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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 425-2004X
Device Problems Kinked (1339); Failure to Advance (2524)
Patient Problem Blood Loss (2597)
Event Date 01/19/2017
Event Type  Injury  
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 has been received. The investigation is currently in progress.
 
Event Description
It was reported that the device failed to advance and became kinked. The device prepped normally. 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 right anterior tibial artery. The target lesion was heavily calcified and moderately tortuous. The rate of stenosis was unknown. A parent, medikit introducer sheath was used. A 0. 014 rubyhard guidewire and a prominent, tokai medical micro catheter were inserted into the patient and crossed the lesion. The complaint device was then inserted and advanced however the device failed to cross the lesion. An attempt was made to push the device in order to cross the lesion however this was unsuccessful. It is unknown if excessive force was used to attempt to cross the lesion. It is unknown if the device was easily removed however the device was removed in one piece from the patient. Once removed it was confirmed that the shaft guidewire exit side was kinked in several places. Furthermore, when the lesion was checked under contrast, bleeding to the extravascular was confirmed from around the exit part of the 4. 5f introducer sheath. As the physician had tried to cross the lesion several times it was reported that the kinked part of the device had stuck in the blood vessel and caused bleeding. It is unknown how many times the device was inserted into the patient and inflated. It is unknown how the bleeding was stopped however the physician stopped the bleeding and the procedure was completed using another device. It is unknown how much blood was lost and unknown if any treatment was provided for the blood loss. Due to the failure with the complaint device the procedure was prolonged by 40 minutes. The status of the patent is unknown.
 
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. It was reported that the device failed to advance and became kinked. The device prepped normally. 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 right anterior tibial artery. The target lesion was heavily calcified and moderately tortuous. The rate of stenosis was unknown. A parent, medikit introducer sheath was used. A 0. 014 rubyhard guidewire and a prominent, tokai medical micro catheter were inserted into the patient and crossed the lesion. The complaint device was then inserted and advanced however the device failed to cross the lesion. An attempt was made to push the device in order to cross the lesion however this was unsuccessful. It is unknown if excessive force was used to attempt to cross the lesion. It is unknown if the device was easily removed however the device was removed in one piece from the patient. Once removed it was confirmed that the shaft guidewire exit side was kinked in several places. Furthermore, when the lesion was checked under contrast, bleeding to the extravascular was confirmed from around the exit part of the 4. 5f introducer sheath. As the physician had tried to cross the lesion several times it was reported that the kinked part of the device had stuck in the blood vessel and caused bleeding. It is unknown how many times the device was inserted into the patient and inflated. It is unknown how the bleeding was stopped however the physician stopped the bleeding and the procedure was completed using another device. It is unknown how much blood was lost and unknown if any treatment was provided for the blood loss. Due to the failure with the complaint device the procedure was prolonged by 40 minutes. The status of the patent is unknown. 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. No external or internal packing was returned. The hub was printed as expected and no visual defects were observed. There was evidence of a deep squeezed impression noted on the proximal side of the re-port. There was a minor bend noted in the hypotube approx. 40 mm from the start of the hypotube. There were six deep impressions approx. 6/7 mm distance between each other, from the re-port to the hypotube side. No visual defects were noted on the transition outer or distal tip. There were six minor bends on the shaft. There is evidence of clear liquid found in the balloon towards the distal markerband. A 0. 014 guidewire was inserted through the hub of the device. The guidewire passed through successfully. The device was inflated and held pressure at 6 atm and deflated without any issue. The result of the investigation is inconclusive for the reported failure mode of 'failing to advance'. However the evaluation observed deep impressions along the hypotube which may have been the cause of the tractability problems reported. It is likely that this hypotube damage was the direct result from the several unsuccessful attempts the physician made to cross the heavily calcified lesion. Based on analysis performed no additional action is required at this time. The ifu states: 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 304 v 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. Indications: 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. Warnings: reuse, resterilization, reprocessing and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. Precautions: carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. If the hypotube kinks prior to or during use the catheter should be discarded. No attempt should be made to straighten a kink in the hypotube. Storage: store in a cool, dark, dry place. Use the catheter prior to the ¿use by¿ date specified on the package. Directions for use: inspection and preparation: 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. Deflation and withdrawal simultaneously withdraw the dilatation catheter and guidewire from the guiding catheter/sheath. As the balloon exits the vessel, use a smooth, gentle, steady, motion. If resistance is felt upon removal then the balloon, guidewire and the guiding catheter/sheath should be removed together as a unit under fluoroscopic guidance, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon catheter and guiding catheter/sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction. (b)(4).
 
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Brand NameSLEEK RX
Type of DevicePTA 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 Key6353003
MDR Text Key68141544
Report Number9616666-2017-00006
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
Type of Report Initial,Followup
Report Date 01/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Catalogue Number425-2004X
Device Lot Number50114062
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2014
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: 02/23/2017 Patient Sequence Number: 1
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