MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZDER VSD OCCLUDER

Catalog Number TRG 9SDF-008

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Protrusion/Extrusion (2979); Positioning Problem (3009)

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

Event Date 04/07/2015

Event Type  No Answer Provided  

Event Description

Cardiologist was attempting to place a closure device to stop the blood flow through the main pulmonary artery when he encountered difficulty with getting the device to deliver properly from the lfv approach.He tried to pull the device (spectral occluder 8mm).He then had difficulty pulling the device back into the delivery system where it stuck out of the end of the system.He then had to pull the entire system sacrificing the femoral approach for this session.He accessed the rij and attempted to deliver another closure device 14mm but could not get proper placement and pulled the device out into the delivery system but it wedged in the delivery system.He was going to try a third closure device but could not get proper positioning of the delivery sheath 12mm x 10mm, but could not get proper positioning of the delivery sheath.The procedure was then aborted due to the extended lengthy of anesthesia and exhaustion of delivery options.Product info for second product used during same event.Trg 9-sdf-008 lot 1005112591 sn(b)(4) exp: 05/31/2015.

• Brand Name: AMPLATZDER VSD OCCLUDER
• Type of Device: AMPLATZDER VSD OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; plymouth MN 55442
• MDR Report Key: 4814823
• MDR Text Key: 20803116
• Report Number: MW5042880
• Device Sequence Number: 2
• Product Code: MLV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: TRG 9SDF-008
• Device Lot Number: 1005112591
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRODUCTS FOR LEFT AND RIGHT HEART CATH
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Weight: 73