• 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. PRELUDESYNC¿.RADIAL COMPRESSION DEVICE

  • 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. PRELUDESYNC¿.RADIAL COMPRESSION DEVICE Back to Search Results
Catalog Number SRB24AC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pseudoaneurysm (2605)
Event Date 03/27/2019
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation. A review of the device history and complaint database could not be performed since the lot number was not provided.
 
Event Description
The account alleges that post-diagnostic angiogram, a radial hemostasis band was successfully placed. The nurse states that after 5 min within the post procedure recovery unit, the patient acquired a hematoma. The hematoma was treated with manual compression and the placement of a second radial compression band a little more proximal to first. The patient's condition worsened and a pseudoaneurysm was later identified. The patient underwent surgical repair for the pseudoaneurysm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRELUDESYNC¿.RADIAL COMPRESSION DEVICE
Type of DeviceRADIAL COMPRESSION DEVICE
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer Contact
katie swenson cqe,cba,cqpa.
1600 merit parkway
south jordan, UT 84095
8012531600
MDR Report Key8531372
MDR Text Key142483861
Report Number1721504-2019-00028
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K180723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSRB24AC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2019 Patient Sequence Number: 1
-
-