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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. CRITICATH¿ PA CATHETER PULMONARY ARTERY CATHETER

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MERIT MEDICAL SINGAPORE PTE LTD. CRITICATH¿ PA CATHETER PULMONARY ARTERY CATHETER Back to Search Results
Catalog Number 680016/JPA
Device Problem Insufficient Information (3190)
Patient Problem Perforation of Vessels (2135)
Event Date 02/24/2021
Event Type  Injury  
Manufacturer Narrative
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that a pulmonary artery was perforated during the procedure. The account does not believe the device malfunctioned and/or was responsible for the adverse event.
 
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Brand NameCRITICATH¿ PA CATHETER
Type of DevicePULMONARY ARTERY CATHETER
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN 768926
MDR Report Key11593056
MDR Text Key243104594
Report Number8020616-2021-00013
Device Sequence Number1
Product Code DQO
UDI-Device Identifier04589731120592
UDI-Public4589731120592
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/02/2022
Device Catalogue Number680016/JPA
Device Lot NumberC1928148
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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