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

Catalog Number	426-1508X
Medical Device Problem Codes	Break (1069); Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H11: d2b (lit; dqy).H11: section a through f: the information provide 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 or Problem Description
On (b)(6) 2025, a patient underwent a procedure using the sleek otw pta catheter.Prior to the procedure, the balloon was removed from the tray and found to be broken into 3 sections.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: a complaint history review was performed.This is the first 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 device was partially returned in two sections.Section 1 measured 1420mm in length, comprising of the hub, outer shaft and the partial inner lumen.A break was present at the proximal balloon taper point.A section of the inner lumen measuring 165mm in length was missing from within the shaft.Section 2 measured 380mm, comprising of the inner lumen which was damaged - kinked and stretched.The catheter device distal section consisting of the balloon, sleeve, shipping mandrel and distal tip was not returned.However, the communications stated that the issue occurred during device preparation and based on the condition of the partially returned device it is likely that user excessive force was responsible for the damage.The definitive root cause for the reported device break issue could not be determined based upon the available information received from the field communication and device evaluation.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%).D2b (lit; dqy), d4 (unique identifier udi) #), g3, h4, h6 (device, component, method, result, conclusion).Section a through f ¿ the information provide 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 or Problem Description
On (b)(6), 2025, a patient underwent a procedure using the sleek otw pta catheter.It was reported that prior to the procedure, the balloon was removed from the tray and found to be broken into 3 sections.There was no 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: 22210069
• Report Number: 9616666-2025-00145
• Device Sequence Number: 8262384
• Product Code: DQY
• UDI-Device Identifier: 00801741133534
• UDI-Public: (01)00801741133534(11)220803(17)250731(10)CMGV0012
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 07/31/2025
• Device Catalogue Number: 426-1508X
• Device Lot Number: CMGV0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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