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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH GUIDING INTRODUCER SWARTZ SR SERIES, SR0 8.5F; INTRODUCER, CATHETER
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ST. JUDE MEDICAL FAST-CATH GUIDING INTRODUCER SWARTZ SR SERIES, SR0 8.5F; INTRODUCER, CATHETER Back to Search Results
Model Number 406853
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/14/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The reported event of sideport tubing detachment was confirmed.The extension tubing had detached from the sideport of the hemostasis body due to an insufficient amount of solvent on the extension tubing.
 
Event or Problem Description
During the procedure, the sideport tubing had detached from the introducer.The procedure was completed with no adverse consequences to the patient.
 
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Brand Name
FAST-CATH GUIDING INTRODUCER SWARTZ SR SERIES, SR0 8.5F
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key10132651
Report Number3005334138-2020-00225
Device Sequence Number3053348
Product Code DYB
UDI-Device Identifier05414734202985
UDI-Public05414734202985
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K061015
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2022
Device Model Number406853
Device Catalogue Number406853
Device Lot Number7169043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2020
Initial Report FDA Received Date06/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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