MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 7X10 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4207000S

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: the balloon of a 7mm x 10cm 80cm powerflex p3 f5 percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal pressure.As a result, a new 7mm x 10cm 80cm powerflex p3 balloon catheter was used in place of the 7mm x 10cm 80cm powerflex p3 pta balloon catheter and was used without issue.This was during a procedure to treat a fistula lesion which had an 80% stenosis but showed no signs of chronic total occlusion (cto), calcification, or tortuosity.There was no reported injury to the patient.A non-cordis.035 guidewire was used for the procedure without issue.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction during insertion of the device.The device was able to track toward the lesion and cross the lesion without difficulty.The device was never put into an acute bend and did not kink during its use.After the rupture occurred, the device was able to be removed easily and remained in one piece during its removal.The product was not returned for analysis.A product history record (phr) review of lot 82227787 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.Procedural factors or lesion characteristics may have contributed to the reported event.According to the safety information in 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 review nor the information provided suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, the balloon of a 7mm x 10cm 80cm powerflex p3 f5 percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal pressure.As a result, a new 7mm x 10cm 80cm powerflex p3 balloon catheter was used in place of the 7mm x 10cm 80cm powerflex p3 pta balloon catheter and was used without issue.There was no reported injury to the patient.This was during a procedure to treat a fistula lesion which had an 80% stenosis but showed no signs of chronic total occlusion (cto), calcification, or tortuosity.A non-cordis.035 guidewire was used for the procedure without issue.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction during insertion of the device.The device was able to track toward the lesion and cross the lesion without difficulty.The device was never put into an acute bend and did not kink during its use.After the rupture occurred, the device was able to be removed easily and remained in one piece during its removal.The device was discarded and will not be returned.

• Brand Name: POWERFLEX P3 F5 7X10 80
• 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 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14976318
• MDR Text Key: 304542000
• Report Number: 3009018440-2022-00012
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032004517
• UDI-Public: (01)20705032004517(17)240630(10)82227787
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4207000S
• Device Catalogue Number: 4207000S
• Device Lot Number: 82227787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Date Device Manufactured: 07/20/2021
• 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
• Treatment: 7MM X 10CM 80CM POWERFLEX P3 PTA BALLOON CATHETER; UNK WIRE (.035)
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 86 KG