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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FAST-CATH¿; INTRODUCER, CATHETER
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ST. JUDE MEDICAL, INC. FAST-CATH¿; INTRODUCER, CATHETER Back to Search Results
Model Number 406137
Device Problems Crack (1135); Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2019
Event Type  malfunction  
Event Description
Patient called complaining of "iv leaking" about 15 minutes after clinicians were at the bedside.Discovered iv tubing broken/disconnected from infusion port of sheath (pulmonary artery (pa) line).The exposed port was covered and the fellow came immediately to the bedside.No harm to patient.Pa line was then pulled without incident.Side port was also noted to be cracked.Manufacturer response for fast-cath hemostasis introducer (8.5fr), fast-cath hemostasis introducer (8.5fr) (per site reporter).The manufacturer stated they would perform an investigation on the product and our remaining shelf stock.
 
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Brand Name
FAST-CATH¿
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
100 abbott park road
abbott park IL 60064
MDR Report Key8424147
MDR Text Key138909203
Report Number8424147
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number406137
Device Catalogue Number406137
Device Lot Number6671878
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/27/2019
Event Location Hospital
Date Report to Manufacturer03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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