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

Catalog Number 426-3022X

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Difficult to Open or Remove Packaging Material (2922); Material Deformation (2976)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 01/2026).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 preparation of an angioplasty procedure, the balloon sleeve was allegedly difficult to remove.It was further reported that the balloon allegedly wouldn¿t deflate.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during preparation of an angioplasty procedure, the balloon sleeve was allegedly difficult to be removed.It was further reported that upon deflation in the patient, the balloon wouldn¿t deflate.Furthermore, a buddy wire was used beside the balloon and with minimal inflation, the balloon slid back up to the sheath in the right femoral artery.Reportedly, with the balloon in the right femoral artery, a cut down was done and the remaining balloon portions were removed.The procedure was completed using another device.The current status of the patient is unknown.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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 device was returned for evaluation.The device was extensively damaged and was returned in five separate sections.The hub and strain relief section was broken on the outer shaft just adjacent to the strain relief.The shaft outer was also returned separate to the inner lumen and balloon sections.The inner lumen was returned in two sections and was stretched and bunched along its lengths.The balloon was reversed back over the distal tip (inside out) and still attached to distal tip section.A break was noted at the balloon proximal taper point.The balloon had evidence of previous inflation.Biological residue was present on balloon.Two longitudinal ruptures adjacent to each other were also confirmed.The rupture were approx 54mm in length and commenced 22mm from the distal end.Therefore, the result of the investigation is inconclusive for the reported balloon sleeve removal difficulty, balloon deflation and device difficulty to remove issues.The root cause for the reported balloon sleeve removal difficulty, balloon deflation and device difficulty to remove issues could not be determined based upon the available information received from the field communications and device evaluation.Labeling 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: ¿ 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.¿ 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 introducer sheath.¿ 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 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.¿ if resistance is felt upon removal, then the balloon, guidewire and the sheath/guide catheter 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 sheath/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction.¿ before removing catheter from sheath/guide catheter it is very important that the balloon is completely deflated.¿ 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: deflation and withdrawal ¿ deflate the balloon by drawing a vacuum with a 20 ml or larger syringe.Note: the larger the syringe diameter, the greater the suction that is applied.For maximum deflation a 50 ml syringe is recommended.¿ gently withdraw the catheter.As the balloon exits the vessel, use a smooth, gentle, steady, counterclockwise motion.If resistance is felt upon removal then the balloon and the sheath should be removed together as a unit under fluoroscopic guidance, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.H10: d4 (expiry date: 01/2026), g3, h6 (device) h11: b5, h1, h6 (patient, method, result) 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.H3 other text : see h10.

• Brand Name: SLEEK OTW 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: 18316795
• MDR Text Key: 330356318
• Report Number: 9616666-2023-00250
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 426-3022X
• Device Lot Number: CMHP0219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male