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

Model Number	9-ITV07F180/80
Medical Device Problem Codes	Material Invagination (1336); Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 2135147-2019-00145.On (b)(6) 2019, a 10/8mm amplatzer duct occluder (ado) was selected for implant using a 7f amplatzer torqvue delivery system.The device was attempted to be positioned twice, but the device embolized into the pulmonary artery while attached to the delivery cable.The device was attempted to be re-sheathed, but the tip of the delivery system was invaginated preventing a successful recapture.The device was surgically removed and the patent ductus arteriosus was ligated.The patient was recovery and scheduled to be discharged.
Additional Manufacturer Narrative
The reported event of a inverted sheath tip was confirmed.Gross morphological examination revealed the soft tip was inverted, and no other damage was found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.
Event or Problem Description
On (b)(6) 2019, a 10/8mm amplatzer duct occluder (ado) was selected for implant using a 7f amplatzer torqvue delivery system.The device embolized into the pulmonary artery twice while attached to the delivery cable.The tip of the delivery sheath was observed to be invaginated and the physician was unable to re-sheath the device.The patient was referred to surgery and the ado was removed from the patient.On (b)(6) 2019, the patient was reported to be discharged.

• 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: 8669059
• Report Number: 2135147-2019-00144
• Device Sequence Number: 11304928
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: 00811806010793
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 07/23/2019

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: 04/30/2020
• Device Model Number: 9-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 5984551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: Required Intervention
• Patient Age: 7 MO