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

Catalog Number	9-ITV07F180/80
Medical Device Problem Codes	Retraction Problem (1536); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 8-6mm amplatzer duct occluder was selected for implant on (b)(6) 2024.During the procedure the device was inserted into the patient and attempted to be deployed.It was noted that the position of the device was not correct when attempting to close the device.The device was observed to have slipped from the aorta to the main pulmonary artery.There was difficulty re-capturing the device.Multiple attempts were made to re-capture the device but were unsuccessful.The delivery system was removed and replaced with a new 7f amplatzer torqvue delivery system.The device was still unable to be implanted.The occluder and delivery system were both removed from the patient.The patient was referred to surgical treatment.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional 9-pda-005 device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that a 8-6mm amplatzer duct occluder was selected for implant on (b)(6) 2024 using a 6f amplatzer torqvue delivery system.During the procedure the device was inserted into the patient and attempted to be deployed.It was noted that the position of the device was not correct when attempting to close the device.The device slipped from the aorta to the main pulmonary artery (mpa).There was difficulty re-capturing the device.Multiple attempts were made to re-capture the device.The device could not be re-captured back to the delivery system.A second 7f amplatzer torqvue delivery system was opened to attempt to retrieve the occluder.However, the second delivery system could not be used due to the wire attached to the occluder from the first delivery system in the mpa was too short for a wire exchange.More attempts were made to re-capture the occluder.After 20 minutes the occluder was successfully re-captured and removed from the patient.The patient was referred to surgical treatment.Surgical ligation was performed via lateral thoracotomy.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
An event of mal-positioning and difficulty in recapturing the 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 delivery system was opened to attempt to retrieve the occluder.However, the second delivery system could not be used due to the wire attached to the occluder from the first delivery system in the mpa was too short for a wire exchange.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 medical device problem code: code 3009 removed.

• 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: 19455464
• Report Number: 2135147-2024-02586
• Device Sequence Number: 6652394
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: (01)00811806010793(17)231130(10)7777860
• Combination Product (Y/N): N
• 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): 07/23/2024

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: 11/30/2023
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 7777860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2020
• 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
• Patient Age: 7 MO
• Patient Sex: Unknown
• Patient Weight: 8 KG