MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 12X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4202040S

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

As reported, the balloon of a 12mm x 4cm 80cm powerflex p3.035 percutaneous transluminal angioplasty (pta) balloon catheter was unable to be inflated and a leak was observed at the distal balloon tip.There was no reported injury to the patient.Additional information was requested but is unavailable, and the device will not be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received.Complaint conclusion: as reported, the balloon of a 12mm x 4cm 80cm powerflex p3.035 percutaneous transluminal angioplasty (pta) balloon catheter was unable to be inflated and a leak was observed at the distal balloon tip.There was no reported injury to the patient.Additional information was requested but is unavailable.The device was not returned for evaluation.A product history record (phr) review of lot 82227796 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, although unknown, may have contributed to the reported event.However, with the limited amount of information provided regarding lesion characteristics and 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, 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.¿ 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.

• Brand Name: POWERFLEX P3 F5 12X4 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: 14073278
• MDR Text Key: 290097116
• Report Number: 9616099-2022-05535
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032003961
• UDI-Public: (01)20705032003961(17)240731(10)82227796
• 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,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 4202040S
• Device Catalogue Number: 4202040S
• Device Lot Number: 82227796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/05/2022
• Date Device Manufactured: 08/11/2021
• 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