MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401004X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During use of the powerflex pro balloon catheter, when the pressure pump was used to inflate the balloon, the pressure could not reach five atmosphere (5 atm).When the balloon was removed from the patient's body, it was found that the balloon leaked at many places.There is no patient injury.The powerflex pro was replaced with another powerflex pro to complete the procedure.The procedure was an arterial thrombosis of the lower extremity which was not occluded in the previous three months.The powerflex pro was prepped according to the instruction for use (ifu) with no anomalies noted.The same inflator device used was successfully used with other devices.When the pressure pump was used to inflate the balloon, the pressure could not reach 5 atm.When the balloon was removed from the patient's body, it was found that the balloon leaked at many places.The device was replaced with another powerflex pro to complete the procedure.The device is available for analysis.No other information was provided.
Additional Manufacturer Narrative
Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
During use of the powerflex pro balloon catheter, when the pressure pump was used to inflate the balloon, the pressure could not reach five atmosphere (5 atm).When the balloon was removed from the patient's body, it was found that the balloon leaked at many places.There is no patient injury.The powerflex pro was replaced with another powerflex pro to complete the procedure.The procedure was an arterial thrombosis of the lower extremity which was not occluded in the previous three months.The powerflex pro was prepped according to the instruction for use (ifu) with no anomalies noted.The same inflator device used was successfully used with other devices.When the pressure pump was used to inflate the balloon, the pressure could not reach five atm.The device was replaced with another powerflex pro to complete the procedure.The product was not returned for analysis.A product history record (phr) review of lot 82219806 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¿ could not be 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.Damage to balloon material may occur when attempting to cross a calcified lesion or during inflation.However, without the return of the device for analysis, it is difficulty to draw a clinical conclusion between the device and the events reported.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.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 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 10MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13044280
• Report Number: 9616099-2021-05207
• Device Sequence Number: 13890972
• Product Code: LIT
• UDI-Device Identifier: 20705032060063
• UDI-Public: 20705032060063
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 4401004X
• Device Catalogue Number: 4401004X
• Device Lot Number: 82219806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown