MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 4X4 80CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4154040S

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the operator attempted to inflate a 4mm x 4mm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter; however, s/he noticed a leak and the balloon would not inflate. Therefore, it was removed and discarded, and an additional product (unknown) was opened and used to finish the case. The powerflex extreme was opened on the sterile table as per instructions for use (ifu). It was inserted over an unknown wire. The intended procedure was a fistulagram. Leakage was noted from the balloon. A. 035 unknown guidewire was used. The lesion was not calcified or tortuous. The device was not used for a chronic total occlusion (total occlusion >3 months). There was difficulty no removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components. There were no kinks nor other damages noted prior to inserting the product into the patient. The contrast to saline ratio was 50/50. A syringe inflation device was used. 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 advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The plunger was depressed into the syringe/indeflator when trying to inflate. The balloon catheter did not kink while being used. The balloon catheter was removed easily. The product was removed intact (in one piece) from the patient. Another powerflex extreme balloon was used to complete the procedure. The product was not returned for analysis as it was discarded at the facility. A product history record (phr) review of lot 82208638 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon leakage-during positive pressure¿ was not confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics and procedural factors likely contributed to the reported event as the device was intended for a fistulagram procedure. Arteriovenous fistulas are often scarred and fibrous in nature and often resistant to balloon expansion increasing the likelihood of damage to the balloon. However, 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 ¿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. To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. 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. ¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process. Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the operator attempted to inflate a 4mm x 4mm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter; however, s/he noticed a leak and the balloon would not inflate. Therefore, it was removed and discarded, and an additional product (unknown) was opened and used to finish the case. The powerflex was opened on the sterile table as per instructions for use (ifu). It was inserted over an unknown wire. The intended procedure was a fistulagram. Leakage was noted from the balloon. A. 035 unknown guidewire was used. The lesion was not calcified or tortuous. The device was not used for a chronic total occlusion (total occlusion >3 months). There was difficulty no removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components. There were no kinks nor other damages noted prior to inserting the product into the patient. The contrast to saline ratio was 50/50. A syringe inflation device was used. 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 advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The plunger was depressed into the syringe/indeflator when trying to inflate. The balloon catheter did not kink while being used. The balloon catheter was removed easily. The product was removed intact (in one piece) from the patient. Another powerflex extreme balloon was used to complete the procedure. The device will not be returned for evaluation as it was already discarded at the facility.

• Brand Name: POWERFLEX EXTREME 4X4 80CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12803340
• MDR Text Key: 285475313
• Report Number: 3009018440-2021-00002
• Device Sequence Number: 1
• Product Code: LIT
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4154040S
• Device Catalogue Number: 4154040S
• Device Lot Number: 82208638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/12/2021 Patient Sequence Number: 1

Treatment

UNKNOWN WIRE