MAUDE Adverse Event Report: CORDIS CORPORRATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: balloon catheter (7*40 ultraverse, c.R.Bard), brite tip sheath 6fr-11cm, guidewire- vassallo floppy 300 (filmec).Telephone number is : (b)(6).The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During post-dilatation of an 8x40 smart stent that was deployed in the left external iliac artery with a 7mm4cm 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter, the balloon ruptured within nominal pressure.It was replaced with a non cordis pta catheter and the procedure was completed.There was no patient injury and the device was discarded by mistake.Initial approach to the lesion was made from the left femoral artery.The powerflex pro was used for pre-dilation and the smart stent was implanted.The lesion was a 100% occluded chronic total occlusion with severe calcification (70%) and mild vessel tortuosity.There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and 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 the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no difficulty crossing the lesion and the catheter was never in an acute bend.Additional procedural details were requested but were not available.

Manufacturer Narrative

During post-dilatation of an 8x40 smart stent that was deployed in the left external iliac artery with a 7mm4cm 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter, the balloon ruptured within nominal pressure.It was replaced with a non-cordis pta catheter and the procedure was completed.There was no patient injury.Initial approach to the lesion was made from the left femoral artery.The powerflex pro was used for pre-dilation and the smart stent was implanted.The lesion was a 100% occluded chronic total occlusion (cto) with severe calcification (70%) and mild vessel tortuosity.There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover, and 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 device prepped normally.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no difficulty crossing the lesion and the catheter was never in an acute bend.Additional procedural details were requested but were not available.The device was not returned for analysis as it was discarded by mistake.A product history record (phr) review of lot 82157745 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis, the reported ¿balloon-burst - at/below rbp¿ could not be confirmed and the exact root cause could not be determined.Vessel characteristics (cto, severe calcification, mild vessel tortuosity) may have contributed to the reported event.According to the safety information in the instructions for use (ifu), which is not intended as a mitigation of risk, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.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 review 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: POWERFLEXPRO 7MM4CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORRATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9180403
• MDR Text Key: 195586017
• Report Number: 9616099-2019-03269
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 4400704S
• Device Lot Number: 82157745
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR