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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8F INTRODUCER, CATHETER

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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8F INTRODUCER, CATHETER Back to Search Results
Model Number 407360
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2022
Event Type  malfunction  
Event Description
During the procedure, a perforation in the sheath was noted during removal from the patient at the femoral site. Blockage of the needle at the level of the iliac vein was noted resulting in a need to replace the sheath. There were no adverse patient consequences.
 
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Brand NameSWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8F
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 Key15282305
MDR Text Key299405667
Report Number3005334138-2022-00482
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734205559
UDI-Public05414734205559
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K052644
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 10/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number407360
Device Catalogue Number407360
Device Lot Number8531710
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 Received10/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2022
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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