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

Catalog Number	426-3022X
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during a peripheral vascular angioplasty procedure involving the anterior tibial artery of the lower limb using a sleek otw pta catheter.Prior to vessel insertion, it was observed that the protective plastic was adhered to the balloon, causing detachment from the device shaft and rendering the catheter unusable.The procedure was completed using another device.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.D2b (dqy; lit).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.
Additional Manufacturer Narrative
H11: manufacturing review: this is the third complaint reported for this product / lot number combination.A dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sleek otw device was not returned for evaluation.However, three photos were provided for review.Photo 1.A catheter as two sections was shown placed on green material.The first section comprised of the hub and shaft, but due to the poor resolution the hub print was not visible.The second section consisted of the distal end.The balloon sleeve was in place; the shipping mandrel was shown exciting the inner lumen which was exposed past the proximal end of the balloon.Photo 2.Two hcps were shown, medical instruments were shown in the background.The alleged device was not in view in the photo.Photo 3.A catheter as two sections were shown placed on white material.The first section comprised of the hub and shaft, but due to the poor resolution the hub print was blurred and could not be determined.The second section consisted of the distal end.The balloon sleeve was partially removed from the balloon, the shipping mandrel was shown exciting the inner lumen which was exposed past the proximal end of the balloon.The result of the investigation is confirmed for the device break and inconclusive for the balloon sleeve issue.The root cause for the reported device break and balloon sleeve issues could not be determined based upon available information and photos review.Labelling review: the instruction for use for this sleek otw device was reviewed and the following sections are applicable.Balloon characteristics: please check the package label for the rated burst pressure (rbp).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.Compliance charts are provided with each product.Please note that balloon diameters may vary within manufacturing tolerances.All inflations should be viewed under fluoroscopy.The sleek otw balloons reach their nominal diameter at 6 atm (608 kpa).Indications: the sleek otw catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.These catheters are not designed to be used in the coronary arteries.Warnings: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not reuse, reprocess or resterilize.This product is designed and intended for single use.It is not designed to undergo reprocessing and re-sterilization after initial use.Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.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.Use the catheter prior to the ¿use by¿ date specified on the package.Do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action.Precautions: carefully inspect the catheter prior to use to verify that the 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.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.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 balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve 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 balloon sleeve, 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.Purge the catheter through lumen thoroughly.Reinserting the balloon into the balloon sleeve may damage the balloon or catheter.Procedure: insertion and inflation procedure: note: a 0.014 (0.356 mm) guidewire must be inserted in the sleek otw catheter across the balloon during any inflation of the balloon.Make sure that the balloon sleeve has been removed from the catheter balloon.Enter the vessel percutaneously using the standard seldinger technique over the appropriate guidewire for the size catheter being used.Advance the catheter across the lesion with fluoroscopic guidance using accepted percutaneous transluminal angioplasty technique and inflate the balloon to the appropriate pressure.Note: do not inflate the balloon or advance the catheter unless the guidewire is in place.D2b (dqy; lit), g2, g3, h6 (component, method, result, conclusion) 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 or Problem Description
On (b)(6) 2025, during a peripheral vascular angioplasty procedure involving the anterior tibial artery of the lower limb using a sleek otw pta catheter.Prior to vessel insertion, it was observed that the protective plastic was adhered to the balloon, causing detachment from the device shaft and rendering the catheter unusable.The procedure was completed using another device.There was no reported patient contact.

• Brand Name: SLEEK OTW 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: 22673183
• Report Number: 9616666-2025-00186
• Device Sequence Number: 12645624
• Product Code: LIT
• UDI-Device Identifier: 00801741133787
• UDI-Public: (01)00801741133787(11)230216(17)260131(10)CMHP0219
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K102035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 426-3022X
• Device Lot Number: CMHP0219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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 Age: 80 YR
• Patient Sex: Unknown