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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 Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
Event Type  malfunction  
Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
 
Event Description
An end user reported an issue with a 1.5mm auryon atherectomy laser catheter.A 7f sheath was used during the procedure because a 2.35mm catheter was used prior to the 1.5mm in another segment of the artery.The wire used was a boston scientific v-14.The lesion being treated was mostly soft plaque located approximately 80mm in the femoral popliteal.During lasing, the energy used was 50mj for approximately 2.25 minutes.The physician was backing the catheter out over the wire when lasing was completed, and at a certain point, it stopped moving over the wire.At that point, he needed to pull the wire and catheter out together as a unit.They were essentially married to each other.After it was removed from the patient, the angiodynamics executive district sales manager inspected the device and it appeared that the tip/blade of the catheter melted off and was stuck to the wire.The entire tip of the catheter was also reported to appear as if it was burnt.There was no evidence of a burning smell or smoke.It was believed the blade had separated from the catheter but welded itself to the wire.There was no report of the patient experiencing 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.
 
Manufacturer Narrative
Returned for evaluation was a 1.5mm auryon catheter.The catheter complaint sample was forwarded to eximo facility for evaluation.The catheter arrived with the outer jacket, peeled in one location, and fibers exposed and broken.The distal tip had tissue remaining at the outer tip (stainless steel tube), over the fibers and between the guidewire and the inner lumen of the catheter (the guidewire lumen).The guidewire was stuck inside the catheter and was unable to be removed.The rfid tag was read and working time was recorded as 215 seconds at 50mj/mm2 and 0 seconds at 60mj/mm2; hence, no lasing was done at all.No manufacturing non-conformances were observed during sample evaluation.A review of the distribution records was performed for the reported packaging lot number 49675 for any deviations related to the reported failure mode of the complaint.The review confirms that the lot met all packaging performance specifications; i.E.No ncr written.Complaint event was forwarded to laser catheter manufacturer (eximo).Eximo performed a dhr review of the reported catheter lot number 49675.The review confirmed that the lot met all material, assembly and performance specifications, e.G.No manufacturing non-conformance reports were issued.The customer's reported complaint description of catheter tip was melted was not confirmed based on visual inspection of the returned sample.The catheter had tissue impacted at the tip but it was not melted.It was confirmed that guidewire was stuck inside the catheter lumen and guidewire could not be removed.The tip was intact, and the guidewire was stuck probably due to tissue residues covering the tip of the catheter and/or a kink in the guidewire.It was reported that the guidewire and catheter had to be pulled out together as a unit.The catheter also presented with a torn outer jacket and broken fibers that is likely due to a kinked guidewire and excessive force used in trying to withdraw the catheter over the guidewire.The root cause for the event was determined to be handling damage by the end user.Labeling review: instructions for use is provided with the catheter device and contain the following statements: warnings: pay careful attention while using the catheter, avoid excessive force and be on alert for any potential damage.Inadvertent movement of the catheter may result in patient injury.Always use fluoroscopic surveillance when advancing the auryon catheter inside the patient vasculature to avoid misplacement, dissection, or perforation.Auryon catheter insertion over the wire until laser activation: you may use any other gw to cross the lesion, but the final gw that auryon catheters will track over should be 300cm 0.014", and preferably stiff gws.Once this gw is angiographically verified to cross the lesion in the vessel's lumen, it is ready for auryon catheter insertion over the wire.Advancement of auryon catheter through the lesion: a) do not to exceed 10 seconds of lasing at the same location.If you experience any difficulty to advance the auryon catheter, immediately start self-count-down.Self-count-down should start the moment you experience non-advancement of the auryon catheter.When advancement resumes, you should stop self-count-down and resume it if additional non-advancements are experienced.B) if the auryon catheter cannot be advanced by the 10th second of laser activation, you should release the foot switch to stop the laser, retract the catheter approximately 3-4 mm, and try to advance again while rotating the catheter shaft approximately 90 degrees to either side, while resuming 10 seconds count down.C) if the auryon catheter is still not advancing with the above-mentioned rotation manipulation for the additional 10-seconds, immediately stop the laser activity by releasing the footswitch.D) ask the laser operator to raise the fluence to the 60mj/mm2.E) activate the laser and try again to advance the auryon catheter through the lesion.F) if the auryon catheter cannot be advanced, resume the self-count-down to 10 seconds.G) if the auryon catheter cannot be advanced in this attempt, stop the laser activity, withdraw the auryon catheter and use a new catheter.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference: (b)(4).
 
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Brand Name
CATHETER EXIMO ATHERECTOMY
Type of Device
PERIPHERAL 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 Key12688374
MDR Text Key278102370
Report Number1319211-2021-10020
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 User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/10/2023
Device Catalogue NumberEXM-4001-0000
Device Lot Number49675
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age50 YR
Patient SexFemale
Patient Weight44 KG
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