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

Model Number	9-ITV06F180/80
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 10mm by 8mm amplatzer duct occluder was selected for implantation using a 6f amplatzer torqvue delivery system.During the procedure, during deployment, it was decided that the device was too large for patient anatomy.When it was attempted to removed the device from patient anatomy, it was found that the device would not retract back into the delivery system.The delivery system was then carefully retracted from patient anatomy with the device sticking out of the end.The device was replaced with an 8mm by 6mm amplatzer duct occluder using a new 6f amplatzer torqvue delivery system with the same lot number.There were no reported patient consequences.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 10mm by 8mm amplatzer duct occluder was selected for implantation using a 6f amplatzer torqvue delivery system.During the procedure, during deployment, it was decided that the device was too large for patient anatomy.When it was attempted to removed the device from patient anatomy, it was found that the device would not retract back into the delivery system.The delivery system was then carefully retracted from patient anatomy with the device sticking out of the end.The device was replaced with an 8mm by 6mm amplatzer duct occluder using a new 6f amplatzer torqvue delivery system with the same lot number.There were no reported patient consequences.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of difficulty retrieving the amplatzer duct occluder back into the delivery sheath could not be confirmed.The delivery sheath was found to be damaged when examined upon return to abbott.The sheath was grossly examined, and the tip was noted to be deformed when analyzed at abbott under non-physiological conditions.The device met dimensional and functional testing despite the damage noted to the sheath.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 reported incident could not be conclusively determined.No other complaints were reported on this 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: 16846978
• Report Number: 2135147-2023-01890
• Device Sequence Number: 7548031
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 06/05/2023

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 Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 8616654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE DS, 9-ITV06F180/80, 8616654
• Patient Sex: Unknown