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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER
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ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER Back to Search Results
Model Number 406104
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/04/2019
Type of Reportable Event Malfunction
Event or Problem Description
During an infropopliteal angioplasty, there was blood leaking out of the introducer.The procedure was completed.
 
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported leak remains unknown.
 
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Brand Name
FAST-CATH HEMOSTASIS INTRODUCER
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key8808251
Report Number3005334138-2019-00399
Device Sequence Number326814
Product Code DYB
UDI-Device Identifier05414734008242
UDI-Public05414734008242
Combination Product (Y/N)N
Initial Reporter CountryMX
PMA/510(K) Number
K914090
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) 08/02/2019
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 Date10/31/2020
Device Model Number406104
Device Catalogue Number406104
Device Lot Number6222844
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/05/2019
Supplement Date Received by Manufacturer07/23/2019
Initial Report FDA Received Date07/19/2019
Supplement Report FDA Received Date08/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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