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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE IDEAL¿ INTRODUCER, CATHETER

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MERIT MEDICAL SYSTEMS, INC. PRELUDE IDEAL¿ INTRODUCER, CATHETER Back to Search Results
Model Number 10884450381868
Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2022
Event Type  malfunction  
Event Description
Early 50¿s male with history of chest pain and suspected coronary heart disease. Procedure: left and right coronary heart catheterization. First sheath dilatator kinked when used, 2nd sheath would not go over the first one. All removed without known harm to patient. New access with third sheath that was successful. Minor delay in procedure. Manufacturer response for introducer, catheter, prelude ideal (per site reporter) will obtain. Manufacturer response for introducer, catheter, prelude ideal (per site reporter) will obtain.
 
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Brand NamePRELUDE IDEAL¿
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 west merit parkway
south jordan UT 84095
MDR Report Key14884899
MDR Text Key295128161
Report Number14884899
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00884450381861
UDI-Public(01)00884450381861(17)250416(10)H2400580
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10884450381868
Device Catalogue NumberPID6F11021SSC/A
Device Lot NumberH2400580
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2022
Event Location Hospital
Date Report to Manufacturer07/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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