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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 Problems Flaked (1246); Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2022
Event Type  malfunction  
Event Description
During atrial fibrillation procedure, skiving was noted. After making the transseptal procedure with the sheath and the brk needle, resistance was encountered and when the needle was removed pieces of scraped substance of the dilator with the brk needle exited from the tip of the dilator. The sheath set was replaced and the procedure was completed with no adverse consequences to the patient.
 
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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
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key14946907
MDR Text Key299370691
Report Number3005334138-2022-00377
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 07/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number407451
Device Catalogue Number407451
Device Lot Number8318572
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2022
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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