• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERIT MEDICAL SYSTEMS, INC. PRELUDE IDEAL INTRODUCER, CATHETER Back to Search Results
Model Number 10884450381868
Device Problems Difficult to Insert (1316); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 03/31/2021
Event Type  malfunction  
Event Description
A (b)(6) patient with a history of coronary artery disease underwent a diagnostic heart catheterization. During the procedure, 6f prelude ideal hydrophilic sheath would not pass over the introducer wire due to a defect inside the inner dilator blocking the wire during its insertion. Another device was used for the procedure. Please note this is the 3rd incident with the prelude ideal¿ with the same complaint. Please refer to reports (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRELUDE IDEAL
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 west merit parkway
south jordan UT 84095
MDR Report Key11607129
MDR Text Key243597848
Report Number11607129
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 Risk Manager
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2021
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 NumberH2032401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2021
Event Location Hospital
Date Report to Manufacturer04/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-