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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. - PEARLAND IMPRESS® CATHETER, INTRAVASCULAR, DIAGNOSTIC

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MERIT MEDICAL SYSTEMS, INC. - PEARLAND IMPRESS® CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 00884450009185
Device Problems Fracture (1260); Material Separation (1562)
Patient Problems Coma (2417); Foreign Body In Patient (2687)
Event Date 03/24/2021
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that the impress catheter tip broke off during a neurology vascular intervention. The tip of the catheter migrated along the vessel toward the brain. The patient was unconscious and comatose. An additional device was used to complete the procedure.
 
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Brand NameIMPRESS®
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC. - PEARLAND
14646 kirby drive
houston TX 77047
MDR Report Key11962101
MDR Text Key255125749
Report Number3010665433-2021-00038
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00884450009185
UDI-Public00884450009185
Combination Product (y/n)N
PMA/PMN Number
K053171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model Number00884450009185
Device Catalogue Number510035B2
Device Lot NumberE1578092
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2019
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: 06/08/2021 Patient Sequence Number: 1
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