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

Model Number 4156040S

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the 6 x 4 80cm powerflex extreme percutaneous transluminal angioplasty balloon catheter was found to have a hole in it when inserted in the patient.The contrast could be seen under fluoroscopy escaping the balloon.There was no patient injury reported.The intended procedure was a arteriovenous fistula.The lesion is not calcified.The device was not used for a chronic total occlusion (cto) case.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty in removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to insertion of the product to the patient.The device was prepped normally (i.E.Maintained negative pressure).Indeflator was used and it was also used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The leakage was noted at nominal pressure.The product was removed from the patient in one piece (intact).The catheter was never in an acute bend.The device was stored, handled and prepped as per the instructions for use (ifu).There were no damages noted to the packaging of the device prior to use.The procedure was completed using another powerflex pro balloon catheter.Other additional procedural details were requested but were unknown.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Carefully advance the catheter through a sheath or through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ based on the product history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

Event Description

As reported, the 6 x 4 80cm powerflex extreme percutaneous transluminal angioplasty balloon catheter was found to have a hole in it when inserted in the patient.The contrast could be seen under fluoro escaping the balloon.There was no patient injury reported.The intended procedure was arteriovenous fistula.The lesion is not calcified.The device was not used for a chronic total occlusion (cto) case.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty in removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to insertion of the product to the patient.The device was prepped normally (i.E.Maintained negative pressure).Indeflator was used and it was also used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The leakage was noted at nominal pressure.The product was removed from the patient in one piece (intact).The catheter was never in an acute bend.The device was stored, handled and prepped as per the instructions for use (ifu).There were no damages noted to the packaging of the device prior to use.The procedure was completed using another powerflex pro balloon catheter.The device will not be returned for evaluation.Other additional procedural details were requested but were unknown.

• Brand Name: POWERFLEX EXTREME 6X4 80CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9623612
• MDR Text Key: 191836983
• Report Number: 9616099-2020-03501
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032001752
• UDI-Public: 20705032001752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4156040S
• Device Catalogue Number: 4156040S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1