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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXIMO MEDICAL LTD. CATHETER EXIMO ATHERECTOMY PERIPHERAL ATHERECTOMY CATHETER

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EXIMO MEDICAL LTD. CATHETER EXIMO ATHERECTOMY PERIPHERAL ATHERECTOMY CATHETER Back to Search Results
Catalog Number EXM-4001-0000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 06/10/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation. The results of the investigation will be sent via a follow up medwatch. Reference (b)(4).
 
Event Description
An angiodynamics executive sales manager reported a customer experienced an issue when using a 1. 5mm auryon catheter yesterday ((b)(6) 2021). A galdius mongo es wire was used for the procedure. Dr. (b)(6) treated a long 20cm sfa lesion with a 1. 5 catheter. It was lased on 50mj; 1:13 & 1:10 minutes, and 60mj for :43 seconds & 1:01 minutes, for a total lase time of 4:07 minutes. After treating, it was noticed a dissection. Ivus confirmed the dissection flap. He ballooned and stented with a saber 6. 0x100 balloon post with a great end result in the sfa. The gladius mongo wire had also caused a perforation in the popliteal where the tip of the wire was placed. A viabahn stent was placed in the popliteal. He did not lase the popliteal. It was reported post procedure, the patient was doing well and the dissection resolved after placing stents. It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.
 
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Brand NameCATHETER EXIMO ATHERECTOMY
Type of DevicePERIPHERAL ATHERECTOMY CATHETER
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 Key12100636
MDR Text Key259433980
Report Number1319211-2021-10012
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
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEXM-4001-0000
Device Lot Number47581
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 Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2020
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: 07/01/2021 Patient Sequence Number: 1
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