MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 7X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4157040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the powerflex extreme 7x4 balloon would not inflate to nominal and contrast leakage was noticed in the vessel from the balloon.The leak was noticed while giving positive pressure.The leak was noticed at 1atm.The device was removed intact and discarded.An additional/second powerflex extreme device of same size was opened and used; however, the new device also had contrast leakage.That device was removed intact and discarded.The case was completed with an additional powerflex extreme balloon.The devices were opened and prepped in a sterile field per the instructions for use (ifu).The device was noted to have maintained negative pressure.The devices tracked over the unknown wire to the desired lesion.There was no difficulty removing the products from the hoop, removing the protective balloon covers, stylets, or any of the sterile packaging components.There were no kinks or other damages prior to inserting the devices into the patient.The devices were not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloons through the rotating hemostatic valve, or while inserting through the guide catheter.There was no difficulty advancing the devices through the vessel.There was no difficulty crossing the lesion.The catheters were never in an acute bend and were never kinked during use.The inflation was done with 50/50 contrast/saline ratio.The inflation device was used successfully with other devices during the procedure.Both devices were discarded at the facility.
Additional Manufacturer Narrative
This is one of two products involved with the reported event and the associated manufacturer report number is: 3009018440-2022-00019.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the powerflex extreme 7x4 balloon would not inflate to nominal and contrast leakage was noticed in the vessel from the balloon.The leak was noticed while giving positive pressure.The leak was noticed at 1atm.The device was removed intact and discarded.An additional/second powerflex extreme device of same size was opened and used; however, the new device also had contrast leakage.That device was removed intact and discarded.The case was completed with an additional powerflex extreme balloon.The devices were opened and prepped in a sterile field per the instructions for use (ifu).The device was noted to have maintained negative pressure.The devices tracked over the unknown wire to the desired lesion.There was no difficulty removing the products from the hoop, removing the protective balloon covers, stylets, or any of the sterile packaging components.There were no kinks or other damages prior to inserting the devices into the patient.The devices were not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloons through the rotating hemostatic valve, or while inserting through the guide catheter.There was no difficulty advancing the devices through the vessel.There was no difficulty crossing the lesion.The catheters were never in an acute bend and were never kinked during use.The inflation was done with 50/50 contrast/saline ratio.The inflation device was used successfully with other devices during the procedure.Both devices were discarded at the facility.
Additional Manufacturer Narrative
This report is related to report # 3009018440-2022-00019.After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, h1, h2, h3 and h6.As reported, the powerflex extreme 7x4 balloon would not inflate to nominal and contrast leakage was noticed in the vessel from the balloon.The leak was noticed while giving positive pressure.The leak was noticed at one atm.The device was removed intact and discarded.An additional/second powerflex extreme device of same size was opened and used; however, the new device also had contrast leakage.That device was removed intact and discarded.The case was completed with an additional powerflex extreme balloon.The devices were opened and prepped in a sterile field per the instructions for use (ifu).The device was noted to have maintained negative pressure.The devices tracked over the unknown wire to the desired lesion.There was no difficulty removing the products from the hoop, removing the protective balloon covers, stylets, or any of the sterile packaging components.There were no kinks or other damages prior to inserting the devices into the patient.The devices were not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloons through the rotating hemostatic valve, or while inserting through the guide catheter.There was no difficulty advancing the devices through the vessel.There was no difficulty crossing the lesion.The catheters were never in an acute bend and were never kinked during use.The inflation was done with 50/50 contrast/saline ratio.The inflation device was used successfully with other devices during the procedure.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82226907 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¿ were not confirmed as the devices were not returned for analysis, the exact cause could not be determined.It is likely that procedural factors or handling of the products may have contributed to the reported event.However, without the return of the devices for analysis and with the limited information provided regarding lesion characteristics, it is difficult to draw a clinical conclusion between the devices and the events 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.

• Brand Name: POWERFLEX EXTREME 7X4 80CM
• Common Device Name: 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: 15952100
• Report Number: 3009018440-2022-00020
• Device Sequence Number: 15279521
• Product Code: LIT
• UDI-Device Identifier: 20705032001837
• UDI-Public: (01)20705032001837(17)240731(10)82226907
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 4157040S
• Device Catalogue Number: 4157040S
• Device Lot Number: 82226907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/09/2023
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POWERFLEX EXTREME CATH; UNK WIRE
• Patient Sex: Unknown