MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400804X

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

This report is related to report 9616099-2022-05489.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloons of two powerflex pro 8mm 4cm 135 ruptured at approx 5 atms while inflating in the left common iliac artery.The case was completed with a non-cordis balloon catheter.There was no reported injury to the patient.The balloons were stored and used per ifu and under sterile technique.The device was prepper per the ifu.The device was prepped normally and was able to maintain negative pressure.There was no difficulty removing the device from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or damages noted prior to inserting the device into the patient.The lesion had a 55-65% stenosis as the device was not being used to treat a chronic total occlusion.The lesion was moderately calcified and non-tortuous.The non-cordis inflation device was filled with 40/60 contrast/saline ratio.Isovue 300 was used to fill the inflation device.The inflation device used was used successfully with other devices.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 catheter was never in an acute bend nor was the catheter ever kinked while being used.Both products had no issue crossing lesions and no resistance was met on insertion or removal.The device was removed from the patient intact (in one piece).The devices will be returned for evaluation.

Manufacturer Narrative

This report is related to report # 9616099-2022-05489.As reported, the balloons of two powerflex pro 8mm x 4cm 135 ruptured at approx.Five atms while inflating in the left common iliac artery.The case was completed with a non-cordis balloon catheter.There was no reported injury to the patient.The balloons were stored and used per ifu and under sterile technique.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.There was no difficulty removing the device from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or damages noted prior to inserting the device into the patient.The lesion had a 55-65% stenosis as the device was not being used to treat a chronic total occlusion.The lesion was moderately calcified and non-tortuous.The non-cordis inflation device was filled with 40/60 contrast/saline ratio.Isovue 300 was used to fill the inflation device.The inflation device used was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The catheter was never in an acute bend nor was the catheter ever kinked while being used.Both products had no issue crossing lesions and no resistance was met on insertion or removal.The devices were removed from the patient intact (in one piece).The product was returned for analysis.Two non-sterile powerflex pro 8mm x 4cm 135 percutaneous transluminal angioplasty (pta) units were received for analysis inside a plastic bag.The unit identified as unit number two was analyzed under this complaint (b)(4).Per visual analysis of the unit number two, no damages were observed 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.A balloon leakage was observed coming from a rupture in the proximal section of the balloon.No other anomalies were observed.Per microscopic analysis, sem analysis was performed.Results showed that the leakage on the balloon of the powerflex pro 8mm x 4cm 135 device presented evidence of a ruptured condition and scratch marks near the damaged area on the balloon.This type of damage is 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 with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82235799 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¿ were confirmed via device analysis as a leakage was noted during functional analysis for both devices.However, the exact cause cannot be determined.A rupture was noted on the proximal section of both balloons.The outer surfaces of the balloon material presented evidence of scratch marks adjacent to the ruptures noted.It is likely vessel characteristics of stenosis and moderate calcification likely contributed to the reported events as evidenced by device analysis.The balloon material near the rupture, appears to have been torn 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.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 balloons of two powerflex pro 8mm 4cm 135 ruptured at approx 5 atms while inflating in the left common iliac artery.The case was completed with a non-cordis balloon catheter.There was no reported injury to the patient.The balloons were stored and used per ifu and under sterile technique.The device was prepper per the ifu.The device was prepped normally and was able to maintain negative pressure.There was no difficulty removing the device from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or damages noted prior to inserting the device into the patient.The lesion had a 55-65% stenosis as the device was not being used to treat a chronic total occlusion.The lesion was moderately calcified and non-tortuous.The non-cordis inflation device was filled with 40/60 contrast/saline ratio.Isovue 300 was used to fill the inflation device.The inflation device used was used successfully with other devices.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 catheter was never in an acute bend nor was the catheter ever kinked while being used.Both products had no issue crossing lesions and no resistance was met on insertion or removal.The device was removed from the patient intact (in one piece).The devices will be returned for evaluation.

• Brand Name: POWERFLEXPRO 8MM4CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13996258
• MDR Text Key: 290463818
• Report Number: 9616099-2022-05490
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059821
• UDI-Public: (01)20705032059821(17)241130(10)82235799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4400804X
• Device Catalogue Number: 4400804X
• Device Lot Number: 82235799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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: ARMADA BALLOON.; BOSTON SCIENTIFIC ENCORE 26-INFLATION DEVICE.; BOSTON SCIENTIFIC ENCORE 26-INFLATION DEVICE.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 107 KG