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

Model Number	9-ITV06F180/80
Medical Device Problem Codes	Difficult to Insert (1316); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
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, an 8-6mm amplatzer duct occluder was chosen for implant using a 6f amplatzer torqvue delivery system to close a patent ductus arteriosus (pda).The pda measured 4mm at the distal pulmonary artery end with a small tail-like runoff.There was difficulty accessing the wire through the defect.A peripheral balloon was used to dilate the distal end of the pda.The device felt tight entering into the delivery system from the loader.The occluder was deployed from the delivery system, and the device prematurely detached from the cable when the aortic disc was deployed.The patient was then converted due to general anesthesia due to discomfort during procedure.A snare was placed up the arterial side, and the aortic disc was snared.A guidewire and small balloon were placed up the venous side to trap the device.The device was not able to be pulled back into the guide catheter, so another snare was placed up the venous side to snare the skirt of the device.The device was removed from the patient.After unsuccessful attempts were made to rewire the defect, the procedure was aborted due to length of procedure, a total of 2 hours 45 minutes.The patient remained hemodynamically stable throughout the procedure.The patient did not experience any clinical signs during or after this event.Outside of the patient, the device was reattached to the cable and tested outside of the patient.On all three occasions, the device felt tight exiting the loader and going into the delivery system, and approximately 2/3 of the way up the delivery system, the device became detached from the cable.Further treatment was planned for a later date.The patient status was stable.
Event or Problem Description
It was reported that on (b)(6) 2023, an 8-6mm amplatzer duct occluder was chosen for implant using a 6f amplatzer torqvue delivery system to close a patent ductus arteriosus (pda).The pda measured 4mm at the distal pulmonary artery end with a small tail-like runoff.There was difficulty accessing the wire through the defect.A peripheral balloon was used to dilate the distal end of the pda.The device felt tight entering into the delivery system from the loader.The occluder detached from the delivery cable about 2/3 of the length of the delivery system, and the physician felt the cable disconnect.Fluoroscopy showed that the device had prematurely detached from the delivery cable.The aortic disc was sitting on the aortic side of the defect.The patient was then converted to general anesthesia due to discomfort during the procedure.A snare was placed up the arterial side, and the aortic disc was snared.A guidewire and small balloon were placed up the venous side to trap the device.The device was not able to be pulled back into the guide catheter, so another snare was placed up the venous side to snare the skirt of the device.The device was subsequently removed from the patient using a transcatheter approach.Subsequently, additional attempts were made to rewire the defect, but this was not successful, and the procedure was aborted due to the length of the procedure, which was a total of 2 hours 45 minutes.The patient remained hemodynamically stable throughout the procedure.The patient did not experience any clinical signs during or after this event.Outside of the patient, the device was reattached to the cable and tested outside of the patient.On all three occasions, the device felt tight when exiting the loader and transitioning into the delivery system.Further treatment was planned for a later date.The patient status was stable.
Additional Manufacturer Narrative
Difficulty in advancing the occluder from the loader into the delivery sheath was reported.The investigation found that the loader and sheath met all dimensional specifications.The amplatzer duct occluder was loaded into the loader, advanced to the returned sheath and deployed through the sheath with ease and without detachment.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The exact cause for the detachment of the occluder from the delivery cable in this case is unknown.However, it might be possible that during the time difficulties were encountered in advancing the device from the loader into the delivery sheath additional torque may have been applied and caused the device to inadvertently unscrew from the delivery cable.The cause of the difficulty advancing the occluder into the sheath could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17336736
• Report Number: 2135147-2023-03052
• Device Sequence Number: 20736467
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 8377384
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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 DUCT OCCLUDER, 9-PDA-005, 8852648.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 95 KG