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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. SLEEK OTW PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 426-4010X
Device Problems Balloon (419); Wire (430); Break (1069); Burst Container or Vessel (1074); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2016
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 balloon ruptured. An outback device was used however the outback wire sheared off and the outback was unable to be retracted. The complaint device was used to dilate however the balloon burst. The wire tip was left inside the patient and therefore the patient will be required to e brought back into theatre later in the week. 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 balloon ruptured. An outback device was used however the outback wire sheared off and the outback was unable to be retracted. The complaint device was used to dilate however the balloon burst. The wire tip was left inside the patient. The patient was brought back into theatre later in the week and the procedure was completed successfully. The doctor is confident that the section of wire would not move and the patient has been booked for a repeat procedure. 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. No external or internal packing was returned. The hub was printed as expected and no visual defects were observed. There were three kinks noted on the outer. The first kink was noted approx. C. 65cm from the distal tip, the second kink was noted approx. C. 90cm from the distal tip and the third kink was noted approx. C. 110cm from distal tip. There was evidence that the inner was stretched and bunching was noticed in the inner. Total length of bunching was approx. C 58cm from the exit of the strain relief. It was noted that the distal tip of the device was damaged but in tack. No visual defects were observed on the balloon. An attempt was made to insert a 0. 014"guidewire into the hub of the device and also the distal tip. A blockage was detected close to the strain relief, and also at the distal tip of the device. Under closer inspection, it was observed that there was bunching noted on either end of the device. The inner was also stretched in the balloon. A total of six attempts were made to flush the device, however when this didn't work, a decision was made flush out the device with hot water. The device was attempted to be flushed a further 3 times with hot water. The device was immersed in hot water over night to flush out any dry contamination that had solidified within the device. An attempt to insert a 0. 014" guidewire through both the hub and distal tip was carried out but this was again unsuccessful. The balloon was inspected under magnification x 12 for a material rupture but none was detected. The device could not be inflated due to the condition of the device. The result of the investigation is inconclusive. A definite root cause cannot be determined. The visual and functional examination of the returned device could not confirm the material rupture. Also due to the condition of the device it could not be inflated. It was reported that an outback device was used with the complaint device in the procedure. It was also confirmed that the outback wire sheared off and the outback was unable to be retracted. This would indicate a difficult procedure making it likely that force was applied causing the bunching and tip damage to the complaint device it is likely that handling or procedural techniques have contributed to the reported event. Based on analysis performed no additional action is required at this time. (b)(4). An event has been raised in our quality system to address this issue. 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. After each inflation, assess run-off by angiography through the guiding catheter while the inflated balloon remains within or proximal to the stenosis. To exchange catheters, maintain the guidewire¿s position and loosen the haemostatic valve. Pull out the dilation catheter until the guidewire entry point exits the haemostatic 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 haemostatic valve. Insert the new catheter as previously described for the initial catheter. 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. (b)(4).

 
Event Description

It was reported that the balloon ruptured. An outback device was used however the outback wire sheared off and the outback was unable to be retracted. The complaint device was used to dilate however the balloon burst. The wire tip was left inside the patient. The patient was brought back into theatre later in the week and the procedure was completed successfully. The doctor is confident that the section of wire would not move and the patient has been booked for a repeat procedure. There was no patient injury reported.

 
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Brand NameSLEEK OTW
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 Key5889910
MDR Text Key53464508
Report Number9616666-2016-00017
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK102035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/30/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number426-4010X
Device LOT Number50126503
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received09/15/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/21/2015
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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