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

Model Number	426-1510X
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 10/2022).Device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second 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 not returned.Three images were provided for review.Only one image showed a small section of the shaft of a device, however no other discernable observations could be made from the image, including the device details and the alleged balloon rupture.The result of the investigation is inconclusive for the reported balloon rupture issue.The definitive root cause for the reported balloon rupture issue could not be determined based upon the available information received from the field communications and images review.Labeling review: the instructions for use or the sleek otw product was reviewed and contains the following information relevant to the reported event: 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.Warnings: 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.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.Before removing catheter from sheath/guide catheter it is very important that the balloon is completely deflated.Directions for use: inspection and preparation: 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: insertion and inflation procedure: note: a 0.014¿ (0.356 mm) guidewire must be inserted in the sleek® otw catheter across the balloon during any inflation of the balloon.Make sure that the balloon sleeve has been removed from the 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 inflate the balloon or advance the catheter unless the guidewire is in place.

• Brand Name: SLEEK OTW PTA CATHETER
• Common Device Name: 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: 16119869
• Report Number: 9616666-2022-00273
• Device Sequence Number: 8489941
• Product Code: DQY
• UDI-Device Identifier: 00801741133541
• UDI-Public: (01)00801741133541
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K102035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 426-1510X
• Device Catalogue Number: 426-1510X
• Device Lot Number: CMDY0452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown