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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM INTRODUCER INTRODUCER, CATHETER

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ST. JUDE MEDICAL ULTIMUM INTRODUCER INTRODUCER, CATHETER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Aneurysm (1708); Hemostasis (1895)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
Updated information revealed that the manufacturing site listed in this report is incorrect. The correct manufacturing site is st. Jude medical (b)(4).
 
Event Description
According to an article ¿percutaneous carotid artery access in infants < 3 months of age," catheterization and cardiovascular interventions 87:757-761 (2016), a (b)(6) infant with pulmonary atresia intact ventricular septum underwent ductal stenting on day of life 6. A 4fr. Ultimum sheath was inserted into the carotid arteriotomy. Heparin 70 ¿ 100 u/kg was given to maintain activated clotting time of >200 seconds. A vascular ultrasound performed 12 hours post procedure showed a fistula involving the right carotid artery to internal jugular vein. Heparin was discontinued, aspirin initiated, and manual compression was applied, but was unsuccessful. The patient underwent surgery where no fistula was found but a pseudoaneurysm was identified and repaired. Doi: 10. 1002/ccd. 26310.
 
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Brand NameULTIMUM INTRODUCER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442 2126
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442 2126
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key7266244
MDR Text Key107903031
Report Number2182269-2018-00021
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/13/2018 Patient Sequence Number: 1
Treatment
HEPARIN (70-100 U/KG)
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