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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F TRANSSEPTAL CATHETER INTRODUCER Back to Search Results
Model Number G407376
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
Event Type  Injury  
Event Description
During the atrial fibrillation procedure, a second puncture site was needed because when the introducer was inserted into the patient, the initial puncture site was stiff possibly due to scar tissue from previous procedures. As a result, the introducer became kinked. The introducer was replaced and the procedure was completed with no adverse consequences to the patient. The hospital discarded the reported introducer.
 
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Brand NameSWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F
Type of DeviceTRANSSEPTAL CATHETER INTRODUCER
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 Key15108388
MDR Text Key296652055
Report Number3005334138-2022-00439
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
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 08/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG407376
Device Lot Number8454555
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2022
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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