MAUDE Adverse Event Report: CLEAR STREAM TECHNOLOGIES, LTD. SLEEK OTW

Catalog Number 426-5012X

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Type  malfunction  

Manufacturer Narrative

The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.Receipt of the device is pending.The investigation is currently in progress.

Event Description

It was reported that the device was slow to inflate and deflate.The target lesion was an unknown endovascular lesion.There was no pt 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 not returned for evaluation.The result of the investigation is inconclusive as the sample was not returned for evaluation.It was reported that the device was slow to inflate and deflate.However, based upon the available information 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: warnings: do not exceed the rated burst pressure.A syringe with pressure gauge is recommended to monitor pressure.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Use the catheter prior to the ¿use by¿ date specified on the package.Do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action.Precautions: if resistance is felt upon removal, then the balloon, guidewire and the sheath/guide catheter should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction.Before removing catheter from sheath/guide catheter it is very important that the balloon is completely deflated.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.Directions for use: inspection and preparation 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%) procedure: insertion and inflation procedure: note: a 0.014' (0.356 mm) guidewire must be inserted in the sleek® otw catheter across the balloon during any inflation of the balloon.Make sure that the balloon sleeve has been removed from the catheter balloon.Enter the vessel percutaneously using the standard seldinger technique over the appropriate guidewire for the size catheter being used.Advance the catheter across the lesion with fluoroscopic guidance using accepted percutaneous transluminal angioplasty technique and inflate the balloon to the appropriate pressure.Note: do not inflate the balloon or advance the catheter unless the guidewire is in place.Deflation and withdrawal deflate the balloon by drawing a vacuum with a 20 ml or larger syringe.Note: the larger the syringe diameter, the greater the suction that is applied.For maximum deflation a 50 ml syringe is recommended.Gently withdraw the catheter.As the balloon exits the vessel, use a smooth, gentle, steady, counterclockwise motion.If resistance is felt upon removal then the balloon and the 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 sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous vascular procedures.Warning: after use this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable local, state and federal laws and regulations.(b)(4).

Event Description

It was reported that the device was slow to inflate and deflate.There were no anomalies noted during the prep of the device.There was no difficulty removing the balloon sleeve and there were no kinks noted on the device prior to use.The target lesion was superficial femoral artery and the lesion was 120mm in length.A 0.014 guidewire was used.An inflation device was used to inflate the complaint device however reportedly the balloon inflated and deflated slower than usual.The device was inserted into the patient once and inflated once.The patient did not experience any complications as a result of the failure and there was no patient injury reported.

• Brand Name: SLEEK OTW
• Manufacturer (Section D): CLEAR STREAM TECHNOLOGIES, LTD.; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: fiona nimhullain ; moyne upper, enniscorthy; county wexford ; EI ; 539237111
• MDR Report Key: 4987663
• MDR Text Key: 23352409
• Report Number: 9616666-2015-00004
• Device Sequence Number: 1
• Product Code: LII
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 426-5012X
• Device Lot Number: 50115759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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