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

Catalog Number 48522040

Device Problems Inflation Problem (1310); Peeled/Delaminated (1454); Material Twisted/Bent (2981)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation with the guidewire was not returned.The result of the investigation is inconclusive for the reported inflation issue.The balloon of the returned device was inflated successfully with water and maintained pressure at 6atm.Prior to the inflation attempt a twist in the balloon was confirmed 85mm from the distal tip.When inflated there was some evidence of minor creases at the twist location.When the balloon was deflated the twist was not apparent.The patency of the bantam device was performed using an inhouse 0.018¿ guidewire but was not successful.The guidewire encountered a blockage between the proximal marker band and the balloon cone.The blockage was due to inner delamination in this area.The definitive root cause for the reported inflation issue could not be determined based upon the available information.Labeling review: the instructions 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: use a 20 ml or larger syringe for inflation.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: 06/2022).

Event Description

It was reported that during an angioplasty procedure, the device allegedly had inflation issue.There was another device used to complete the procedure.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12679058
• MDR Text Key: 278164073
• Report Number: 9616666-2021-00170
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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: CMDU0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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: 40 YR
• Patient Weight: 60