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

Model Number 436-4015L

Device Problems Material Rupture (1546); Material Deformation (2976)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure in the iliac artery, the balloon allegedly ruptured at 15 atm.The balloon was removed off the patient.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be 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 iliac artery, the balloon allegedly ruptured at 15 atm.The balloon was removed off the patient.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.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.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot.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 sample was returned for evaluation.During the investigation the balloon was inflated with water but failed to maintain pressure.This was due to a balloon pinhole rupture located 20mm from the distal marker band.The result of the investigation is confirmed for the reported balloon rupture issue.The root cause for the reported balloon rupture issue could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: the instructions 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.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.Procedure: inspection and preparation.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.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.If any 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.Reinserting the balloon into the balloon sleeve may damage the balloon or catheter.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.Do not exceed the following rated burst pressures: 15 atm/1520 kpa (2 - 4 mm balloon); 13 atm/1317 kpa (5 mm balloon); 12 atm/1216 kpa (6 mm balloon).H10: d4 (expiry date: 05/2022), g3, h2, h6 (device, method).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.

Event Description

It was reported that during an angioplasty procedure in the iliac artery, the balloon allegedly ruptured at 15 atm.The balloon was removed off the patient.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the iliac artery, the balloon allegedly ruptured at 15 atm.The balloon was removed off the patient.There was no reported patient injury.

Manufacturer Narrative

H10: the initial mdr was inadvertently submitted with a g3 date of 15-11-2021.The correct g3 date is 12-11-2021.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot.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 sample was returned for evaluation.During the investigation the balloon was inflated with water but failed to maintain pressure.This was due to a balloon pinhole rupture located 20mm from the distal marker band.Therefore, the investigation is confirmed for the reported issues.The root cause for the reported balloon rupture issue 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.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.Procedure: inspection and preparation.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.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.If any 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.Reinserting the balloon into the balloon sleeve may damage the balloon or catheter.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.Do not exceed the following rated burst pressures: 15 atm/1520 kpa (2 - 4 mm balloon).13 atm/1317 kpa (5 mm balloon).12 atm/1216 kpa (6 mm balloon).H10: d4 (expiry date: 05/2022), g3.H11: section a through f ¿ the information provide by bd represents all 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.

• Brand Name: SAVVY LONG 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: 12965971
• MDR Text Key: 284807665
• Report Number: 9616666-2021-00225
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741133169
• UDI-Public: (01)00801741133169
• 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,Followup,Followup
• Report Date: 02/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 436-4015L
• Device Catalogue Number: 436-4015L
• Device Lot Number: CMDT0264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/17/2021; 01/31/2022; 02/07/2022
• Supplement Dates FDA Received: 01/12/2022; 02/03/2022; 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2019
• 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