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

Model Number	9-ITV06F180/80
Medical Device Problem Codes	Retraction Problem (1536); Device Damaged by Another Device (2915); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 6-4mm amplatzer patent ductus arteriosus (pda) occluder was selected for implant using a 6f amplatzer torqvue delivery system.During device preparation the occluder was rotated counter-clockwise 1/8 of one turn to facilitate device release upon deployment, as per the instructions for use.It was noted during procedure that the occluder was unable to be detached from the delivery cable, even after multiple attempts.The physician did check the cable connection and the delivery cable was not at an extreme angle in relation to the disc.The decision was made to recapture and remove the 6-4mm amplatzer (pda) occluder.It's noted after recapture and removal of occluder, that the 6f amplatzer torqvue delivery system had slight warping/damage.The decision was made to replace the 6-4mm amplatzer (pda) occluder with another one of the same size and 6f amplatzer torqvue delivery system to complete the procedure.There were no adverse patient consequences reported.The patient was stable at the time of report.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that 6-4mm amplatzer patent ductus arteriosus (pda) occluder recaptured 2-3 times during procedure.It's also noted that the occluder was difficult to pull back/retract into the 6f amplatzer torqvue delivery system and resulted in damage to the delivery system.The cause for retraction difficulty is unknown.
Additional Manufacturer Narrative
An event of retraction problem, separation failure and invaginated catheter tip was reported.The device was returned to abbott for investigation.The returned device was able to be attached and detached from the returned delivery cable without difficulties meeting requirements.It was indicated that during implantation occluder was recaptured 2-3 times.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.However, the damage found was consistent with usage of the device.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 north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21461855
• Report Number: 2135147-2025-00948
• Device Sequence Number: 7913685
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: (01)00811806010779(17)270331(10)10305633
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/03/2025

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 Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 10305633
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 03/22/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: AMPLATZER (PDA) OCCLUDER, 9-PDA-004 (LOT: 10098784; AMPLATZER (PDA) OCCLUDER, 9-PDA-004 (LOT: 10098784
• Patient Sex: Unknown