• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL ULTIMUM HEMOSTASIS TRANSRADIAL KIT INTRODUCER, CATHETER Back to Search Results
Model Number C407595
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Vascular Dissection (3160)
Event Date 12/22/2020
Event Type  Injury  
Manufacturer Narrative
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 dissection could not be conclusively determined.
 
Event Description
At the end of the interventional cerebral aneurysm embolization procedure, the guidewire was pushed out to pull out the vascular sheath and during the process, the guidewire punctured a blood vessel. Blood extravasation and subcutaneous congestion were noted. Compression and a vascular suture device were used to stabilize the patient. The guidewire was noted to be too hard.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTIMUM HEMOSTASIS TRANSRADIAL KIT
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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key11169502
MDR Text Key226776170
Report Number3005334138-2020-00655
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734025690
UDI-Public05414734025690
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K031137
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 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberC407595
Device Catalogue NumberC407595
Device Lot Number7581918
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2020
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: 01/14/2021 Patient Sequence Number: 1
-
-