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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER INTRODUCER, CATHETER

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ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER INTRODUCER, CATHETER Back to Search Results
Model Number C407698
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895)
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative
Product evaluation: an event of hemorrhaging and cardiac arrest 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. Based on the information received, the cause of the reported incident could not be conclusively determined. The ultimum hemostasis introducer sheath instructions for use (ifu) instructs the user to insert the dilator into hemostasis valve and then follow normal accepted practice for vessel puncture, guidewire insertion, vessel dilator and hemostasis introducer use. The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations. The ultimum hemostasis introducer sheath instructions for use (ifu) states that prior to proceeding, verify the hemostasis introducer is of proper size to allow passage of desired catheter or other medical device.
 
Event Description
Patient lost blood pressure and had cardiac arrest after a tavi procedure with portico. The valve was successfully implanted and physicians were closing the access site in the femoral arteries when it became clear the patient had a large bleed by the femoral access point by unknown cause. It could be caused by removal of the ultimum ev hemostasis introducer, introducing of the closure device (manta) or the wire itself. They managed to stop the bleed by covered stents and the patient recovered well. Evaluation of the portico after resuscitation and patient recovery was working perfectly and the patient was hemodynamic stable.
 
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Brand NameULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6981470
MDR Text Key90384982
Report Number3005334138-2017-00183
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K092575
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Model NumberC407698
Device Catalogue NumberC407698
Device Lot Number5951579
Other Device ID Number05415067009692
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 Received10/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2017
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: 10/26/2017 Patient Sequence Number: 1
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