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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 Material Fragmentation (1261); Difficult to Remove (1528); Material Rupture (1546)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/18/2017
Event Type  malfunction  
Manufacturer Narrative
It was reported that the balloon ruptured on the second inflation. There was no difficulty removing the device from the hoop and no difficulty removing the balloon sleeve or mandrel. There were no kinks or damage noted on the device prior to use. The device prepped normally. The target lesion was the superficial femoral artery and the below knee. The patient¿s vessel level of tortuousness was unknown. The lesion was heavily calcified. The rate of stenosis was unknown. The complaint device was delivered to the lesion. The device was inflated in the heavily calcified part of the lesion however the balloon ruptured during the second inflation. The device was removed in one piece from the patient. It is unknown how the procedure was completed but the procedure finished successfully. There was no patient injury reported. 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 second reported complaint for this lot number and issue to date. The result of the investigation for the first complaint was inconclusive as the sample was not returned for evaluation. For this complaint the device was not returned for evaluation. The result of the investigation is inconclusive as complaint device was not returned for evaluation. The event description outlined that the balloon ruptured on the second inflation. Therefore it inflated successfully on the first attempt. Based upon the available information a definitive root cause has not been determined. It is unknown if patient factors i. E. Heavy calcification of the lesion, handling or procedural techniques may have contributed to the reported event. 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 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. 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).
 
Manufacturer Narrative
Receipt of device is expected. The investigation is currently in progress. Not returned.
 
Event Description
It was reported that the balloon ruptured on the second inflation. There was no difficulty removing the device from the hoop and no difficulty removing the balloon sleeve or mandrel. There were no kinks or damage noted on the device prior to use. The device prepped normally. The target lesion was the superficial femoral artery and the below knee. The patient¿s vessel level of tortuousness was unknown. The lesion was heavily calcified. The rate of stenosis was unknown. The complaint device was delivered to the lesion. The device was inflated in the heavily calcified part of the lesion however the balloon ruptured during the second inflation. The device was removed in one piece from the patient. It is unknown how the procedure was completed but the procedure finished successfully. There was no patient injury reported.
 
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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 Key6954341
MDR Text Key265233731
Report Number9616666-2017-00101
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 11/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number425-2004X
Device Lot Number50136832
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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