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

Catalog Number 48522040

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 09/01/2021

Event Type  malfunction  

Event Description

It was reported that during a pta balloon placement procedure through right common femoral artery the device allegedly leaked.The procedure was completed with another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the savvy long pta dilatation catheter that are cleared in the us.The pro code and 510k number for the savvy long pta dilatation catheter is identified.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 balloon was inflated with water, however the balloon failed to maintain pressure.A longitudinal rupture in the balloon measuring 1mm and was located 27mm from distal tip.Therefore, the investigation is inconclusive for the reported leak issue but confirmed for material rupture of the balloon.The definitive root cause for the reported leak issue could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: the instruction for use for the bantam pta balloon catheter was reviewed and contains the following information relevant to the reported event: 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.Warnings: 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.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.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.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.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 exceed the rated burst pressure.(expiry date: 01/2024).

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12966933
• MDR Text Key: 288201981
• Report Number: 9616666-2021-00226
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391515540668
• UDI-Public: (01)05391515540668
• 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: 11/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48522040
• Device Lot Number: CMFP0161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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 Age: 75 YR
• Patient Sex: Female