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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX; PTA BALLOON DILATATION CATHETER
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CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX; PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 425-2522X
Device Problems Difficult to Remove (1528); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2016
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was received.The investigation is currently in progress.Investigation is on-going.
 
Event Description
It was reported that the device became stuck on the guidewire and could not be removed from the patient.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve and there was no difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The target lesion was the right superficial femoral artery to bk.The lesion was moderately calcified and not tortuous.The rate of stenosis was 99%.An ipsilateral contralateral approach was made.The superficial femoral artery was diffused.After pre-dilation was performed, two smart stents were placed at the lesion.After that treatment was shifted to the bk.A sheathless pv, asahi intecc guiding catheter was delivered to the popliteal artery.A guidewire was advanced and crossed the lesion.The complaint device was then delivered to the anterior tibial artery and inflated.The device was attempted to be removed however the device became stuck in the guidewire.The physician attempted to remove the device by force however the device could not be removed.The device did not separate or break into two or more pieces at any time during the procedure.Finally the device was removed in one piece from the patient reportedly by 'main force'.It is unknown how many times the device was inserted into the patient and inflated and unknown if kinks were noted during or after use.An ultraverse medicon device was then used to complete the procedure successfully.There was no patient injury reported.
 
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the first event reported for this lot number and issue to date.The device was returned for evaluation.Evaluation of the returned sample identified that there were numerous kinks and bends observed on the hypotube.Numerous kinks and bends were observed on the outer and inner.The device was returned with the catheter tied in a knot around the hub and the balloon wrapped around the hub a 0.014 guidewire was inserted through the re-port without issue.The device was inflated and deflated without any fault to 6atm and held pressure.The result of the investigation is inconclusive.Based upon the available information and investigation a definitive root cause cannot be determined.It is unknown whether patient factors or procedural techniques may have contributed to the reported event.Based on trending analysis performed no additional action is required at this time.The ifu states: device description: the sleek® percutaneous transluminal angioplasty (pta) peripheral catheter; family comprise a range of sizes of rapid exchange catheters for peripheral angioplasty.The catheter¿s proximal tubing is 304v stainless steel and the distal coaxial tubings are nylon co-polymer blend.The lumen of the shaft is used for the purpose of inflating and deflating the balloon.A second lumen at the tip is used for advancing the guidewire.To locate the balloon under fluoroscopy platinum iridium marker bands are provided at the shoulders of the balloon for all sizes.The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles.The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon.The silx¿ coating is a silicone coating which provides improved lubricity to the balloon shaft.A 0.014¿ (0.356 mm) guidewire is recommended for use with the sleek® catheters.Indication for use: the sleek® catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.These catheters are not designed to be used in the coronary arteries.Directions for use: remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible.If any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used.The catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.Prepare a mixture of contrast medium and normal saline as per normal procedure.(recommended 25%/75%) attach a stopcock and a 20 ml syringe half filled with the contrast solution to the balloon port.Point the syringe nozzle downward and aspirate until all air is removed from the balloon.Turn the stopcock off and maintain the vacuum in the balloon.Purge the catheter through lumen thoroughly.Reinserting the balloon into the balloon sleeve may damage the balloon or catheter.(b)(4).
 
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Brand Name
SLEEK RX
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI  
Manufacturer Contact
fiona nimhullain
539237111
MDR Report Key5606639
MDR Text Key44481343
Report Number9616666-2016-00006
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Catalogue Number425-2522X
Device Lot Number50123629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2016
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received04/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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