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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F INTRODUCER, CATHETER

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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F INTRODUCER, CATHETER Back to Search Results
Model Number 407453
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2022
Event Type  malfunction  
Event Description
During a transcatheter aortic valve implantation (tavi) procedure, air was aspirated into the syringe that connects to the extension port of the sheath. Several aspirations were attempted, however, air remained. The sheath set was replaced and the procedure was completed with no adverse consequences to the patient. No additional femoral vein puncture was required for replacing the sheath.
 
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Brand NameSWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F
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 Key15301198
MDR Text Key299683312
Report Number3005334138-2022-00488
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734205771
UDI-Public05414734205771
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 09/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number407453
Device Catalogue Number407453
Device Lot Number7515262
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2020
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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