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

Catalog Number UNKNOWN SLEEK OTW

Device Problems Deflation Problem (1149); Material Separation (1562); Device Operates Differently Than Expected (2913)

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

Event Date 03/07/2017

Event Type  Injury  

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.

Event Description

It was reported that the device failed to deflate.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 use.The device prepped normally.The intended treatment site was the superficial femoral artery and the popliteal arteries.The lesion was heavily calcified and tortuous.The rate of stenosis was no more than 90%.A sleek device was used however the balloon failed to deflate and the shaft of the device separated.Reportedly after the separation of the shaft the balloon finally deflated but did not completely deflate.The complaint device was then used.The device was inserted and advanced to the lesion with difficulty.The device was inflated in an effort to reportedly trap the shaft of the distal piece of the fractured balloon.The most proximal part of the balloon was in the sheath when inflated to try and trap the fractured part of the sleek device used to remove it.The device then failed to deflate.The balloon was poked with the back end of an interventional wire in order to deflate the balloon.The type and brand of inflation device used is unknown and this device was not used successfully with other devices.The device was never in an acute bend.The maximum inflation pressure is unknown.There were no adverse consequences to the patient as a result of the failure with the device.There was 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.It was reported that the device failed to deflate.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 use.The device prepped normally.The intended treatment site was the superficial femoral artery and the popliteal arteries.The lesion was heavily calcified and tortuous.The rate of stenosis was no more than 90%.A sleek device was used however the balloon failed to deflate and the shaft of the device separated.Reportedly after the separation of the shaft the balloon finally deflated but did not completely deflate.The complaint device was then used.The device was inserted and advanced to the lesion with difficulty.The device was inflated in an effort to reportedly trap the shaft of the distal piece of the fractured balloon.The most proximal part of the balloon was in the sheath when inflated to try and trap the fractured part of the sleek device used to remove it.The device then failed to deflate.The balloon was poked with the back end of an interventional wire in order to deflate the balloon.The type and brand of inflation device used is unknown and this device was not used successfully with other devices.The device was never in an acute bend.The maximum inflation pressure is unknown.There were no adverse consequences to the patient as a result of the failure with the device.There was no patient injury reported.The lot history records could not be reviewed as the lot number was unknown.The device was returned for evaluation.A two way valve adapter and a 6f cook introducer sheath both attached to the device were returned.The returned sample was in poor condition.No external or internal packing was returned.No sleeve was returned.The device arrived back with a 6f cook introducer sheath attached to the device.The catheter was inserted into the introducer sheath with the distal end of balloon exposed.The hub was printed as expected.There was evidence of a crack noted on the hub just at the inflation valve.A kink was noted on the outer just at the strain relief.There was evidence of 4 kinks on the inner, exit of strain relief, a 2nd major kink approx.835mm from the strain relief, 3rd major kink was noted approx.935mm from the strain relief and 4th major kink 10mm from proximal markerband.There was evidence of pale substance noted throughout the balloon.No visual defects were noted on the distal tip or markerbands.The total length of cook sheath returned with the device is approx.450.The tip of the introducer sheath appeared to be out of shape, it is not circular in shape.Two attempts to insert a 0.014" guidewire through the returned device proved unsuccessful due to a major kink noted on the inner just at the proximal markerband, so a decision was made to inflate the device without the guidewire.This also proved unsuccessful due to a crack noted in the hub.The hub was removed from the device and a final attempt was made to inflate the device, but this was also unsuccessful due to a leak was noted coming from distal tip.Due to the condition of the returned device the evaluation carried out was unable to confirm the reported failure mode.Based upon the available information a definitive root cause cannot be determined.It is unknown whether patient factors, handling or procedural techniques have contributed to the reported event.Based on analysis performed no additional action is required at this time.The ifu states: precautions: ¿ before removing catheter from sheath it is very important that the balloon is completely deflated.Recommended procedure and technique: (inflate and deflate the balloon manually by advancing and retracting the plunger of the inflation device.Maintain vacuum on the balloon between dilations by withdrawing the plunger of the inflation device.(7) after each inflation, assess run-off by angiography through the guiding catheter while the inflated balloon remains within or proximal to the stenosis.(8) to exchange catheters, maintain the guidewire¿s position and lossen the heamostatic valve.Pull out the dilation catheter until the guidewire entry point exits the heamostatic valve.Grasp the wire a short distance from the entry point and continue to withdraw the catheter.Continue to alternate grasping the guidewire and moving the catheter until the catheter tip clears the heamostatic valve.Insert the new catheter as previously described for the initial catheter.(10) simultaneously withdraw the dilation catheter and guidewire from the guiding catheter / sheath.Withdraw the guiding catheter / sheath from the vessel.Follow standard practice for the management of the guiding catheter /sheaths (removal should not be attempted before near normalisation of clotting).Deflation and withdraw ¿ deflate the balloon by drawing a vacuum with a 20ml or larger syringe.Note: the larger the syringe diameter, the greater the suction that is applied.For maximum deflation a 50cc syringe is recommended.¿ gently withdraw the catheter.As the balloon exits the vessel, use a smooth, gentle, steady, 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.

• Brand Name: SLEEK OTW
• 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 ; 539237111
• MDR Report Key: 6471153
• MDR Text Key: 72089512
• Report Number: 9616666-2017-00014
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K102035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN SLEEK OTW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention