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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 406107
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/02/2020
Type of Reportable Event Serious Injury
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 incident could not be conclusively determined.
 
Event or Problem Description
During a procedure, it was noted to be difficult to insert the introducer into the patient and required an additional subclavian puncture to completed the procedure.There were no other adverse consequences to the patient.
 
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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 Key9971660
Report Number3005334138-2020-00162
Device Sequence Number2740533
Product Code DYB
UDI-Device Identifier05414734013819
UDI-Public05414734013819
Combination Product (Y/N)N
Initial Reporter CountryCO
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
Report Date (Section B) 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date05/31/2020
Device Model Number406107
Device Catalogue Number406107
Device Lot Number6044302
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/24/2020
Initial Report FDA Received Date04/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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