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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PROGUIDE CHRONIC DIALYSIS CATHETER
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MERIT MEDICAL SYSTEMS INC. PROGUIDE CHRONIC DIALYSIS CATHETER Back to Search Results
Model Number 00884450023426
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the catheter be returned later, the investigation will be re-opened.
 
Event or Problem Description
The account alleges that the hub on the chronic dialysis catheter was cracked and leaking.
 
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Brand Name
PROGUIDE CHRONIC DIALYSIS CATHETER
Common Device Name
CHRONIC DIALYSIS CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan,, ut
MDR Report Key10171724
Report Number1721504-2020-00041
Device Sequence Number13867927
Product Code MSD
UDI-Device Identifier00884450023426
UDI-Public00884450023426
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K090148
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/28/2022
Device Model Number00884450023426
Device Catalogue NumberDC21452419/CNA
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/20/2020
Initial Report FDA Received Date06/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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