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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER
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PLEXUS MANUFACTURING SDN. BHD CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number 106A3
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/07/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The temperatures were not dropping properly.The case ended up being aborted and the patient was under general anesthesia.No patient complications have been reported as a result of this event.
 
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Brand Name
CRYOCONSOLE
Common Device Name
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY  11900
MDR Report Key6365031
Report Number3004593495-2017-00115
Device Sequence Number913594
Product Code LPB
UDI-Device Identifier00643169352476
UDI-Public00643169352476
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P020045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number106A3
Device Catalogue Number106A3
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/07/2017
Initial Report FDA Received Date02/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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