MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM

Model Number 9-ITV10F45/80

Device Problem Air Leak (1008)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 12/06/2013

Event Type  Injury  

Event Description

A 10f amplatzer torqvue 45 delivery system (dtv45) was used to implant a 26mm amplatzer septal occluder (aso).As the dilator was removed and as the physician was about to attach the loader to the sheath, the patient took a deep breath.The ekg revealed the patient's heart rate exhibited st elevations and third-degree heart block which the physician suspected was due to air withdrawn into the left atrium and right coronary artery so a temporary pacemaker was implanted.When the patient's normal rhythm was restored and the aso was implanted, the temporary pacemaker was removed.No adverse patient effects were reported and the 26mm aso remains implanted.

Manufacturer Narrative

The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation are inconclusive because the product was not returned for analysis; however, review of the device history record confirmed the product met manufacturing requirements prior to shipment.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 3547816
• MDR Text Key: 3981745
• Report Number: 2135147-2013-00134
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/11/2015
• Device Model Number: 9-ITV10F45/80
• Device Lot Number: 1212273776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR