MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400804S

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

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

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82235433 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the powerflex pro 8mm 4cm 80 burst while inflating the draining vessel of a shunt, and half of the balloon remained in the patient during withdrawal of the device.The balloon had torn right through.The part was removed from the patient.An extra intervention had to be done to remove the part of the balloon.There was no reported injury to the patient.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: a2, a3, a4, b5, g3, h1, h2, h3 and h6.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the powerflex pro 8mm 4cm 80 burst under rbp while inflating the draining vessel of a shunt in the arm.Half of the balloon remained in the patient during withdrawal of the device.The balloon had torn right through.The part was removed from the patient using a snare and suction.An extra intervention had to be done to remove the part of the balloon.The case was completed due to the stenosis disappearing, no balloon was used.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks and any other damages noted to the device prior to inserting into the patient.The device was prepper per the ifu.The catheter was prepped normally and was able to maintain negative pressure.A 6f non-cordis sheath was used along with a.035 180cm non-cordis guidewire.The lesion did not have any calcification and the vessel did not have any tortuosity.The lesion was noted to have a 90-95% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was difficulty noted while advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The balloon separated during removal from the patient.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the powerflex pro 8mm 4cm 80 burst under rbp while inflating the draining vessel of a shunt in the arm.Half of the balloon remained in the patient during withdrawal of the device.The balloon had torn right through.The part was removed from the patient using a snare and suction.An extra intervention had to be done to remove the part of the balloon.The case was completed due to the stenosis disappearing, no balloon was used.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks and any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The catheter was prepped normally and was able to maintain negative pressure.A 6f non-cordis sheath was used along with a.035 180cm non-cordis guidewire.The lesion did not have any calcification and the vessel did not have any tortuosity.The lesion was noted to have a 90-95% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or while inserting the balloon through the guide catheter.There was difficulty noted while advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The balloon separated during removal from the patient.Procedural images were requested; however, images were not obtained after multiple attempts.The product was not returned for analysis after multiple attempts were made.A product history record (phr) review of lot 82235433 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ and ¿balloon- separated - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.The procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and are therefore, often resistant to balloon expansion increasing the likelihood of damage to the balloon.Angioplasty procedures involve the introduction of a sheath, stiff guidewires, balloons, catheters, and stents.During angioplasty, these devices pose potential risks factors, including balloon rupture and separation due to the scarred and fibrous nature of the shunt, thus damaging balloon material upon inflation.It is likely vessel characteristics, procedural factors and handling of the device contributed to the events reported.However, without return of the device for analysis it is difficult to draw a clinical conclusion between the device and the reported events.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the powerflex pro 8mm 4cm 80 burst under rbp while inflating the draining vessel of a shunt in the arm.Half of the balloon remained in the patient during withdrawal of the device.The balloon had torn right through.The part was removed from the patient using a snare and suction.An extra intervention had to be done to remove the part of the balloon.The case was completed due to the stenosis disappearing, no balloon was used.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks and any other damages noted to the device prior to inserting into the patient.The device was prepper per the ifu.The catheter was prepped normally and was able to maintain negative pressure.A 6f non-cordis sheath was used along with a.035 180cm non-cordis guidewire.The lesion did not have any calcification and the vessel did not have any tortuosity.The lesion was noted to have a 90-95% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was difficulty noted while advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The balloon separated during removal from the patient.The device will not be returned for evaluation as multiple attempts were made.Procedural images were requested, however, images were not obtained after multiple attempts.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the powerflex pro 8mm 4cm 80 burst under rbp while inflating the draining vessel of a shunt in the arm.Half of the balloon remained in the patient during withdrawal of the device.The balloon had torn right through.The part was removed from the patient using a snare and suction.An extra intervention had to be done to remove the part of the balloon.The case was completed due to the stenosis disappearing, no balloon was used.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks and any other damages noted to the device prior to inserting into the patient.The device was prepper per the ifu.The catheter was prepped normally and was able to maintain negative pressure.A 6f non-cordis sheath was used along with a.035 180cm non-cordis guidewire.The lesion did not have any calcification and the vessel did not have any tortuosity.The lesion was noted to have a 90-95% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was difficulty noted while advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The balloon separated during removal from the patient.The device was returned for evaluation.Procedural images were requested, however, images were not obtained after multiple attempts.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6 as reported, the powerflex pro 8mm 4cm 80 burst under rbp while inflating the draining vessel of a shunt in the arm.Half of the balloon remained in the patient during withdrawal of the device.The balloon had torn right through.The part was removed from the patient using a snare and suction.An extra intervention had to be done to remove the part of the balloon.The case was completed due to the stenosis disappearing, no balloon was used.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks and any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The catheter was prepped normally and was able to maintain negative pressure.A 6f non-cordis sheath was used along with a.035 180cm non-cordis guidewire.The lesion did not have any calcification and the vessel did not have any tortuosity.The lesion was noted to have a 90-95% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or while inserting the balloon through the guide catheter.There was difficulty noted while advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The balloon separated during removal from the patient.Procedural images were requested; however, images were not obtained after multiple attempts.The product was returned for analysis.A non-sterile powerflex pro 8mm x 4cm 80 percutaneous transluminal angioplasty (pta) balloon catheter involved in the complaint was received for analysis inside a plastic bag.Per visual analysis, a separation and a ruptured condition were observed on the inner body of the powerflex pro catheter unit at the balloon area.Also, the balloon was found separated/ruptured.No other physical characteristics could be seen.Per microscopic analysis, sem analysis was performed to the received separated inner body as well as on the separated/ruptured balloon.Results showed that the balloon of the powerflex pro 8mm 4cm 80 device presented evidence of a scratch marks and striations.In addition, the inner body presented evidence of plastic deformations and scratch marks.These types of damage are commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon could have led to the damaged condition found on the received device.It seems the material near the damage was ruptured by a sharp object from the outside of the device.In addition, the plastic deformations and the striations found on the material are commonly associated with fractures/separations caused by material tensile overload.Therefore, it is assumed that the component material was induced to a tensile force that exceeded the material yield strength prior to the separation.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82235433 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ and ¿balloon- separated - in-patient¿ were confirmed via device analysis and by visual analysis as received.The exact cause could not be determined.The procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and are therefore, often resistant to balloon expansion increasing the likelihood of damage to the balloon.Angioplasty procedures involve the introduction of a sheath, stiff guidewires, balloons, catheters, and stents.During angioplasty, these devices pose potential risks factors, including balloon rupture and separation due to the scarred and fibrous nature of the shunt, thus damaging balloon material upon inflation.It is likely vessel characteristics, procedural factors and handling of the device contributed to the events reported as evidenced by device analysis.Scratch marks were noted to the balloon material and plastic deformations along with fatigue striations were noted prior to the separation of the inner lumen of the device.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Carefully advance the catheter to the selected stenosis.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.When an acceptable position has been obtained, inflate the balloon to achieve the desired dilatation.Caution: do not exceed the rated burst pressure.Higher pressures may damage the balloon or catheter or overdistend the selected artery.Warning: inflation at a high rate may damage the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the powerflex pro 8mm 4cm 80 burst under rbp while inflating the draining vessel of a shunt in the arm.Half of the balloon remained in the patient during withdrawal of the device.The balloon had torn right through.The part was removed from the patient using a snare and suction.An extra intervention had to be done to remove the part of the balloon.The case was completed due to the stenosis disappearing, no balloon was used.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks and any other damages noted to the device prior to inserting into the patient.The device was prepper per the ifu.The catheter was prepped normally and was able to maintain negative pressure.A 6f non-cordis sheath was used along with a.035 180cm non-cordis guidewire.The lesion did not have any calcification and the vessel did not have any tortuosity.The lesion was noted to have a 90-95% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was difficulty noted while advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The balloon separated during removal from the patient.The device was returned for evaluation.Procedural images were requested, however, images were not obtained after multiple attempts.

• Brand Name: POWERFLEXPRO 8MM4CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14135368
• MDR Text Key: 289436203
• Report Number: 9616099-2022-05553
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059814
• UDI-Public: (01)20705032059814(17)241031(10)82235433
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4400804S
• Device Catalogue Number: 4400804S
• Device Lot Number: 82235433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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
• Treatment: UNK.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG