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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION; INTRAVASCULAR CATHETER
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CENTURION MEDICAL PRODUCTS CENTURION; INTRAVASCULAR CATHETER Back to Search Results
Model Number ECVC3545
Device Problem Crack (1135)
Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729)
Event Date 06/21/2016
Event Type  Injury  
Manufacturer Narrative
Multiple attempts to gather additional information from the initial reporter were unsuccessful.Nevertheless, it's unlikely the reported patient experience is attributable to the device itself.
 
Event Description
Patient experienced cardiac arrhythmia (afib) after the removal of a cracked catheter.
 
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Brand Name
CENTURION
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
CENTURION MEDICAL PRODUCTS
3310 s main st.
salisbury NC 28147
Manufacturer (Section G)
CENTURION MEDICAL PRODUCTS
3310 s main st.
salisbury NC 28147
Manufacturer Contact
matthew price
100 centurion way
williamston, MI 48895
5175451135
MDR Report Key5831101
MDR Text Key50713354
Report Number1038445-2016-00001
Device Sequence Number1
Product Code OES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/30/2017
Device Model NumberECVC3545
Device Lot Number2015111150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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