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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F INTRODUCER, CATHETER

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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F INTRODUCER, CATHETER Back to Search Results
Model Number 407439
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2022
Event Type  malfunction  
Event Description
During the left atrioventricular reentrant tachycardia procedure, the needle with stylet punctured the sheath. The sheath was exchanged and the procedure was completed with no adverse patient health consequences.
 
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Brand NameSWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 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 Key15265101
MDR Text Key299405515
Report Number3005334138-2022-00481
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeBR
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 08/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number407439
Device Catalogue Number407439
Device Lot Number8334316
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
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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