MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 6X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4206040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the powerflex p3 f5 6x4 balloon burst during inflation.The device was removed intact from the patient.The atm at which the balloon burst is unknown due the physician using a medallion syringe.The case was completed with the use of a new powerflex p3 balloon.There was no reported injury to the patient.The balloon did rupture while in the vessel.The balloon did not rupture while in a stent.The device was stored per the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted on the device prior to inserting into the patient.The device was prepped per the ifu.The vessel was noted to have had a little tortuosity and the lesion had a little calcification.The case being performed was a dialysis angioplasty.The lesion was noted to have an 80% stenosis.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing through the vessel.There was no difficulty crossing the lesion.The device was not in an acute bend and was never kinked during use.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82195717 presented no issues during the manufacturing process that can be related to the reported event.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 or Problem Description
As reported, the powerflex p3 f5 6x4 balloon burst during inflation.The device was removed intact from the patient.The atm at which the balloon burst is unknown due the physician using a medallion syringe.The case was completed with the use of a new powerflex p3 balloon.There was no reported injury to the patient.The balloon did rupture while in the vessel.The balloon did not rupture while in a stent.The device was stored per the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted on the device prior to inserting into the patient.The device was prepped per the ifu.The vessel was noted to have had a little tortuosity and the lesion had a little calcification.The case being performed was a dialysis angioplasty.The lesion was noted to have an 80% stenosis.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing through the vessel.There was no difficulty crossing the lesion.The device was not in an acute bend and was never kinked during use.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the powerflex p3 f5 6x4 balloon burst during inflation.The device was removed intact from the patient.The atm at which the balloon burst is unknown due the physician using a medallion syringe.The case was completed with the use of a new powerflex p3 balloon.There was no reported injury to the patient.The balloon did rupture while in the vessel.The balloon did not rupture while in a stent.The device was stored per the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted on the device prior to inserting into the patient.The device was prepped per the ifu.The vessel was noted to have had a little tortuosity and the lesion had a little calcification.The case being performed was a dialysis angioplasty.The lesion was noted to have an 80% stenosis and was not a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the guide catheter, advancing through the vessel, or crossing the lesion.The device was not in an acute bend and was never kinked during use.One product was returned for analysis.A non-sterile powerflex p3 f5 6x4 80 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a plastic bag.Per visual analysis, no anomalies were observed via naked eye.Per functional testing, a lab sample syringe 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.No other anomalies were observed.Per microscopic analysis, sem was performed to identify the possible root cause of the rupture.Results showed that the balloon of the powerflex p3 f5 6x4 80 presented evidence of a ruptured condition along with a scratch mark located in the external surface of 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 surface probably 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 resulting in the rupture of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82195717 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¿ was confirmed through analysis of the returned device.During functional analysis a leakage was noted from the balloon due to rupture of the balloon material.The outer surface of the balloon presented evidence of scratch marks adjacent to the rupture.The vessel was described as having little calcification and 80% stenosis.It is likely these vessel characteristics contributed to the reported event 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 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.¿ 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.

• Brand Name: POWERFLEX P3 F5 6X4 80
• 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: 15568395
• Report Number: 3009018440-2022-00016
• Device Sequence Number: 19538390
• Product Code: LIT
• UDI-Device Identifier: 20705032004432
• UDI-Public: (01)20705032004432(17)230531(10)82195717
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• 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): 11/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 4206040S
• Device Catalogue Number: 4206040S
• Device Lot Number: 82195717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/30/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• 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: NEW POWERFLEX P3 BALLOON
• Patient Sex: Unknown