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

Catalog Number 68202091

Device Problems Inflation Problem (1310); Material Rupture (1546)

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

Event Date 11/12/2023

Event Type  malfunction  

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: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2025).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 during an angioplasty procedure in carotid artery through right femoral artery approach, the pta balloon allegedly could not be filled.It was further reported that the balloon allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.

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.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.The device packaging was returned, the lot number on the packaging complied with the lot number logged on the gcs.Two images were also provided for review.The images were of the device packaging.The lot number on the packaging complied with the returned packaging.Therefore, the result of the investigation is inconclusive for the reported balloon inflation and rupture issues.The root cause for the reported balloon inflation and rupture issues could not be determined based upon the available information received from the field communications and images review.Labeling review: the instructions for use for this litepac rx device was reviewed and the following sections are applicable.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.Contraindications: ¿ none known.Warnings: ¿ reuse, resterilization, reprocessing and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Reusing this medical device bears the risk of cross-patient contamination as medical devices ¿ particularly those with long and small lumina, joints, and/or crevices between components ¿ are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time.The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.¿ visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.¿ 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 ¿ use the catheter prior to the ¿use by¿ date specified on the package.¿ this catheter is not recommended for pressure measurement or fluid injection.Precautions: ¿ dilation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.¿ 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.¿ careful attention must be paid to the maintenance of tight catheter connections to avoid the introduction of air into the system.¿ 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.Do not continue to use the balloon catheter if the shaft has been bent or kinked.¿ if the hypotube kinks prior to or during use the catheter should be discarded.No attempt should be made to straighten a kink in the hypotube.Storage: ¿ store in a cool, dark, dry place.Use the catheter prior to the ¿use by¿ date specified on the package.Directions for use: inspection and preparation: ¿ remove the protective sheath by first withdrawing the stylet and then slowly removing the sheath while holding the catheter as close to the balloon as possible.¿ if any resistance is felt, or if any stretching of the catheter is observed while removing the protective sheath, the product should not be used.¿ the catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.¿ prepare a mixture of contrast medium and normal saline as per normal procedure.(recommended 25% /75%) ¿ attach a stopcock and a 20 ml syringe half filled with the contrast solution to the balloon port.¿ point the syringe nozzle downward and aspirate until all air is removed from the balloon.¿ turn the stopcock off and maintain the vacuum in the balloon.¿ reinserting the balloon into the protective sheath may damage the balloon or catheter.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.¿ 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 fluoroscopy, position the guidewire across the lesion in accordance with accepted pta techniques.¿ make sure that the protective sheath has been removed from the balloon.Back load the guidewire into the distal tip of the balloon catheter.¿ advance the balloon 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.¿ 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.H10: d4 (expiration date: 06/2025), g3.H11: h6 (method, result, conclusion) h11: section a through f ¿ the information provided by bd represents all 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 during an angioplasty procedure in the carotid artery via the right femoral artery approach, the pta balloon allegedly could not be filled.It was further reported that the balloon allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.

• 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: 18298103
• MDR Text Key: 330150761
• Report Number: 9616666-2023-00244
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391509837552
• UDI-Public: (01)05391509837552
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68202091
• Device Lot Number: CMGU0052
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male