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

Catalog Number 48515025

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: the device was returned for evaluation.The result of the investigation is confirmed for the reported difficult to advance and device incompatibility issue.A video was also provided for review.The definitive root cause for the reported difficult to advance and device incompatibility 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: 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.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: 10/2023).

Event Description

It was reported that during preparation of a procedure, the guidewire allegedly could not pass.The procedure was completed using another device.There was no patient contact.

Event Description

It was reported that during preparation of a procedure, the guidewire allegedly could not pass.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the savvy long pta dilatation catheter products that are cleared in the us.The pro code and 510 k number for the savvy long pta dilatation 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 lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: the device was returned for evaluation.A patency test using an inhouse 0.018¿ guidewire was performed on the bantam device, however this was unsuccessful.On guidewire removal, a substance likely solidified contrast media was present on the guidewire tip.The inner lumen was then flushed twice with warm water, the patency test was repeated using the inhouse 0.018¿ guidewire and was successful.A video was also provided for review.The hcp is seen inserting a guidewire of unknown size into the guidewire lumen of the device.It is apparent that hcp is having difficulty advancing the guidewire through the catheter and is then seen removing the guidewire from the hub at the end of the video.The result of the investigation is confirmed for the reported difficult to advance, device contamination and device incompatibility issue.A definitive root cause 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: 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.¿ 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.H10: d4 (expiry date: 10/2023), g3.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.

• 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
• MDR Report Key: 12679204
• MDR Text Key: 277899674
• Report Number: 9616666-2021-00173
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391515540491
• UDI-Public: (01)05391515540491
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2021

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: 48515025
• Device Lot Number: CMEY0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Date Manufacturer Received: 10/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 60