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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F INTRODUCER, CATHETER

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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F INTRODUCER, CATHETER Back to Search Results
Model Number 407451
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pseudoaneurysm (2605)
Event Date 09/24/2021
Event Type  Injury  
Event Description
During the procedure, a right sided pseudoaneurysm occurred which was treated with a thrombin injection.
 
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Brand NameSWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F
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
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key13829063
MDR Text Key287533954
Report Number3005334138-2022-00251
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeNL
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 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number407451
Device Catalogue Number407451
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2022 Patient Sequence Number: 1
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