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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿; INTRODUCER, CATHETER
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ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿; INTRODUCER, CATHETER Back to Search Results
Model Number 406844
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/27/2018
Type of Reportable Event Malfunction
Event or Problem Description
During the procedure, the fast-cath introducer had blood leak from the valve.Another introducer was used to complete the procedure with no adverse consequences to the patient.
 
Additional Manufacturer Narrative
One fast-cath introducer was returned.The reported leak could not be confirmed.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.
 
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Brand Name
FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key8269384
Report Number3005334138-2019-00014
Device Sequence Number16693976
Product Code DYB
UDI-Device Identifier05414734202930
UDI-Public05414734202930
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K061015
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/21/2019
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 Date04/30/2021
Device Model Number406844
Device Catalogue Number406844
Device Lot Number6478955
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/04/2019
Supplement Date Received by Manufacturer02/11/2019
Initial Report FDA Received Date01/22/2019
Supplement Report FDA Received Date02/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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