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

Model Number 9-VSD-MUSC-014

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 04/07/2015

Event Type  Injury  

Event Description

An attempt to place an 8 mm septal occluder was undertaken to stop the blood flow through the main pulmonary artery.Difficulty was encountered with getting the device to deploy properly from the left femoral vein approach.An attempt was made to retract the device, but difficulty was encountered while pulling the device back into the delivery system and the femoral approach was abandoned.The access was converted to the right internal jugular vein for the attempted delivery of a 14 mm amplatzer muscular vsd occluder (muscvsd).Proper placement could not be achieved and upon pulling the device into the delivery system, the device wedged and was unable to be used.A third attempt with a closure device was abandoned as proper positioning could not be achieved of the delivery sheath (12 mm x 10 mm).Due to the extended length of anesthesia and exhaustion of delivery options no further attempts were undertaken.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER MUSCULAR VSD 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 ; 6517565400
• MDR Report Key: 4884516
• MDR Text Key: 6260873
• Report Number: 2135147-2015-00067
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 9-VSD-MUSC-014
• Device Catalogue Number: 9-VSD-MUSC-014
• Device Lot Number: 4951014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 74