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

Model Number	426-1504X
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 catheter allegedly ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that the pta balloon catheter allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complaint lot history review was performed.The lot met all test release criteria.Nothing was found to indicate a manufacturing related cause for this event.This is the first reported complaint for this lot number and issue to date.There have been no other complaints reported of any type for this lot number.Investigation summary: the result of the investigation is confirmed for the balloon failure mode reported.Two ruptures each measuring half a millimeter in length were noted 1mm apart from each other approx.3mm from the distal markerband.The type and positioning of the ruptures may suggest that patient factors i.E.Severe calcification of the lesion may have been a contributory factor in the event.However patient factors were not provided after good faith attempts to source this information.Based upon the available information and sample evaluation a definitive root cause has not been determined.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.

• Brand Name: SLEEK OTW PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7364421
• Report Number: 9616666-2018-00032
• Device Sequence Number: 2365087
• Product Code: DQY
• UDI-Device Identifier: 00801741133527
• UDI-Public: (01)00801741133527
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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 Model Number: 426-1504X
• Device Catalogue Number: 426-1504X
• Device Lot Number: 50126642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1