MAUDE Adverse Event Report: AGA MEDICAL CORP AMPLATZER SEPTAL OCCLUDER

Catalog Number REF 9-ASD-019

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

Pt with asd in cath lab for asd device closure.When attempted to place an amplatzer septal occluder, but by using tee guidance we were able to see a moving protrusion from the device.The device was removed from the delivery system and examined closely.A thread of the dacron material of the device was hanging out.A new device was taken and used for a successful closure of the asd.Defective device to risk management.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: AMPLATZER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORP; plymouth MN 55442
• MDR Report Key: 4664962
• MDR Text Key: 5730428
• Report Number: MW5041903
• Device Sequence Number: 1
• Product Code: MLV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: REF 9-ASD-019
• Device Lot Number: 3943923
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASD CLOSURE
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 19