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

Catalog Number 48512035

Device Problems Break (1069); Difficult to Insert (1316); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 11/28/2023

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 savvy long otw pta catheter products that are cleared in the us.The pro code and 510 k number for the savvy long otw pta catheter 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 physical sample was returned for evaluation.The device was returned as two sections, the first section measures 80mm, second section measures 1240mm.The inner was heavily bunched within the hub guidewire lumen.The catheter break and bunched inner are likely user related.Excessive force may have been applied by the user resulting in the damage.Therefore, the result of the investigation is confirmed for difficult to insert and device incompatibility issues.The root cause for the reported difficult to insert and device incompatibility 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 this bantam otw device was reviewed and the following sections are applicable.Indications: the bantam¿ 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.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 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 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 as a unit and withdrawing both together, using a gently twisting motion combined with traction.Before removing catheter from sheath it is very important that the balloon is completely deflated and all contrast media completely evacuated.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.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.Purge the catheter guidewire lumen thoroughly.Reinserting the balloon into the protective sheath may damage the balloon or catheter.Insertion and inflation note: do not advance the guidewire, balloon dilation 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 catheter unless the guidewire is in place.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.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, guidewire 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: 03/2025) 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 the superficial femoral artery through the femoral artery approach, resistance was allegedly felt when the tail of the balloon was passed through the guidewire.It was further reported that when retracted, the tail of the balloon was allegedly found to be stuck with the guidewire and could not be moved.Furthermore, traces of the guidewire epidermis located outside the patient's body was allegedly found to be peeled off.Reportedly, the tail of the balloon and the guidewire together was broken and withdrawn from the body.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 savvy long otw pta catheter products that are cleared in the us.The pro code and 510 k number for the savvy long otw pta catheter 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 physical sample was returned for evaluation.The device was returned as two sections, the first section measures 80mm, second section measures 1240mm.The inner was heavily bunched within the hub guidewire lumen.The catheter break and bunched inner are likely user related.Excessive force may have been applied by the user resulting in the damage.Therefore, the result of the investigation is confirmed for difficult to insert, device incompatibility, material deformation and break issues.The root cause for the reported difficult to insert, device incompatibility, material deformation and break 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 this bantam otw device was reviewed and the following sections are applicable.Indications: the bantam¿ 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.¿ 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 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 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 as a unit and withdrawing both together, using a gently twisting motion combined with traction.¿ before removing catheter from sheath it is very important that the balloon is completely deflated and all contrast media completely evacuated.¿ 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.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.¿ purge the catheter guidewire lumen thoroughly.¿ reinserting the balloon into the protective sheath may damage the balloon or catheter.Insertion and inflation: note: do not advance the guidewire, balloon dilation 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 catheter unless the guidewire is in place.¿ 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.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, guidewire 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: 03/2025).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 the superficial femoral artery through the femoral artery approach, resistance was allegedly felt when the tail of the balloon was passed through the guidewire.It was further reported that when retracted, the tail of the balloon was allegedly found to be stuck with the guidewire and could not be moved.Furthermore, traces of the guidewire epidermis located outside the patient's body was allegedly found to be peeled off.Reportedly, the tail of the balloon and the guidewire together was broken and withdrawn from the body.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: BANTAM 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: 18657087
• MDR Text Key: 334840435
• Report Number: 9616666-2024-00016
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391509839570
• UDI-Public: (01)05391509839570
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48512035
• Device Lot Number: CMGR0452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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 Sex: Male