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

Model Number	426-2022X
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.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.
Event or Problem Description
It was reported that the pta balloon allegedly ruptured during the second inflation.Reportedly, the device was removed from the patient without incident.There was no reported patient injury.
Additional Manufacturer Narrative
The lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.The result of the investigation was inconclusive.Due to the condition of the returned device the evaluation was unable to confirm the balloon rupture failure mode.The device did inflate on its first inflation and subsequently ruptured on the second inflation.Based upon the evaluation and available information a definitive root cause has not been determined.It is unknown if patient factors, handling or procedural techniques may have contributed to the reported event.Labeling review: the ifu (in122 rev04) was reviewed and contains the following information relevant to the reported event: 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.
Event or Problem Description
It was reported that the pta balloon allegedly ruptured during the second inflation.Reportedly, the device was removed from the patient without incident.There was no reported patient injury.

• Brand Name: SLEEK OTW PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7374109
• Report Number: 9616666-2018-00034
• Device Sequence Number: 1373813
• Product Code: LIT
• UDI-Device Identifier: 00801741133626
• UDI-Public: (01)00801741133626
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K102035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 426-2022X
• Device Catalogue Number: 426-2022X
• Device Lot Number: 50123991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1