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

Model Number	425-2022X
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the popliteal artery, the pta balloon allegedly failed to cross the lesion.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complaint history review was performed.This is the second complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.Two kinks were present on the inner lumen of the device, one at the proximal marker band and the second 18mm from the proximal marker band.The proximal marker band was also damaged / flattened.The patency was tested using an in-house.014¿ guidewire and the guidewire was unable to be advanced past the proximal marker band in the catheter.The result of the investigation is confirmed for the reported failure to advance issue.The root cause for the reported failure to advance issue could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: instructions for use for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: precautions: proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Directions for use: inspection and preparation if any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used.Procedure: insertion and inflation note: a 0.014¿ (0.356 mm) guidewire must be inserted in the sleek® catheter across the balloon during any inflation of the balloon.Attach a haemostatic valve to the appropriate guiding catheter/sheath, which has been previously inserted into the vasculature following standard product guidelines.Insert the guidewire (0.014¿ (0.356 mm) max) into the guiding catheter/sheath through the haemostatic valve.Under flouroscopy, position the guidewire across the lesion in accordance with accepted pta techniques.Make sure that the balloon sleeve has been removed from the catheter balloon.Back load the guidewire into the distal tip of the dilation catheter.Advance the dilation catheter in small steps to the tip of the guiding catheter/ sheath.Re-attach the torque device to the guidewire.Hold the guidewire stationary and advance the balloon catheter over the guidewire and across the stenosis.The radiopaque balloon marker and a low pressure (10 to 20 psi/69 to 138 kpa) balloon inflation should be used to confirm that the indentation caused by the stenosis is centrally located within the balloon segment before proceeding with the dilation.Never advance the balloon catheter against resistance, without first identifying the resistance and taking the necessary remedial action.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.Adequacy of the angioplasty treatment is assessed by angiography.The final evaluation is by angiography after the removal of the balloon catheters and guidewire.(expiry date: 07/2023).

• Brand Name: SLEEK RX PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16401975
• Report Number: 9616666-2023-00020
• Device Sequence Number: 14275180
• Product Code: LIT
• UDI-Device Identifier: 00801741132292
• UDI-Public: (01)00801741132292
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2023

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: 425-2022X
• Device Catalogue Number: 425-2022X
• Device Lot Number: CMEV0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown