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

Catalog Number	9-ITV08F180/80
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
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 a 14-12mm amplatzer duct occluder was selected for implant on (b)(6) 2024, using an 8f amplatzer torqvue delivery system.The defect was measured as 7mm in diameter and 9mm in length via transesophageal echocardiography (tee).The devices were prepared per ifu.Echocardiogram and fluoroscopy were used during the procedure.During implant, the cable connection was checked prior to deployment.While deploying the device, it was observed through fluoroscopy that the device prematurely detached from the delivery cable.The device embolized into the descending aorta.The device was snared via transcatheter snare and removed from the patient.A new 16-14mm amplatzer duct occluder and 8f amplatzer torqvue delivery system were used to complete the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
An event of premature separation was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported incident could not be conclusively determined.It is possible rotation of the delivery cable during advancement led to the device disengaging; however, this could not be confirmed.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: 19924501
• Report Number: 2135147-2024-03831
• Device Sequence Number: 14164760
• Product Code: DQY
• UDI-Device Identifier: 00811806010823
• UDI-Public: (01)00811806010823(17)261231(10)10159647
• 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): 09/25/2024

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 Catalogue Number: 9-ITV08F180/80
• Device Lot Number: 10159647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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 DUCT OCCLUDER, 9-PDA-008, LOT 7357998
• Patient Sex: Male