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

Catalog Number	9-ITV06F180/80
Medical Device Problem Codes	Material Invagination (1336); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
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 28 march 2024, a 5mm amplatzer duct occluder was chosen for implantation utilizing a 6f amplatzer torqvue delivery system (9-itv06f180/80 lot: 8979325).During implantation a re-sheath was attempted to re-optimize positioning, however the occluder could not be fully retracted.The sheath tip was observed to be invaginated.The delivery system and occluder were removed from the patient without being fully re-sheathed.No surgical intervention was necessary.A replacement amplatzer torqvue ( 9-tvlp5f90/080 lot 8435188) and amplatzer duct occluder ii (9-pda2-05-04 lot 8719681) was used to complete the procedure successfully.There were no patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.
Additional Manufacturer Narrative
An event of retraction problem and invaginated catheter tip was reported.The device was returned to abbott for investigation.The returned sheath was visually examined, and the sheath tip was noted to be invaginated.The returned sheath, delivery cable, and occluder were measured and met dimensional specifications.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 reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19152357
• Report Number: 2135147-2024-01783
• Device Sequence Number: 8434010
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: (01)00811806010779(17)260331(10)8979325
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 03/31/2026
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 8979325
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5MM AMPLATZER DUCT OCCLUDE
• Patient Sex: Unknown