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

Catalog Number 48522025

Device Problems Break (1069); Inflation Problem (1310); Stretched (1601); Material Deformation (2976)

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

Event Date 11/21/2023

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 510k 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 catheter was returned for evaluation.A break at the taper point of the balloon at the proximal bond was confirmed.The inner was also stretched, the distance of the break between the balloon and the outer was 32mm.Two kinks were also present in the area of the break.5 kinks were present on the inner in total.There was no evidence of previous balloon inflation, the pleats and folds were intact.The balloon sleeve was not returned.One image was also provided for review.The image showed a break in the vicinity of the proximal end of the balloon and the catheter outer shaft.The inner was also stretched.The damage to the device - the break, the stretched and kinked inner suggest that user handling (excessive force) was responsible for the damage, likely occurring during the removal of the sleeve during device preparation.Therefore, the result of the investigation is confirmed for the reported inflation issue.The root cause for the reported inflation issue could not be determined based upon the available information received from the field communications, device evaluation and image review.Labeling review: the instructions for use for this bantam otw device was reviewed and the following sections are applicable.Balloon characteristics individual compliance charts are provided on the package label of each product.Please note that balloon diameters may vary within manufacturing tolerances.All inflations should be viewed under fluoroscopy.The bantam¿ 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 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.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.Use a 20 ml or larger syringe for inflation.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.This catheter is not recommended for pressure measurement or fluid injection.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.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.Make sure that the protective sheath has been removed from the dilation catheter balloon.H10: d4 (expiration date: 09/2025) 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 prior to an angioplasty procedure in lower limb arterial, the pta balloon allegedly could not inflate.The procedure was completed using another device.There was no patient contact.

• 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: 18582560
• MDR Text Key: 334731446
• Report Number: 9616666-2024-00008
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391515540637
• UDI-Public: (01)05391515540637
• 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
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48522025
• Device Lot Number: CMGX0454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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