MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX EXTREME 8X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4158040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82159241 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, while attempting to inflate the 8x4 80cm powerflex extreme percutaneous transluminal angioplasty (pta) device in the cephalic vein, contrast was observed to be leaking out from the balloon.The balloon was removed intact and inspected outside of the patient.Contrast was observed to be leaking from the balloon.There was no reported patient injury.The powerflex was attempted to be used during an angioplasty procedure.The lesion was not calcified, had no tortuosity, was not a chronic total occlusion (cto), but had a rate of stenosis of 90%.The device was stored and handled per the instructions for use (ifu).There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The device was prepped per the ifu and prepped normally (i.E.Maintained negative pressure).The contrast to saline ratio was 50% contrast 50% normal saline.The merit indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and there was no difficulty crossing the lesion.
Additional Manufacturer Narrative
While attempting to inflate the 8mm x 4cm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) device in the cephalic vein, contrast was observed to be leaking out from the balloon.The balloon was removed intact and inspected outside of the patient.Contrast was observed to be leaking from the balloon.There was no reported patient injury.The powerflex was attempted to be used during an angioplasty procedure.The lesion was not calcified, had no tortuosity, was not a chronic total occlusion (cto), but had a rate of stenosis of 90%.The device was stored and handled per the instructions for use (ifu).There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The device was prepped per the ifu and prepped normally (i.E.Maintained negative pressure).The contrast to saline ratio was 50% contrast 50% normal saline.A non-cordis indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and there was no difficulty crossing the lesion.One product was returned for analysis.A non-sterile powerflex extreme 8mm x 4cm x 80cm catheter was returned.Per visual analysis, the balloon was received deflated and coiled inside a plastic bag.No anomalies were observed in the returned device.Functional analysis was performed.A lab sample inflator/deflator filled with water was attached to the inflation lumen of the unit and successfully inflated.No leakage or any other anomaly was observed during the inflation test.A product history record (phr) review of lot 82159241 revealed no anomalies or non-conformance during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-leakage¿ was not confirmed by analysis of the returned device.The unit was successfully inflated with no other anomalies noted to the device.The exact cause of the reported event could not be determined as the device passed functional analysis.It is difficult to draw a clinical conclusion between the device and the event reported as the device performed as intended.However, vessel characteristics and procedural factors may have contributed to 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 (b)(4) of the balloons (with a (b)(4) 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/preventive action will be taken at this time.

• Brand Name: POWERFLEX EXTREME 8X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8585846
• Report Number: 9616099-2019-02903
• Device Sequence Number: 1586841
• Product Code: LIT
• UDI-Device Identifier: 20705032001943
• UDI-Public: 20705032001943
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 08/31/2021
• Device Catalogue Number: 4158040S
• Device Lot Number: 82159241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/18/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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: BASIXCOMPAX FROM MERIT; OMNIPAQUE FROM GE HEALTH; BASIXCOMPAX FROM MERIT; OMNIPAQUE FROM GE HEALTH