MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Catalog Number	9-ITV05F180/60
Medical Device Problem Codes	Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Event or Problem Description
It was reported that on (b)(6) 2024, a 5-4mm amplatzer duct occluder i was chosen for implantation utilizing a a 5f a(mplatzer 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.
Additional Manufacturer Narrative
An event of difficult to advance, retraction problem, and positioning problem was reported.The device was received for investigation and no anomalies were found, with the device advancing and retracting a test valve under non-physiological conditions with ease.In addition, it was observed that the sheath was deformed and the loader was bent.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, a cause for the reported incidents could not be conclusively determined.The observe deformed sheath and kinked loader were due to post-procedural handling.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 2017 removed.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: 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: 18739905
• Report Number: 2135147-2024-00748
• Device Sequence Number: 20566362
• Product Code: DQY
• UDI-Device Identifier: 00811806010755
• UDI-Public: (01)00811806010755(17)250731(10)8619043
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 9-ITV05F180/60
• Device Lot Number: 8619043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Female