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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 Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
One 8. 5f swartz braided introducer sheath and dilator were received for evaluation. The dilator was perforated at 1. 49¿ and 1. 58¿ proximal to the distal tip. The sheath was also perforated at 0. 21¿ and 0. 31¿ proximal to the distal tip. A needle/stylet assembly from current inventory was inserted and advanced through the dilator; however, the needle could not advance past the location of the dilator perforations. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the sheath and dilator perforation remain unknown.
 
Event Description
This report is to advise of a perforation on the introducer and dilator found during analysis. During the procedure, the physician was unable to put the needle inside the sheath. The sheath was replaced and the procedure was completed with no adverse consequences to the patient. A stylet was used and the needle was not reshaped.
 
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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 Key15258451
MDR Text Key299405550
Report Number3005334138-2022-00479
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734205771
UDI-Public05414734205771
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 08/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number407453
Device Catalogue Number407453
Device Lot Number8311954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2022
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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