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

Catalog 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	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.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 an 5-4mm amplatzer duct occluder was selected for implant on (b)(6) 2024 using a 6f amplatzer torqvue delivery system.During the procedure it was noted that the device was unable to be retracted into the delivery system for a recapture.The device was removed from the patient and the delivery system was replaced with a new 6f amplatzer torqvue delivery system.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
An event of difficulty in recapturing the amulet occluder was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that no anatomical interference or angulation, or a kink in the delivery system was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that an 5-4mm amplatzer duct occluder was selected for implant on (b)(6) 2024 using a 6f amplatzer torqvue delivery system.During the procedure it was noted that the device was unable to be retracted into the delivery system for a recapture.The device was removed from the patient and the delivery system was replaced with a new 6f amplatzer torqvue delivery system.The device was implanted.The patient did not present with any clinical signs or symptoms.The patient status was stable.

• 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: 18992551
• Report Number: 2135147-2024-01372
• Device Sequence Number: 3051244
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: (01)00811806010779(17)260228(10)8961288
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 02/28/2026
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 8961288
• 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: 03/03/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2023
• 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: 5-4MM AMPL DUCT OCCL [9-PDA-003 LOT: 8517893].
• Patient Sex: Unknown