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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 Problems Arcing at Paddles (1032); Loss of or Failure to Bond (1068); Break (1069); Failure to Charge (1085); Computer Software Problem (1112); Continuous Firing (1123); Crack (1135); Material Discolored (1170); No Display/Image (1183); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Flaked (1246); Fluid/Blood Leak (1250); Fracture (1260); Material Fragmentation (1261); Material Frayed (1262); Labelling, Instructions for Use or Training Problem (1318); Inability to Irrigate (1337); Leak/Splash (1354); Mechanical Problem (1384); Melted (1385); Migration or Expulsion of Device (1395); Poor Quality Image (1408); Delivered as Unsterile Product (1421); Material Opacification (1426); Energy Output Problem (1431); Output above Specifications (1432); Pacing Problem (1439); Unsealed Device Packaging (1444); Pitted (1460); Failure to Power Up (1476); Off-Label Use (1494); Decreased Pump Speed (1500); Increased Pump Speed (1501); Failure to Pump (1502); Pumping Stopped (1503); Material Puncture/Hole (1504); Device Remains Activated (1525); Difficult to Remove (1528); Shipping Damage or Problem (1570); Stretched (1601); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Material Perforation (2205); Visual Prompts will not Clear (2281); Device Damaged Prior to Use (2284); Aborted Charge (2288); Arcing of Electrodes (2289); Incomplete or Missing Packaging (2312); Failure to Deliver (2338); Failure to Infuse (2340); Tear, Rip or Hole in Device Packaging (2385); Dull, Blunt (2407); Obstruction of Flow (2423); Failure to Calibrate (2440); Failure to Advance (2524); Misfire (2532); Arcing (2583); Delayed Charge Time (2586); Sparking (2595); Failure to Fire (2610); Battery Problem (2885); Calibration Problem (2890); Charging Problem (2892); Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896); Connection Problem (2900); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912); Device Sensing Problem (2917); Difficult to Advance (2920); Difficult to Open or Remove Packaging Material (2922); Expulsion (2933); Failure of Device to Self-Test (2937); Failure to Auto Stop (2938); Failure to Shut Off (2939); Infusion or Flow Problem (2964); Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981); No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004); Output Problem (3005); Packaging Problem (3007); Power Problem (3010); Pumping Problem (3016); Temperature Problem (3022); No Apparent Adverse Event (3189); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Device Handling Problem (3265); Wireless Communication Problem (3283); Migration (4003); Component Misassembled (4004); Material Too Soft/Flexible (4007); Firing Problem (4011); Complete Loss of Power (4015); Intermittent Loss of Power (4016); Unintended Electrical Shock (4018); Unexpected Shutdown (4019); No Visual Prompts/Feedback (4021); Intermittent Energy Output (4025)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. Reference (b)(4).
 
Event Description
An angiodynamics executive district sales manager reported an issue with an eximo atherectomy catheter. During a procedure, a 2. 0mm catheter was unable to cross the stented bifurcation, with a spartacore wire and destination sheath. The doctor then opted to use a 1. 5mm catheter at 50mj one time and 60mj 3 times. The total laser time was 5 minutes. When the catheter was pulled out of the patient, the silver blade tip was missing. The tip was in the patient, on the wire. The doctor placed a supera stent (2 total) to secure the tip against the wall of the sfa, where it will remain. The patient did not experience any adverse effects or harm as a result of this incident and the procedure was completed with a good result. The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
 
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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
dr. yossi muncher
3 pekeris street
building 2, suite 270
science park, rehovot 76702-03
IS   7670203
MDR Report Key11075823
MDR Text Key223718016
Report Number1319211-2020-10015
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
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEXM-4001-0000
Device Lot Number41272CO06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
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: 12/28/2020 Patient Sequence Number: 1
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