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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 406143
Medical Device Problem Code Component Misassembled (4004)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/12/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Recall number: 3005334138-12/5/2019-002-r.The investigation revealed that an 8f dilator and 8f sheath were packaged within the 8.5f fast-cath hemostasis introducer package.
 
Event or Problem Description
Prior to the procedure, the sheath was noted to be an 8fr, when the packaging read 8.5fr.Eleven sheaths were returned unopened.
 
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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 Key9500371
Report Number3005334138-2019-00729
Device Sequence Number19133327
Product Code DYB
UDI-Device Identifier05414734014212
UDI-Public05414734014212
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K914090
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 12/19/2019
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 Date03/31/2022
Device Model Number406143
Device Catalogue Number406143
Device Lot Number6950628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/22/2019
Initial Report FDA Received Date12/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		SEE H10
Patient Sequence Number1
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