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

Model Number	9-ITV06F180/80
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 6mm amplatzer duct occluder was selected for implant in an infant with a 6fr amplatzer torqvue delivery system.During device preparation, there was no issue loading the device.During placement, the user was unable to re-sheath the device as the occluder was caught on the sheath.Due to the failure to re-capture the device, the patient was sent for surgical removal of the device where the sheath was exchanged for a cook sheath and the device was pulled to the ivc and retrieved through the cook sheath.The case was aborted without closure of the defect.The delivery sheath was inspected and observed to be invaginated at the terminal end.
Additional Manufacturer Narrative
An event of an inability to retract the occluder into the delivery sheath was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
An event of failure retracting the device into the sheath was reported.The tip invagination was confirmed.The sheath tubing was also found to be wavy.Gross morphological examination revealed the sheath tip was inverted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the inability to retract the occluder remains unknown.The inverted sheath tip and sheath tubing damage was consistent with a forceful attempt to re-sheath the occluder.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7901930
• Report Number: 2135147-2018-00159
• Device Sequence Number: 1433709
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2019

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: 12/31/2020
• Device Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 6301838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 01/04/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/13/2018; 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 1 YR
• Patient Weight: 10