MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number 68202149

Device Problems Deflation Problem (1149); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the sleek rx pta catheter products that are cleared in the us.The pro code and 510 k number for the sleek rx pta catheter products are identified.(expiry date: 06/2024).

Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly failed to deflate.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 sleek rx pta catheter products that are cleared in the us.The pro code and 510 k number for the sleek rx 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 these reports.Investigation summary: the sample was returned for evaluation.The balloon was successfully inflated with water to 6atm , however during the deflation phase the balloon deflating slowly.The returned device exhibited a damaged inner.The inner was accordioned commencing at the proximal marker band for a section of 28mm within the balloon.The inner was also kinked at the proximal cone of the balloon.It is likely the damaged inner contributed to the deflation issue.It is unlikely that the damaged inner is manufacturing related as a 100% guidewire check is performed during catheter production.The result of the investigation is confirmed for the reported deflation issue.The root cause for the reported deflation issue could not be determined based upon the available information received from the field communications and device evaluation.Labeling review: the instructions for use for the litepac rx pta catheter was reviewed and contains the following information relevant to the reported event: 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.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.Reinserting the balloon into the protective sheath may damage the balloon or catheter.Insertion and inflation note: when the litepac catheter is in its¿ most distal position on the guidewire a guiding catheter/sheath which is long enough to cover the rapid exchange port must be used.Note: do not advance the guidewire, balloon 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 balloon catheter unless the guidewire is in place.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.Simultaneously withdraw the balloon catheter and guidewire from the guiding catheter/sheath.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 guiding catheter/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 guiding catheter/sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.Withdraw the guiding catheter/sheath from the vessel.Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous vascular procedures.H10: d4 (expiry date: 06/2024).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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly failed to deflate.There was no reported patient injury.

• Brand Name: LITEPAC RX 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: 13468613
• MDR Text Key: 286023257
• Report Number: 9616666-2022-00008
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391515540804
• UDI-Public: (01)05391515540804
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68202149
• Device Lot Number: CMFU0395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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