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

Model Number	9-ITV06F180/80
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, a 4mm amplatzer duct occluder was selected for implant in the ductus using a 6f 180/80mm amplatzer torqvue delivery system (lot number: 6942209).While releasing the device, the site had difficulty loosening the delivery cable.The cable snapped off rather then unscrew, and part remained connected to the device.The physician elected to leave the device in place.No patient consequences were reported.
Additional Manufacturer Narrative
09/06/2019 mjr ¿ supplemental report needed to address analysis: the detached end screw of the delivery cable was confirmed.The detachment difficulty could not be investigated, as the end screw remains attached to the implanted device.The root cause of the distal end of the delivery cable detaching was traced to the laser welding process, as the exposed core wire of the returned portion of the delivery cable exhibited no evidence of weld penetration.As a result of this finding, abbott is performing further investigation.

• 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: 8791391
• Report Number: 2135147-2019-00193
• Device Sequence Number: 1845628
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 03/31/2022
• Device Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 6942209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR