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

Model Number	4157040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 7mm x 40mm powerflex extreme percutaneous transluminal angioplasty (pta) dilatation catheter ruptured at eight atmospheres (atm).The balloon was delivered and removed upon rupture without incident.There was no patient injury reported.The device was inspected outside the patient and confirmed to be punctured.It was used intending to dilate a lesion in the cephalic vein.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was eighty.The device was used for a chronic total occlusion.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped normally according to the ifu.The device was of normal appearance prior to use.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The balloon catheter did not kink while being used.The contrast to saline ratio was 50%.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.There was no unusual force used at any time during the procedure.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The procedure was completed without complications.The product was not returned for analysis.A product history record (phr) review of lot 82159243 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.However, vessel characteristics and procedural factors may have contributed to the reported event.The lesion was a chronic total occlusion with eighty percent stenosis, it is likely these factors contributed to the stated ¿puncture¿ noted to the balloon upon inspection.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/preventive action will be taken at this time.
Event or Problem Description
As reported, a 7 x 40 mm powerflex extreme percutaneous transluminal angioplasty (pta) dilatation catheter ruptured at 8 atmosphere (atm).The balloon was delivered without incident and removed upon rupture without incident.There was no patient injury reported.The device was inspected outside the patient and confirmed to be punctured.It was used intending to dilate a lesion in the cephalic vein.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was 80 %.The device was used for a chronic total occlusion.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.The device was prep normally.There was nothing unusual noted about the device prior to use.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.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 balloon catheter did not kink while being used.The contrast to saline ratio was 50%.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon ruptured at 8 atm.There was no unusual force used at any time during the procedure.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The procedure was completed without complications.

• Brand Name: POWERFLEX EXTREME 7X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8736471
• Report Number: 9616099-2019-03039
• Device Sequence Number: 11356466
• Product Code: LIT
• UDI-Device Identifier: 20705032001837
• UDI-Public: 20705032001837
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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 Model Number: 4157040S
• Device Catalogue Number: 4157040S
• Device Lot Number: 82159243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60
• Patient Weight: 85