• 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. MERIT MEDICAL PRECLUDE 7FR SHEATH 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. MERIT MEDICAL PRECLUDE 7FR SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number PSI7F23 038MT
Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problem Thrombosis (2100)
Event Date 06/19/2019
Event Type  malfunction  
Event Description
The radiopaque marker of the merit medical 7 fr sheath separated from the sheath during sheath removal. The radiopaque marker embolized in the patient popliteal artery leading to arterial thrombosis that required additional treatment. On (b)(6) 2019 patient require lysis and percutaneous extraction of the embolized radiopaque marker. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMERIT MEDICAL PRECLUDE 7FR SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
south jordan UT 84095
MDR Report Key10396153
MDR Text Key202752926
Report NumberMW5096021
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPSI7F23 038MT
Device Catalogue NumberIM1 0174/371836
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-