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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER INTRODUCER, CATHETER

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ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER INTRODUCER, CATHETER Back to Search Results
Model Number 406103
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/12/2022
Event Type  Injury  
Event Description
During a tranacatheter aortic valve replacement (tavr) procedure, the sutures were removed and when the sheath was pulled, only the hub of the device was removed. An x-ray confirmed the sheath remained in the femoral vein. The patient was brought to interventional radiology and the sheath was removed without issue.
 
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Brand NameFAST-CATH HEMOSTASIS INTRODUCER
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
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key15200411
MDR Text Key297614095
Report Number3005334138-2022-00450
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734013772
UDI-Public05414734013772
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K914090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number406103
Device Catalogue Number406103
Device Lot Number8493480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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