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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 406543
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/10/2022
Event Type  Injury  
Event Description
During the supraventricular arrhythmia procedure, the introducer broke and a portion remained in the femoral access site. The detached portion was removed with a clamp via x-ray with no consequences to the patient.
 
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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 Key15243166
MDR Text Key298077207
Report Number3005334138-2022-00478
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734216913
UDI-Public05414734216913
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K061015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number406543
Device Catalogue Number406543
Device Lot Number7887374
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2021
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: 08/17/2022 Patient Sequence Number: 1
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