MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 5X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4155040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 5mm x 40mm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured upon first inflation at 15atm (atmospheres) while attempting to dilate a lesion in an arterial anastomosis.The balloon was removed intact.There was no reported patient injury.The device was prepped as per the instruction for use (ifu).The balloon was delivered without incident.The device was stored and handled per the instructions for use (ifu).The device was prepped normally, by maintaining negative pressure.There was no difficulty removing the product from the hoop and removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The contrast media used was non-cordis and the contrast to saline ratio was 50:50.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon inflated normally.The balloon was removed intact.An unknown cordis device was used to complete the procedure.The product was not returned for analysis.A product history record (phr) review of lot 82179274 revealed no anomalies or non-conformance's 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 of an arterial anastomosis which may be fibrosed and calcified from frequent needling 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 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 limited 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 5mm x 40mm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured upon first inflation at 15 atmospheres (atm) while attempting to dilate a lesion in an arterial anastomosis.The balloon was removed intact.There was no reported patient injury.The device was prepped as per the instruction for use (ifu).The balloon was delivered without incident.The device was stored and handled per the instructions for use (ifu).The device was prepped normally, by maintaining negative pressure.There was no difficulty removing the product from the hoop and removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The contrast media used was ge omnipaque and the contrast to saline ratio was 50:50.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon inflated normally.The balloon was removed intact.An unknown cordis device was used to complete the procedure.The device will not be returned for evaluation as it was discarded.

• Brand Name: POWERFLEX EXTREME 5X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10246595
• Report Number: 9616099-2020-03776
• Device Sequence Number: 594905
• Product Code: LIT
• UDI-Device Identifier: 20705032001684
• UDI-Public: 20705032001684
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: 09/30/2022
• Device Model Number: 4155040S
• Device Catalogue Number: 4155040S
• Device Lot Number: 82179274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1