MEDICAL DO NOT USE; CATHETER, PERCUTANEOUS

Catalog Number 9-ITV05F180/60

Device Problems Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6)2024, a 5-4mm amplatzer duct occluder i was chosen for implantation utilizing a a 5f amplatzer torqvue delivery system.During preparation, the duct occluder had trouble advancing from the loader to the sheath.After multiple attempts to place the device, it was decided to recapture the occluder.When attempting to recapture the occluder into the delivery system, it would only recapture the waist of the device, but not the disc.The delivery system had to be removed while the occluder was still deployed at the end.A significant amount of time was added to the case but the patient remained hemodynamically stable throughout the procedure.There was no vessel or tissue damage.The patient remained stable.

• Brand Name: DO NOT USE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18739905
• MDR Text Key: 336286558
• Report Number: 2135147-2024-00748
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072313
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Catalogue Number: 9-ITV05F180/60
• Device Lot Number: 6756029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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: 5 MO
• Patient Sex: Female