MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 5X4 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4205040T

Device Problems Balloon (419); Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  Malfunction  

Manufacturer Narrative

The 5f 5mm x 4mm x 40cm powerflex p3 percutaneous transluminal angioplasty (pta) dilatation catheter was inflated in the anatomic part with stenosis; however, it ruptured within its nominal pressure. This was a shunt percutaneous transluminal angioplasty (pta) case and was completed using a new non-cordis balloon catheter. There was no reported patient injury. The intended procedure was anastomotic stenosis which has severe acute angulation. The lesion had ninety nine percent of stenosis and no calcification. The device was stored, handled and prepped per the instructions for use (ifu). There was no difficulty removing the product from the hoop, the protective balloon cover, 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 catheter was passed with finger support from the body surface. The contrast to saline ratio was 1:1. A cordis indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel. The product was removed intact (in one piece) from the patient. The device was not returned for analysis as it was discarded. A product history record (phr) review of lot 82160256 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. The procedure performed was a shunt percutaneous transluminal angioplasty (pta) case. Arteriovenous shunts are often scarred and fibrous in nature and therefore often resistant to balloon expansion increasing the likelihood of damage to the balloon. However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported. According to the instructions for use ¿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 nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the 5f 5 x 4 mm x 40 cm powerflex p3 percutaneous transluminal angioplasty (pta) dilatation catheter was inflated in the anatomic part with stenosis however, it ruptured within its nominal pressure. The procedure completed using a new non-cordis balloon catheter. There was no reported patient injury. This was a shunt percutaneous transluminal angioplasty (pta) case. The device was stored and handled per the instructions for use (ifu). The device was prepped according to the ifu. The intended procedure was anastomotic stenosis which has severe acute angulation. The lesion had ninety nine percent of stenosis and no calcification. 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. There were no kinks nor other damages noted prior to inserting the product into the patient. The catheter was passed with finger support from the body surface. The contrast to saline ratio was 1:1. A cordis indeflator 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 resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel. The product was removed intact (in one piece) from the patient. The device will not be returned for analysis as it was discarded.

• Brand Name: POWERFLEX P3 F5 5X4 40
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9524551
• MDR Text Key: 203306464
• Report Number: 9616099-2019-03434
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/27/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 4205040T
• Device LOT Number: 82160256
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 09/17/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial