MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO POWERFLEX EXTREME 6X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported to be available for analysis but has not yet been returned.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During an interventional procedure, a 6x4 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured as it was starting to inflate at 4atm.There procedure was successfully completed with a different balloon.There was no reported patient injury and the device will be returned for analysis.The lesion was flistula.There was no calcification and no vessel tortuosity.A fistulagram procedure was being performed.The access site was the left arm.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The contrast media ratio of contrast to saline ratio was 30/70.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.It was easily removed.Additional patient information was requested but was not available.
Additional Manufacturer Narrative
During an interventional procedure, a 6 x 4 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured as it was starting to inflate at four atm.The procedure was successfully completed with a different balloon.There was no reported patient injury.The lesion was fistula and there was no calcification and no vessel tortuosity.A fistulagram procedure was being performed.The access site was the left arm.There was no difficulty removing the 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 prepped normally.The contrast media ratio of contrast to saline ratio was 30/70.The same indeflator 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.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.It was easily removed.Additional patient information was requested but was not available.The device was not returned for evaluation.A product history record (phr) review of lot 82215118 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors likely contributed to the reported event as the device was intended for a fistulagram procedure.Arteriovenous fistulas are often scarred and fibrous in nature and often resistant to balloon expansion increasing the likelihood of damage to the balloon.However, with the information available and without return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event.According to the safety information in the instructions for use ¿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.

• Brand Name: POWERFLEX EXTREME 6X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 12605862
• Report Number: 9616099-2021-04919
• Device Sequence Number: 16484115
• Product Code: LIT
• UDI-Device Identifier: 20705032001752
• UDI-Public: (01)20705032001752(17)240131(10)82215118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 4156040S
• Device Lot Number: 82215118
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OMNIPAQUE 300 MGI/ML AND BARD PRESTO INFLATION DEV