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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 406840
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2022
Event Type  malfunction  
Event Description
Related manufacturing ref: 3005334138-2022-00483. During the atrial fibrillation procedure, air was introduced into the right side of the heart after a brockenbrough when the catheter was removed and the sheath was being replaced after the guidewire was inserted into the introducer. There were no adverse patient consequences.
 
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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 Key15278344
MDR Text Key299405796
Report Number3005334138-2022-00484
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734203340
UDI-Public05414734203340
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 09/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406840
Device Catalogue Number406840
Device Lot Number8383076
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2022
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: 08/23/2022 Patient Sequence Number: 1
Treatment
FAST-CATH TRANSSEPTAL GUIDING INTRODUCER
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