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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER
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AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Model Number 9-ASD-MF-035
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
The reported event of a round, bulbous deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.
 
Event Description
On (b)(6) 2020, during pfo procedure, the occluder closure system did not allow a proper deployment of the prothesis.The device was in contact with the patient and the deformation was noticed during the deployment of the left and right discs before the device was released.The left disc appeared swollen and the hub twisted.The device was exchanged with a new amplatzer occluder device, 9-asd-mf-035.No clinical consequences were observed.
 
Manufacturer Narrative
The reported event of a round, bulbous deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.
 
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Brand Name
AMPLATZER CRIBRIFORM OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
MDR Report Key11057763
MDR Text Key223451336
Report Number2135147-2020-00552
Device Sequence Number1
Product Code MLV
UDI-Device Identifier00811806010311
UDI-Public00811806010311
Combination Product (y/n)N
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9-ASD-MF-035
Device Catalogue Number9-ASD-MF-035
Device Lot Number7347026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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