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

Model Number 9-ITV08F180/80

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A 12/10 mm amplatzer duct occluder (ado) was deployed and was determined to be the wrong size.The attempts to retract the ado into the 8f amplatzer torqvue 180 delivery system (dtv180) sheath were unsuccessful as the dtv180 sheath tip inverted.It was not possible to fully retract the ado.The partially retracted ado and the dtv180 sheath were both removed from the patient; however the femoral vein was damaged upon complete removal.No further intervention was required for the femoral vein.The case continued after gaining access on the opposite side and a larger 16/14 mm ado was successfully implanted using a 9f dtv180.The patient is reported to be stable.Please reference mdr-2016-08506 for the amplatzer duct occluder.

Manufacturer Narrative

(b)(4).The results of this investigation confirmed the amplatzer torqvue 180 delivery system sheath tip was inverted.A review of the device history record confirmed the delivery system met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the delivery system, and the cause for the tip inversion 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: 5546957
• MDR Text Key: 41855763
• Report Number: 2135147-2016-00042
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 9-ITV08F180/80
• Device Catalogue Number: 9-ITV08F180/80
• Device Lot Number: 4744363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention