AMPLATZER TORQVUE DELIVERY SYSTEM 9-ITV08F45/80

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for AMPLATZER TORQVUE DELIVERY SYSTEM 9-ITV08F45/80 manufactured by Aga Medical Corporation.

Event Text Entries

[186212173] An event premature release while attempting to reposition the occluder was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications. Based on the information received, the cause of the reported incident could not be conclusively determined.?
Patient Sequence No: 1, Text Type: N, H10


[186212274] Reference manufacturing report number: 2135147-2020-00139. On (b)(6) 2020, a 16-14 amplatzer duct occluder was selected for implant for a sinus valsalva aneurysm with an 8f/45 torqvue delivery system. After deploying the device and prior to release, the physician was not satisfied with the positioning of the device. The physician attempted to retract the device, but it prematurely released from the delivery system and embolized to the pulmonary artery. A 10f/45 torqvue delivery system was used to retrieve the device without success. The patient was stable when referred to surgery to retrieve the device and close the defect. There were no patient consequences. No additional information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2135147-2020-00140
MDR Report Key9900948
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-05
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-08-22
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAMELA YIP
Manufacturer Street5050 NATHAN LANE N
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1AGA MEDICAL CORPORATION
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Generic NameCATHETER, PERCUTANEOUS
Product CodeDQY
Date Received2020-03-30
Model Number9-ITV08F45/80
Catalog Number9-ITV08F45/80
Lot Number7146845
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAGA MEDICAL CORPORATION
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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