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

Model Number 9-VSD-MUSC-012

Device Problem Difficult To Position (1467)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Product investigation: the reported event of a failure to retract the amplatzer muscular vsd occluder into the 7f delivery system sheath could not be confirmed.The returned occluder met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2017, while pulling back a 7f amplatzer torqvue delivery system 45 (dtv45), the amplatzer muscular vsd occluder was in the incorrect position.The occluder failed to retract into the dtv.The dtv45 and occluder were removed from the patient and the sheath appeared damaged at the tip.On a later date, another amplatzer muscular vsd occluder was used and procedure was successfully completed.

• 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 ; 6517564470
• MDR Report Key: 7161707
• MDR Text Key: 96728086
• Report Number: 2135147-2017-00179
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 9-VSD-MUSC-012
• Device Catalogue Number: 9-VSD-MUSC-012
• Device Lot Number: 5888293
• Other Device ID Number: 00811806011820
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2017
• 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