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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8. INTRODUCER, CATHETER

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ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8. INTRODUCER, CATHETER Back to Search Results
Model Number 406849
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
This report is to advise of an event observed during analysis confirming a fluid leak from the introducer.
 
Manufacturer Narrative
One 8. 5f fast-cath introducer sheath was received for evaluation. The dilator was also received. A leak was noted in the hemostasis valve. The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected. Tearing, resulting in a hole, was noted in the side wall of the seal. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the torn seal and subsequent leak remains unknown. The ifu states: do not remove dilator or catheter rapidly. Damage to the valve may occur, potentially compromising hemostasis.
 
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Brand NameFAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.
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 Key13661005
MDR Text Key286650633
Report Number3005334138-2022-00201
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734203388
UDI-Public05414734203388
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K061015
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 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406849
Device Catalogue Number406849
Device Lot Number7802078
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2021
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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