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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER
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ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER Back to Search Results
Model Number 406955
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/24/2021
Type of Reportable Event Malfunction
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 paroxysmal supraventricular tachycardia ablation procedure, a blood leak was noted from the hemostasis valve of the introducer.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
 
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Brand Name
FAST-CATH TRIO HEMOSTASIS INTRODUCER
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key11919583
Report Number3005334138-2021-00357
Device Sequence Number14309098
Product Code DYB
UDI-Device Identifier05414734203999
UDI-Public05414734203999
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K061015
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/02/2021
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 Number406955
Device Catalogue Number406955
Device Lot Number7190974
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 05/24/2021
Initial Report FDA Received Date06/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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