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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQUE 180 7 FR. DELIVERY SYSTEM

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AGA MEDICAL CORPORATION AMPLATZER TORQUE 180 7 FR. DELIVERY SYSTEM Back to Search Results
Lot Number 4314493
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Injury (2348)
Event Date 06/23/2015
Event Type  Injury  
Event Description

Pt experienced embolization of pda device 24 hours post implant requiring repeat catheterization for retrieval. Pt experienced hemodynamically significant bleeding in retroperitoneal space which ultimately required surgical evacuation. Pt found to have a laceration of the iliac artery related to arterial sheath for device retrieval. Pt ultimately developed left foot ischemia requiring amputation secondary to vascular injury.

 
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Brand NameAMPLATZER TORQUE 180
Type of Device7 FR. DELIVERY SYSTEM
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
MDR Report Key4935931
MDR Text Key6432657
Report NumberMW5044647
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2016
Device LOT Number4314493
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/17/2015 Patient Sequence Number: 1
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