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

Catalog Number	9-ITV06F180/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 6-4mm amplatzer duct occluder was selected for implant on (b)(6) 2023 using a 6f amplatzer torqvue delivery system to close a type a patent ductus arteriosus.During implant, the patient's blood pressure dropped to 50mmhg in a transient manner when the delivery system crossed the tricuspid valve.The occluder and delivery system were removed and replaced with a new 5-4mm amplatzer duct occluder and 5f amplatzer torqvue delivery system.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of hypotension was reported.A returned device assessment 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.Based on the received information the cause of the reported event could not be conclusively determined.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: 18517653
• Report Number: 2135147-2024-00246
• Device Sequence Number: 6751302
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 9071784
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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: 6-4MM AMPLATZER DUCT OCCLUDER [9-PDA-004].
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 MO
• Patient Sex: Female