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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 406183
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2022
Event Type  malfunction  
Event Description
During the atrial fibrillation procedure, air was aspirated when the sheath was inserted into the patient and air was removed. The introducer was replaced and the procedure was completed with no adverse patient consequences.
 
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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 Key15210625
MDR Text Key299405654
Report Number3005334138-2022-00470
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734014458
UDI-Public05414734014458
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K914090
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 08/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406183
Device Catalogue Number406183
Device Lot Number8294377
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 Manufactured01/14/2022
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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