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

Model Number	9-ITV07F45/60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that on (b)(6) 2021, a 7f amplatzer torqvue delivery system was chosen for procedure in a ventricular septal defect (vsd) closure case.While doing a retrograde arteriovenous (av) loop, after advancing the torqvue sheath through the right ventricle, the patient went into asystole and it was noticed that the patient's right ventricular (rv) permanent pacing lead had become dislodged.The patient required emergent percutaneous pacing and cpr, and the patient was in asystole for a total of less than 60 seconds.The procedure had to be aborted without successful closure of the vsd.The patient received the new rv lead 30 minutes after the vsd closure procedure was aborted.The physician noted that the trajectory of delivering the system through the vsd was challenging.Due to the difficult angle, the delivery system may have dislodged the lead, but this was unable to confirmed.There was no visualization of the lead being dislodged, and it was only noticed after the patient was in asystole.No additional information was provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that on (b)(6) 2021, a 7f amplatzer torqvue delivery system was chosen for procedure in a ventricular septal defect (vsd) closure case.While doing a retrograde arteriovenous (av) loop, after advancing the torqvue sheath through the right ventricle, the patient went into asystole and it was noticed that the patient's right ventricular (rv) permanent pacing lead had become dislodged.The patient required emergent percutaneous pacing and cpr, and the patient was in asystole for a total of less than 60 seconds.The procedure had to be aborted without successful closure of the vsd.The patient received the new rv lead 30 minutes after the vsd closure procedure was aborted.The physician noted that the trajectory of delivering the system through the vsd was challenging.Due to the difficult angle, the delivery system may have dislodged the lead, but this was unable to confirmed.There was no visualization of the lead being dislodged, and it was only noticed after the patient was in asystole.No additional information was provided.
Additional Manufacturer Narrative
An event of the patient going into asystole after the patient's right ventricular permeant pacing lead was dislodged while doing a arteriovenous loop after advancing the torqvue sheath through the right ventricle was reported.A more comprehensive 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 information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13226601
• Report Number: 2135147-2022-00014
• Device Sequence Number: 19858711
• Product Code: DQY
• UDI-Device Identifier: 00811806010809
• UDI-Public: 00811806010809
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 08/31/2023
• Device Model Number: 9-ITV07F45/60
• Device Catalogue Number: 9-ITV07F45/60
• Device Lot Number: 7669599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male