MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER; PTA BALLOON DILATATION CATHETERS

Model Number 436-3015X

Device Problems Material Rupture (1546); Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 02/16/2022

Event Type  malfunction  

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.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that during an angioplasty procedure in the lower extremity arteriosclerosis via a moderately calcified lesion to treat the femoral popliteal segment and the superficial segment of the femur, the pta balloon was allegedly difficult to reach the lesion and it was further reported that the balloon ruptured at 12 atm.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the lower extremity arteriosclerosis via a moderately calcified lesion to treat the femoral popliteal segment and the superficial segment of the femur, the pta balloon was allegedly difficult to reach the lesion and it was further reported that the balloon ruptured at 12 atm.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is first complaint reported for this product / lot number combination, therefore a device history record review is not required.Investigation summary: the device was returned for evaluation.The result of the investigation is inconclusive for the reported balloon rupture and difficult to advance issues.The returned device confirmed a 10mm tear section in the balloon commencing 75mm from the proximal marker and continuing towards the distal end.The outer exhibited damaged 7mm from the proximal cone of the balloon.Possible contributing factors for the balloon tear and damaged outer include the reported moderately calcified lesion and also user handling or procedural techniques.The patency of the savvy long device was performed using an in house 0.018" guidewire without any issue.The root cause for the reported balloon rupture and difficult to advance issues 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 savvy long 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.Compliance charts are provided with each product.Please note that balloon diameters may vary within manufacturing tolerances.All inflations should be viewed under fluoroscopy.The savvy® long balloons reach their nominal diameter at 6 atm (608 kpa).The 2.0 mm ¿ 6.0 mm balloons contain a trifold.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 only an endoflator or 20 ml syringe for inflation.¿ use the catheter prior to the ¿use by¿ date specified on the package.¿ 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.¿ if resistance is felt upon removal, then the balloon, guidewire and the sheath/ guide catheter 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/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction.¿ 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.Description: a 0.018" guidewire is recommended for use with the savvy long catheters.Warnings: do not advance the guidewire, balloon dilatation catheter, or any component if resistance is met, without first determining the cause and taking remedial action.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.Directions for use: remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible.Id an resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, 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.Procedure: insertion and inflation procedure: note: a 0.018¿ (0.457 mm) guidewire must be inserted in the savvy® long 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.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: SAVVY LONG OTW PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETERS
• 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: 13730156
• MDR Text Key: 287016390
• Report Number: 9616666-2022-00046
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132940
• UDI-Public: (01)00801741132940
• 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,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 436-3015X
• Device Catalogue Number: 436-3015X
• Device Lot Number: CMDT0238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Weight: 60 KG