MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX; PTA BALLOON DILATATION CATHETER

Catalog Number 425-2512X

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2015

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.Receipt of the device is pending.The investigation is currently in progress.Not returned.

Event Description

It was reported that the tip separated from the device.The target lesion was the anterior tibial artery.The lesion was not calcified and was mildly tortuous.The rate of stenosis was 99%.The complaint device was removed from its packaging and was intended to be used for dilatation at the target lesion.During preparation the stylet was removed and the balloon sleeve and a needle were attempted to be removed to allow flushing of the guidewire lumen.However, the distal tip of the balloon and the shaft separated.Another device was used to complete the procedure successfully.There was no patient involvement and therefore 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 to date.The device was returned for evaluation.Evaluation of the returned sample identified that no external packaging returned, sleeve and shipping mandrel were returned.There were 4 kinks and 3 bends on the hypotube.The inner has detached from the device at the re-port and was stretched.The shipping mandrel was in the inner/balloon and was tightly held in position.The proximal bond had ruptured and the proximal marker band was outside of the balloon.A pinch mark was visible on the sleeve at 2 cm from the distal end.A functional evaluation was not possible due to the condition of the returned device.The reported failure of "tip separated from the device" is confirmed.The returned device has separated into 2 sections at the report.During preparation attempts were made to remove the balloon sleeve and shipping mandrel.However, the distal tip of the balloon and the shaft separated.It is unknown if pressure was applied at time of rupture.However, based upon the available information a definitive root cause cannot be determined.It is unknown whether handling or procedural techniques have contributed to the reported event.Based on trending 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).

Event Description

It was reported that the tip separated from the device.The device was stored, handled and prepped according to the ifu.There were no anomalies noted to the device or packaging and there was no difficulty removing the device from its packaging.The target lesion was the anterior tibial artery.The lesion was not calcified and was mildly tortuous.The rate of stenosis was 99%.The complaint device was removed from its packaging and was intended to be used for dilatation at the target lesion.During preparation the stylet was removed and the balloon sleeve and a needle were attempted to be removed to allow flushing of the guidewire lumen.However, the distal tip of the balloon and the shaft separated.It is unknown if force was required when handling the device.Another device was used to complete the procedure successfully.There was no patient involvement and therefore no patient injury reported.

• 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 ; moyne upper; enniscorthy, co. wexford ; EI ; 539237111
• MDR Report Key: 5067298
• MDR Text Key: 26031000
• Report Number: 9616666-2015-00007
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 425-2512X
• Device Lot Number: 50057021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR