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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDESYNC CLAMP, VASCULAR

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MERIT MEDICAL SYSTEMS, INC. PRELUDESYNC CLAMP, VASCULAR Back to Search Results
Model Number 10884450363659
Device Problem Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 11/22/2021
Event Type  malfunction  
Event Description
Doctor and tech applied distal synch band to left distal radial artery for occlusion, when checked, noted no air in the band. When band is applied, air is put in a pillowed area on the band to apply pressure to the artery. Manufacturer response for hemostasis band, prelude sunc. Distal (per site reporter). Manufacturer sales rep was made aware. He removed the remaining inventory of bands involved with the lot number.
 
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Brand NamePRELUDESYNC
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 west merit parkway
south jordan UT 84095
MDR Report Key13076534
MDR Text Key282722371
Report Number13076534
Device Sequence Number1
Product Code DXC
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 11/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10884450363659
Device Catalogue NumberSDRB-REG-RT
Device Lot Number2220120
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2021
Event Location Hospital
Date Report to Manufacturer12/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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