MAUDE Adverse Event Report: CORDIS US. CORP POWERFLEX EXTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4158040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of an 8mm x 4cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 15 atmospheres (atm).A second 8mm x 40mm powerflex extreme pta balloon catheter was used as a replacement.There were no reported injuries to the patient.This was during a procedure to treat a greater than 70% stenosed fistula lesion which had moderate calcification but no signs of tortuosity.The device was stored, handled, and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.An 80% saline and 20% contrast mixture was used to prep the device.The device was able to be removed easily from the patient and remained in one piece during its removal.The device was discarded and will not be returned.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82251090 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of an 8mm x 4cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 15 atmospheres (atm).A second 8mm x 40mm powerflex extreme pta balloon catheter was used as a replacement.There were no reported injuries to the patient.This was during a procedure to treat a greater than 70% stenosed fistula lesion which had moderate calcification but no signs of tortuosity.The device was stored, handled, and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.An 80% saline and 20% contrast mixture was used to prep the device.The device was able to be removed easily from the patient and remained in one piece during its removal.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 82251090 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.Vessel characteristics and procedural factors likely contributed to the reported event as the device was intended for a stenosed fistula lesion with moderate calcification.Arteriovenous fistulas are often scarred and fibrous in nature and often resistant to balloon expansion increasing the likelihood of damage to the balloon.However, without the 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 ¿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 or preventive action will be taken at this time.

• Brand Name: POWERFLEX EXTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 18865203
• Report Number: 3007635982-2024-00057
• Device Sequence Number: 8282754
• Product Code: LIT
• UDI-Device Identifier: 20705032001943
• UDI-Public: (01)20705032001943(17)250430(10)82251090
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 4158040S
• Device Lot Number: 82251090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 7F BOSTON SCIENTIFIC
• Patient Age: 53 YR
• Patient Sex: Female