MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-PDA-006

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the reported event of "difficulties loading the 6 mm amplatzer duct occluder into the sheath of the 6f amplatzer torqvue delivery system" was confirmed.The occluder was deformed, with the nitinol wires bunching in the diameter at the pulmonary artery.There were no dimensional or functional anomalies found with the returned delivery sheath at the time of manufacturing or upon return to abbott when tested with a test occluder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The difficulty advancing the occluder from the loader to the sheath is consistent with a deformity in the nitinol braiding.The cause of the damage to the occluder remains unknown.

Event Description

On (b)(6) 2017, there were difficulties loading the 6 mm amplatzer duct occluder into the sheath of the 6f amplatzer torqvue delivery system.Per report the user noted that the sheath appeared to be too small making it too tight to fit the device into the sheath.There was no replacement sheath in the facility and the case was abandoned.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7359008
• MDR Text Key: 103083712
• Report Number: 2135147-2018-00030
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 9-PDA-006
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 5861574
• Other Device ID Number: 00811806011134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 4 MO
• Patient Weight: 4