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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE INTRODUCER, CATHETER

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ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE INTRODUCER, CATHETER Back to Search Results
Model Number 406948
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2022
Event Type  malfunction  
Event Description
During a transseptal approach, the needle punctured the introducer. The introducer was replaced to complete the procedure with no consequences to the patient.
 
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Brand NameFAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE
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 Key15319396
MDR Text Key299405814
Report Number3005334138-2022-00492
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734203531
UDI-Public05414734203531
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 08/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406948
Device Catalogue Number406948
Device Lot Number8352576
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2022
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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