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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTATIS INTRODUCER CATH-LOCK INTRODUCER; INTRODUCER, CATHETER
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ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTATIS INTRODUCER CATH-LOCK INTRODUCER; INTRODUCER, CATHETER Back to Search Results
Model Number 406962
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/04/2020
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 an atrial tachycardia ablation procedure, blood was leaking from the hemostasis valve of the green capped port.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.No additional puncture was required for this replacement.
 
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Brand Name
FAST-CATH TRIO HEMOSTATIS INTRODUCER CATH-LOCK INTRODUCER
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key10537393
Report Number3005334138-2020-00427
Device Sequence Number19500555
Product Code DYB
UDI-Device Identifier05414734204040
UDI-Public05414734204040
Combination Product (Y/N)N
Initial Reporter CountryJA
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
Report Date (Section B) 09/15/2020
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 Date10/31/2020
Device Model Number406962
Device Catalogue Number406962
Device Lot Number6227873
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 09/07/2020
Initial Report FDA Received Date09/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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