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

Model Number	9-ITV07F180/80
Medical Device Problem Codes	Retraction Problem (1536); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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 on (b)(6) 2025 a 12-10mm amplatzer duct occluder was selected for a procedure using a 7f amplatzer torqvue delivery system to treat a patent ductus arteriosus.During deployment the occluder moved to the pulmonary side.An attempt was made to partially re-capture the occluder and re-deploy, however the occluder could not be partially re-captured to the delivery system.Upon the third attempt to re-capture the occluder, the occluder prematurely detached from the delivery cable and embolized to the right pulmonary branch.The patient remained hemodynamically stable throughout the procedure but was noted to have lost a small amount of blood.The patient was transferred to surgery to remove the occluder.The patient status was stable.
Event or Problem Description
It was reported on (b)(6) 2025 a 12-10mm amplatzer duct occluder was selected for a procedure using a 7f amplatzer torqvue delivery system to treat a patent ductus arteriosus (pda).The pda was measured at 21.6mm.The sizing of the device was determined with intracardiac echocardiography (ice).Fluoroscopy and ice were used during the procedure.During deployment the occluder moved to the pulmonary side.An attempt was made to partially re-capture the occluder and re-deploy, however the occluder could not be partially re-captured to the delivery system.Upon the third attempt to re-capture the occluder, the occluder prematurely detached from the delivery cable and embolized to the right pulmonary branch.The patient remained hemodynamically stable throughout the procedure but was noted to have lost a small amount of blood.The patient was transferred to surgery to remove the occluder.The patient status was stable.
Additional Manufacturer Narrative
An event premature separation of device and an event of retraction problem during the procedure were reported.Information from the field indicated that the device was sized using intracardiac echocardiography (ice), and the device were prepared per ifu.The field also indicated that the patient does not have tortuous anatomy, and no resistance advancing the delivery system through the patient anatomy.Information from the field indicated that attempts made to partially re-capture and during the 3rd attempt of recapture, the occluder prematurely detached from the delivery cable.A returned device assessment could not be performed since the device remains implanted and 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 premature separation of device could not be conclusively determined.The reported retraction problem could be due to multiple times of re-capturing the device.However, this cannot 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: 21977856
• Report Number: 2135147-2025-02403
• Device Sequence Number: 13058472
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: (01)00811806010793(17)270228(10)10274756
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/23/2025

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 Model Number: 9-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 10274756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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: 12-10MM AMPLATZER DUCT [9-PDA-007 LOT: 10400068]
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 22 KG