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

Model Number 9-ITV05F180/60

Device Problem Difficult to Insert (1316)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event 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.

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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10277499
• MDR Text Key: 198921064
• Report Number: 2135147-2020-00302
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00811806010755
• UDI-Public: 00811806010755
• Combination Product (y/n): N
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 5 MO
• Patient Weight: 6