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

Model Number	9-ITV05F180/60
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 5/4 amplatzer duct occluder i was selected for implant using 5 french delivery sheath.During the procedure, the physician could not advance the device into the hub of the sheath.After multiple attempts, a new 6 french delivery system was selected to successfully deploy the device.The physician reported a significant delay in the procedure leading to an increased amount of blood loss.The patient was reported to be stable.
Additional Manufacturer Narrative
Additional information for: g4, g7, h2, h3, h6, and h10.The advancement difficulty was confirmed upon receipt of the device.The distal tubing of the loader was also noted to be 0.005 inches under the specification tolerance, consistent with damage during use.A historical review of complaints was performed, which found the occurrence rate of this failure mode, based on reported events for advancement difficulty, is below that of the expected rate listed within the risk documentation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.This was inclusive of a go/no go gauge method for measurement of the distal end of the loader tubing.While the root cause of the advancement difficulty in this case could not be definitively determined, further investigation found that ensuring the distal luer of the loader is fully tightened over the male threads of the sheath hub mitigates difficulty advancing from the loader into the sheath.Furthermore, if the shortening of the distal end of the tubing existed during initial attempts to advance the occluder, it may have exacerbated the susceptibility to advancement difficulty due to the interaction between the loader and sheath.A historical analysis found this device family to be within its predicted occurrence rate for this failure and harm.Abbott will continue to monitor this issue.

• 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: 10277499
• Report Number: 2135147-2020-00302
• Device Sequence Number: 16702833
• Product Code: DQY
• UDI-Device Identifier: 00811806010755
• UDI-Public: 00811806010755
• Combination Product (Y/N): N
• 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): 12/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 9-ITV05F180/60
• Device Catalogue Number: 9-ITV05F180/60
• Device Lot Number: 7301596
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 5 MO
• Patient Weight: 6