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

Model Number	426-1508X
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
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 under way.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 procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the production history for the device was reviewed and no anomalies were identified.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.Investigation summary: the evaluation of the returned device confirmed the failure mode reported, material rupture.A full circumferential rupture was noted at the proximal end of the balloon.Based upon the 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 events.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 loosen the hemostatic valve.Pull out the dilation catheter until the guidewire entry point exits the hemostatic 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 hemostatic 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.Expiry date: dec / 2019.
Event or Problem Description
It was reported that the pta balloon allegedly ruptured during the procedure.There was no reported patient injury.

• 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: 7553640
• Report Number: 9616666-2018-00068
• Device Sequence Number: 1986053
• Product Code: DQY
• UDI-Device Identifier: 00801741133534
• UDI-Public: (01)00801741133534
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 426-1508X
• Device Catalogue Number: 426-1508X
• Device Lot Number: CMBN0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1