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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXIMO MEDICAL LTD. AURYON LASER SYSTEM 100-120 VAC

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EXIMO MEDICAL LTD. AURYON LASER SYSTEM 100-120 VAC Back to Search Results
Model Number EXM-2001-1100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Vomiting (2144); Diminished Pulse Pressure (2606)
Event Date 06/28/2021
Event Type  Death  
Manufacturer Narrative
The auryon unit (serial number (b)(4)) is not returning to the manufacturer for evaluation at this time as there was no allegation of malfunction during this event. The investigation for this adverse event is in process. The results of the investigation will be sent via a follow up medwatch. Reference (b)(4).
 
Event Description
An angiodynamics' clinical specialist reported that during an atherectomy procedure, while utilizing a 100-120 vac eximo atherectomy laser system at an end user facility, the patient complained of chest pain and it was observed that the patient's blood pressure appeared to be low. At that time, the physician stopped the procedure to assess the patient. During assessment, the patient vomited, coded, and ultimately expired. The end user physician and clinical specialist reported that there was no allegation of product deficiency or malfunction on or against the machine or any angiodynamics' device(s). Additional information regarding the patient and the event, including medical records and the death certificate were requested, but not provided by the end user. The laser system is not available to be returned to the manufacturer for physical evaluation.
 
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Brand NameAURYON LASER SYSTEM 100-120 VAC
Type of DeviceAURYON LASER SYSTEM 100-120 VAC
Manufacturer (Section D)
EXIMO MEDICAL LTD.
3 pekeris street
glens falls, ny 12801, rehovot 76702 03
IS 7670203
Manufacturer (Section G)
EXIMO LTD.
3 pekeris street
building 2, suite 270
science park, rehovot 76702 03
IS 7670203
Manufacturer Contact
yoel zabar
3 pekeris street
building 2, suite 270
science park, rehovot 76702-03
IS   7670203
MDR Report Key12176921
MDR Text Key261809854
Report Number1319211-2021-10015
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEXM-2001-1100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/15/2021 Patient Sequence Number: 1
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