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

Catalog Number 425-3022X

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2015

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 device separated.The target lesion was the superficial femoral artery and bk.The lesion was heavily calcified and moderately tortuous.The rate of stenosis was 100% (cto).An ipsilateral approach was made.The complaint device was attempted to be used however it was confirmed that the device separated.The procedure was completed successfully.It was reported that the device was not clinically used therefore there was no patient involvement and 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 not returned for evaluation.The result of the investigation is inconclusive as the complaint sample was not returned for evaluation.It was reported that the device separated.The complaint device was attempted to be used however it was confirmed that the device separated.It is possible that force may have been used when using the device causing the device to break.However based upon available information a definitive root cause has not been determined.It is possible that handling techniques may 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).Not returned.

Event Description

It was reported that the device separated.The device was handled according to the ifu.There was no damage noted to the box, pouch, hoop or balloon sleeve and there was no difficulty removing the device from the box, pouch or hoop.Reportedly the mandrel was not removed from the device and it is unknown if the balloon sleeve was removed.The target lesion was the superficial femoral artery and bk.The lesion was heavily calcified and moderately tortuous.The rate of stenosis was 100% (cto).An ipsilateral approach was made.The complaint device was attempted to be used however it was confirmed that the device separated.It is unknown if force was required when using the device and unknown if any kinks were noted on the device prior to use.The procedure was completed successfully.There was no patient involvement and 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: 5310152
• MDR Text Key: 34743172
• Report Number: 9616666-2015-00012
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 425-3022X
• Device Lot Number: 50117122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2014
• 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