MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX EXTREME 6X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4156040S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a powerflex extreme balloon catheter (6x4 80cm) was delivered to the lesion in the juxta anastomosis, however, the balloon ruptured at 20 atmospheres (atms).The device was removed intact from the patient.The device was replaced with another powerflex extreme balloon catheter (6x4 80cm) and the procedure was successfully completed.There was no patient injury reported.The device was clinically used.The device has been discarded.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.No kinks or other damages were noted prior to inserting the product into the patient.The device prepped normally.The contrast media being used was ge omnipaque mixed 50/50 with saline.The inflation device being used was a non-cordis device.The same indeflator was used successfully with other devices.There was no resistance/friction encountered while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction encountered while inserting the balloon through the guide catheter.The sheath being used was a non-cordis device.The guide wire being used was a non-cordis device.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 device did not have to pass through a previously placed stent.The balloon did not seem to ¿stick¿ to a stent.The balloon was inflated once.The balloon catheter did not kink while being used.The type of rupture was longitudinal.The vessel and/or tracking path were not calcific or tortuous in nature.

Manufacturer Narrative

Complaint conclusion: a powerflex extreme balloon catheter (6x4 80cm) was delivered to the lesion in the juxta anastomosis; however, the balloon ruptured at 20 atmospheres (atms).The type of rupture was longitudinal.The device was removed intact from the patient.The device was replaced with another powerflex extreme balloon catheter (6x4 80cm) and the procedure was successfully completed.There was no patient injury reported.Non-cordis contrast media was used mixed 50/50 with saline.A non-cordis inflation device, sheath and guidewire were used during the procedure.The same indeflator was used successfully with other devices.There was no resistance/friction encountered while inserting the balloon through the rotating hemostatic valve, through the guide catheter or advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The device did not have to pass through a previously placed stent.The balloon did not seem to ¿stick¿ to a stent.The balloon was inflated once and did not kink while being used.The vessel and/or tracking path were not calcific or tortuous in nature.There was no difficulty removing the product from the protective balloon cover ,the hoop, removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device prepped normally.The product was not returned for analysis.A product history record (phr) review of lot 82159250 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.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.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 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.

• Brand Name: POWERFLEX EXTREME 6X4 80CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8628749
• MDR Text Key: 145670133
• Report Number: 9616099-2019-02977
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032001752
• UDI-Public: 20705032001752
• Combination Product (y/n): N
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 4156040S
• Device Catalogue Number: 4156040S
• Device Lot Number: 82159250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1