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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 425-2015X
Device Problem Material Rupture (1546)
Patient Problem No Information (3190)
Event Date 05/05/2017
Event Type  malfunction  
Manufacturer Narrative
It was reported that the balloon ruptured. The device was stored , handled and prepped according to the ifu. There were no anomalies noted when the device was removed from packaging. 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 prior to inserting the device into the patient. The device prepped normally. The target lesion was btk. The lesion was severely calcified and tortuous. The device was not used for cto. The rate of stenosis is unknown. The complaint device was delivered to the lesion with difficulty. The device was inflated however the balloon ruptured. The same indeflator was used successfully with other devices. The device was easily removed in one piece from the patient. The device was inserted into the patient once and was not inflated prior to the burst. Another device was used to complete the procedure 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 first event reported for this lot number and issue to date. The device was returned for evaluation. The returned sample arrived back twisted and kinked. No external or internal packing was returned. No sleeve was returned. The device arrived back with three severe bends on the hypotube and two severe kinks on the hypotube. The hub was printed as expected and no visual defects were observed. No visual defects were noted on the re-port. No visual defects were noted on the transition outer or outer. There was a severe bend on the hypotube under the strain relief. There were also three other bends on the hypotube. The first severe bend was approx. 32cm from the strain relief, the second was approx. 26cm from the strain relief and the third was approx. 79cm from the strain relief. It was also noted that there were two severe kinks on the inner. The first was noted just at the proximal markerband and the second was approx. 2cm from the distal tip. There was evidence of a small amount of dried substance noted on the proximal side of the balloon. There was no visual evidence of damage / material rupture noted on the balloon. No visual defects were noted to the distal tip or markerbands. Due to a severe kink on the inner just at the proximal markerband, as the guidewire might damage the inner while passing through the device, a decision was made to inflate the device without inserting the guidewire. The device was inflated with air to 6atm, and held pressure. A guidewire was then inserted through the distal tip and through the balloon section, as the guidewire reached the proximal bond location, resistance was felt and insertion of the guidewire was ceased. The device was again inflated with air to 6atm, and it maintained pressure. The device was inserted into a water bath to check for air bubbles, leaks, or material rupture. This test passed, no air bubbles/leaks/rupture was noted. The device was visually inspected under 4x-60x magnification by digital microscope camera. The evaluation did not confirm the reported failure mode of the device material rupture. The device preformed as intended during the functional evaluation. The result of the investigation is unconfirmed as the device functioned as expected during evaluation. Based upon the available information a definitive root cause has not been determined. As there were no kinks noted on the device prior to use and the device was not used on the patient it is likely that handling 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
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. Receipt of device is pending. The investigation is currently in progress. Not returned.
 
Event Description
It was reported that the balloon ruptured. The device was stored , handled and prepped according to the ifu. There were no anomalies noted when the device was removed from packaging. 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 prior to inserting the device into the patient. The device prepped normally. The target lesion was btk. The lesion was severely calcified and tortuous. The device was not used for cto. The rate of stenosis is unknown. The complaint device was delivered to the lesion with difficulty. The device was inflated however the balloon ruptured. The same indeflator was used successfully with other devices. The device was easily removed in one piece from the patient. The device was inserted into the patient once and was not inflated prior to the burst. Another device was used to complete the procedure 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 Key6639963
MDR Text Key196479116
Report Number9616666-2017-00028
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 07/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number425-2015X
Device Lot Number50121086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2015
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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