• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EXIMO MEDICAL LTD. CATHETER EXIMO ATHERECTOMY PERIPHERAL ATHERECTOMY CATHETER, Back to Search Results
Catalog Number EXM-4003-0000
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2020
Event Type  malfunction  
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 district sales manager reported an issue with a 2. 0mm eximo atherectomy catheter. The device was used in a 6f cook sheath and sheared off a long and large section of the sheath. This was noted after the device was removed between treatments. The procedure was completed with a 1. 5mm device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident. It was indicated the reported device is available for return to the manufacturer for a device evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
dr. yossi muncher
3 pekeris street
building 2, suite 270
science park, rehovot 76702-03
IS   7670203
MDR Report Key11182954
MDR Text Key256116439
Report Number1319211-2021-10002
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 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEXM-4003-0000
Device Lot NumberUNKNOWN
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 Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-