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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION DELIVERY SYSTEM ITV 7F 180/80 US

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AGA MEDICAL CORPORATION DELIVERY SYSTEM ITV 7F 180/80 US Back to Search Results
Model Number 9-ITV07F180/80
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888); Ischemia (1942); Laceration(s) (1946); Patient Problem/Medical Problem (2688)
Event Date 06/23/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The patient experienced an embolization of an amplatzer duct occluder (ado) 24 hours post implant which required a repeat catheterization for retrieval. The patient experienced hemodynamically significant bleeding in the retroperitoneal space which required surgical evacuation. The patient was found to have a laceration of the iliac artery related to the 7f amplatzer torqvue 180 delivery system (dtv180) that was used for the ado retrieval. The patient developed left foot ischemia which required amputation secondary to the vascular injury. Please reference mdr# 2135147-2015-00137 for the ado.

 
Manufacturer Narrative

(b)(4). The results of the investigation are inconclusive since the device was not returned for analysis. Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures. Based on the information received, the cause of the reported incident could not be conclusively determined.

 
Event Description

The patient experienced an embolization of a 5/4 mm amplatzer duct occluder (ado) 24 hours post implant which required a repeat catheterization for retrieval. The patient experienced hemodynamically significant bleeding in the retroperitoneal space which required surgical evacuation. The patient was found to have a laceration of the iliac artery related to the 7f amplater torqvue 180 delivery system (dtv180) that was used for the ado retrieval. The patient developed left foot ischemia which required amputation secondary to the vascular injury.

 
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Brand NameDELIVERY SYSTEM ITV 7F 180/80 US
Type of DeviceDELIVERY SYSTEM
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 Key5219964
MDR Text Key31000856
Report Number2135147-2015-00136
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 10/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2016
Device MODEL Number9-ITV07F180/80
Device Catalogue Number9-ITV07F180/80
Device LOT Number4314493
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/12/2015 Patient Sequence Number: 1
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