MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM15CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400615X

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.

Event Description

As reported, radiographic agent was found to be extravasated during dilation with the powerflex pro 6mmx15cm.There was no reported injury to the patient.The patient has a long segment stenosis in the left superficial femoral artery (sfa).The unknown 5f sheath was punctured through the right femoral artery.After the angiography was done, that sheath was replaced with a 6f 40cm non-cordis sheath.A unknown guide wire passed through the lesion.The non-cordis balloon catheter was than expanded and the non-cordis stent and smart stent were placed.Stenosis remained after angiography was done.The powerflex pro 6x15 balloon was expanded posteriorly.This is when the extravasation was noted.A new powerflex pro 6x22 balloon was used and the flow rate of contrast was normal.The product stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion did not have any calcification.The vessel was noted to have a little tortuosity.The lesion had a 45% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon was noted to show leakage around 10 atm.The leak occurred 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.The balloon catheter advanced through the vessel without difficulty.It was noted that the powerflex balloon did have some difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The contrast/saline ratio was 1:2.The inflation device was used successfully with other devices during the procedure.The device was removed intact from the patient.The device will be returned for evaluation.

Event Description

As reported, radiographic agent was found to be extravasated during dilation with the powerflex pro 6mmx15cm.There was no reported injury to the patient.The patient has a long segment stenosis in the left superficial femoral artery (sfa).The unknown 5f sheath was punctured through the right femoral artery.After the angiography was done, that sheath was replaced with a 6f 40cm non-cordis sheath.A unknown guide wire passed through the lesion.The non-cordis balloon catheter was than expanded and the non-cordis stent and smart stent were placed.Stenosis remained after angiography was done.The powerflex pro 6x15 balloon was expanded posteriorly.This is when the extravasation was noted.A new powerflex pro 6x22 balloon was used and the flow rate of contrast was normal.The product stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion did not have any calcification.The vessel was noted to have a little tortuosity.The lesion had a 45% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon was noted to show leakage around 10 atm.The leak occurred 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.The balloon catheter advanced through the vessel without difficulty.It was noted that the powerflex balloon did have some difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The contrast/saline ratio was 1:2.The inflation device was used successfully with other devices during the procedure.The device was removed intact from the patient.The device will not be returned for evaluation as multiple attempts were made without success.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, h1, h2, h3 and h6.As reported, radiographic agent was found to be extravasated during dilation with the powerflex pro 6mm x 15cm.There was no reported injury to the patient.The patient has a long segment stenosis in the left superficial femoral artery (sfa).The unknown 5f sheath was punctured through the right femoral artery.After the angiography was done, that sheath was replaced with a 6f 40cm non-cordis sheath.An unknown guide wire passed through the lesion.The non-cordis balloon catheter was then expanded, and the non-cordis stent and smart stent were placed.Stenosis remained after angiography was done.The powerflex pro 6x15 balloon was expanded posteriorly.This is when the extravasation was noted.A new powerflex pro 6x22 balloon was used and the flow rate of contrast was normal.The product stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion did not have any calcification.The vessel was noted to have a little tortuosity.The lesion had a 45% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon was noted to show leakage around 10 atm.The leak occurred while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The balloon catheter advanced through the vessel without difficulty.It was noted that the powerflex balloon did have some difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The contrast/saline ratio was 1:2.The inflation device was used successfully with other devices during the procedure.The device was removed intact from the patient.The product was not returned for analysis.A product history record (phr) review of lot 82235778 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage-during positive pressure¿ was not confirmed as the device was not returned for analysis, the exact cause could not be determined.The device was used for post-dilation of an implanted stent as it was stated the leakage occurred inside the stent.Stent struts can easily damage balloon material if caution is not met when attempting to cross inside the stent and upon inflation.The vessel was also described as 45% stenosed; these characteristics may have also contributed to the events reported.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the safety information in the instructions for use ¿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.To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, radiographic agent was found to be extravasated during dilation with the powerflex pro 6mmx15cm.There was no reported injury to the patient.The patient has a long segment stenosis in the left superficial femoral artery (sfa).The unknown 5f sheath was punctured through the right femoral artery.After the angiography was done, that sheath was replaced with a 6f 40cm non-cordis sheath.A unknown guide wire passed through the lesion.The non-cordis balloon catheter was than expanded and the non-cordis stent and smart stent were placed.Stenosis remained after angiography was done.The powerflex pro 6x15 balloon was expanded posteriorly.This is when the extravasation was noted.A new powerflex pro 6x22 balloon was used and the flow rate of contrast was normal.The product stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion did not have any calcification.The vessel was noted to have a little tortuosity.The lesion had a 45% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon was noted to show leakage around 10 atm.The leak occurred 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.The balloon catheter advanced through the vessel without difficulty.It was noted that the powerflex balloon did have some difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The contrast/saline ratio was 1:2.The inflation device was used successfully with other devices during the procedure.The device was removed intact from the patient.The device was returned for evaluation.

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, radiographic agent was found to be extravasated during dilation with the powerflex pro 6mmx15cm.There was no reported injury to the patient.The patient has a long segment stenosis in the left superficial femoral artery (sfa).The unknown 5f sheath was punctured through the right femoral artery.After the angiography was done, that sheath was replaced with a 6f 40cm non-cordis sheath.An unknown guide wire passed through the lesion.The non-cordis balloon catheter was than expanded and a non-cordis stent and smart stent were placed.Stenosis remained after angiography was done.The powerflex pro 6x15 balloon was expanded posteriorly.This is when the extravasation was noted.A new powerflex pro 6x22 balloon was used and the flow rate of contrast was normal.The product stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion did not have any calcification.The vessel was noted to have a little tortuosity.The lesion had a 45% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon was noted to show leakage around 10 atm.The leak occurred 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.The balloon catheter advanced through the vessel without difficulty.It was noted that the powerflex balloon did have some difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The contrast/saline ratio was 1:2.The inflation device was used successfully with other devices during the procedure.The device was removed intact from the patient.The product was returned for analysis.A non-sterile powerflex pro 6mm15cm 135 percutaneous transluminal angioplasty (pta) unit was received for analysis inside a plastic bag.Per visual analysis, no anomalies could be observed on the unit by the naked eye.Per functional testing, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied.However, a leakage was observed at a rupture in the balloon distal area.No other anomalies were observed.Per microscopic analysis, sem was performed to identify the possible root cause of the balloon rupture.Results showed that the balloon of the powerflex pro 6mm15cm device presented evidence of a ruptured condition, scratch marks, and fatigue striations near the damaged area.These types of damages 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 and fatigue striations on these areas probably led to the damaged condition found on the received device.In addition, fatigue striations are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the ruptured area.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82235778 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ was confirmed via device analysis as a leakage was noted coming from a rupture on the distal area balloon surface.However, the exact cause cannot be determined.The outer surface of the balloon presented evidence of scratch marks and fatigue striations adjacent to the balloon rupture.The balloon material near the rupture, appears to have been punctured either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.The vessel characteristics were described as stenosed and the device was being used for post-stent dilation.It is likely these factors contributed to the event reported as evidenced by device analysis.Stent struts can easily damage balloon material when attempting to cross or upon inflation inside the stent.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 events for both devices.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, radiographic agent was found to be extravasated during dilation with the powerflex pro 6mmx15cm.There was no reported injury to the patient.The patient has a long segment stenosis in the left superficial femoral artery (sfa).The unknown 5f sheath was punctured through the right femoral artery.After the angiography was done, that sheath was replaced with a 6f 40cm non-cordis sheath.A unknown guide wire passed through the lesion.The non-cordis balloon catheter was than expanded and the non-cordis stent and smart stent were placed.Stenosis remained after angiography was done.The powerflex pro 6x15 balloon was expanded posteriorly.This is when the extravasation was noted.A new powerflex pro 6x22 balloon was used and the flow rate of contrast was normal.The product stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion did not have any calcification.The vessel was noted to have a little tortuosity.The lesion had a 45% stenosis.The device was not being used to treat a chronic total occlusion (cto).The balloon was noted to show leakage around 10 atm.The leak occurred 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.The balloon catheter advanced through the vessel without difficulty.It was noted that the powerflex balloon did have some difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The contrast/saline ratio was 1:2.The inflation device was used successfully with other devices during the procedure.The device was removed intact from the patient.The device was returned for evaluation.

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.

• Brand Name: POWERFLEXPRO 6MM15CM 135
• 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: 15093373
• MDR Text Key: 298290583
• Report Number: 9616099-2022-05843
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059623
• UDI-Public: (01)20705032059623(17)241130(10)82235778
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 10/27/2022

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: 4400615X
• Device Catalogue Number: 4400615X
• Device Lot Number: 82235778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 07/26/2022; 09/06/2022; 10/13/2022
• Supplement Dates FDA Received: 08/16/2022; 10/06/2022; 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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: 4X100 JIAHANG BALLOON; 6F 40 COOK LONG SHEATH; EVERFLEX 6X150; SMART 6X80 STENT; UNK 5F SHEATH; UNK GUIDEWIRE
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 76 KG