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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 EXM40040000
Device Problem Crack (1135)
Patient Problem Blood Loss (2597)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
The reported device has been returned to the manufacturer for a device evaluation. An investigation into the root cause for product problem is in process. The results of the investigation will be sent in a supplemental medwatch report reference (b)(4).
 
Event Description
An angiodynamics district sales manager reported an issue with a 2. 35mm eximo atherectomy catheter. The physician elected to use the 2. 35mm catheter, over a spartacore wire, as the patient had large vessels with soft plaque. Difficulty was experienced going over the bifurcation and a 7fr cook sheath was inserted, requiring extra force to be exerted in order to advance the catheter. The physician performed two full runs down the superficial femoral artery (sfa), at 50mj, for approximately 1:40 each. During this time, the unit displayed a "sensory error" message on 3 occasions and the catheter had to be unplugged and the unit was restarted. Once two runs were completed, the physician withdrew the device and took a picture of the vessel. Based on the picture, he did not feel that the device had accomplished a lot, so he determined to reinsert the catheter into the patient in order to treat the lesions again. At this time, prior to reinserting the catheter into the patient, the scrub tech was unable to locate the guidewire lumen in the 2. 35 catheter. The patient was immediately scanned to ensure that the blade did not detach from the catheter. The scan determined that the blade was not inside of the patient's arteries. The catheter was examined, and it was noticed that approximately 3-4 inches from the tip of the catheter, there was a significant crack in the plastic, with metal exposed. It was determined that the blade and wire lumen retracted inside of the catheter. The physician decided to open and utilize a 2. 0mm auryon catheter to complete the procedure. There were no issues with this catheter; however, there was a significant amount of blood collected in the aspiration catheter, totaling around 700ml. The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident. The reported device has been 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
dr. yossi muncher
3 pekeris street
building 2, suite 270
science park, rehovot 76702-03
IS   7670203
MDR Report Key10121058
MDR Text Key199719733
Report Number1319211-2020-10006
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 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEXM40040000
Device Lot NumberEXO017AR53
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
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: 06/04/2020 Patient Sequence Number: 1
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