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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR
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ST. JUDE MEDICAL ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problems Syncope (1610); Death (1802); Hematoma (1884); Heart Failure (2206)
Event Date 02/11/2016
Event Type  Death  
Event Description
My son underwent a cardiac catheterization on (b)(6) 2016, at (b)(6) hospital in (b)(6).The physician who performed the procedure, dr.(b)(6), stated in his notes, "we actually perked the artery quite high up in the groin - iliac above the inguinal ligament.The vessel was not very large.We were well above the bifurcation of the common femoral artery, and i then elected to put an angio-seal closure device in the artery access, which was tolerated pretty well." my son was released from the hospital the same day.Upon arrival at home he passed out.Paramedics took him to the hospital.It was determined that he had retroperitoneal hematoma from the failed vascular closure device.His heart stopped several times.Surgery was performed.My son's brain activity stopped on (b)(6) 2016.He was pronounced dead on (b)(6) 2016.The instructions for use of the angio-seal device states, "do not use the angio-seal device if the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma.".
 
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Brand Name
ANGIO-SEAL
Type of Device
DEVICE, HEMOSTASIS, VASCULAR
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key6773107
MDR Text Key82143015
Report NumberMW5071408
Device Sequence Number1
Product Code MGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening;
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