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

Catalog Number 68202087

Device Problems Deflation Problem (1149); Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

It was reported that during angioplasty procedure, the balloon was found unable to be inflated or deflated properly, interrupting the operation and affecting operation progress.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the sleek rx catheters products that are cleared in the us.The pro code and 510 k number for the sleek rx catheters products are identified in d2 and g4.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2025).Device pending return.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the sleek rx catheters products that are cleared in the us.The pro code and 510 k number for the sleek rx catheters products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first 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.The device was returned clean and packed within its hoop.The shipping mandrel was in place in the device, the sleeve was present on the balloon, both were then removed during the evaluation.There was no evidence of previous balloon inflation, the pleats and folds were intact.An attempt was made to inflate the balloon with water, however while the the balloon did inflate it did not maintain pressure and deflated.A leak confirmed at the re-port.The result of the investigation is confirmed for the reported inflation issue and unconfirmed for the deflation issue.The root cause for the reported inflation and deflation issues could not be determined based upon the available information received from the field communications and device evaluation.Labeling review: the instructions for use for the litepac rx pta catheter was reviewed and contains the following information relevant to the reported event: description: a 0.014¿ (0.356 mm) guidewire is recommended for use with the litepac rapid exchange pta balloon catheter.Description: balloon characteristics: individual compliance charts are provided on the package label of each product.The semi-compliant balloon has a 8% ± 4% growth in diameter from nominal to rated burst pressure.All inflations should be viewed under fluoroscopy.The litepac¿ balloons reach their nominal diameter at 6 atm (608 kpa).Please check the package label for the rated burst pressure.It is important that the balloon not be inflated beyond the rated burst pressure.Pressures in excess of rated burst pressure may cause the balloon to burst.Indications: the litepac pta balloon catheters are intended for balloon dilatation of renal, iliac and femoral arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.These catheters are not designed to be used in the coronary arteries.Warnings: do not exceed the rated burst pressure.A syringe with pressure gauge is recommended to monitor pressure.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the guiding catheter/introducer sheath.Use only an endoflator or a 20 ml or larger syringe for inflation do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action.This catheter is not recommended for pressure measurement or fluid injection.Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.If resistance is felt upon removal, then the balloon, guidewire and the guiding catheter/sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and guiding catheter/ sheath as a unit and withdrawing both together, using a gently twisting motion combined with traction.Before removing catheter from the guiding catheter/sheath it is very important that the balloon is completely deflated and all contrast media completely evacuated.Directions for use: insertion and inflation: note: when the litepac¿ catheter is in its¿ most distal position on the guidewire a guiding catheter/sheath which is long enough to cover the rapid exchange port must be used.Note: do not advance the guidewire, balloon catheter, or any component if resistance is met, without first determining the cause and taking remedial action.Note: do not inflate the balloon or advance the balloon catheter unless the guidewire is in place.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.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.Note: do not exceed the rated burst pressure.After each inflation, assess run-off by angiography through the guiding catheter while the inflated balloon remains within or proximal to the stenosis.H10: d4 (expiry date: 02/2025).H11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that prior to an angioplasty procedure, the balloon was found unable to be inflated or deflated properly, interrupting the operation and affecting operation progress.The procedure was completed using another device.There was no patient contact.

• Brand Name: LITEPAC RX PTA CATHETER
• Type of Device: 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: 16478314
• MDR Text Key: 310615054
• Report Number: 9616666-2023-00026
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391509837514
• UDI-Public: (01)05391509837514
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68202087
• Device Lot Number: CMGQ0413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female