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

Catalog Number	4400415X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 4mm x 15cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured during the procedure.The device was not available and there were no reported injuries to the patient.This was during a pta procedure.The target vessel was the superficial femoral artery (sfa).The target site vessel characteristics included mild tortuosity and 70% stenosis with no signs of calcification.The device was stored, prepared, and used per the instructions for use (ifu).There were no visible signs of damage to the device or device packaging prior to use.The physician achieved certification on the use of the powerflex pro balloon catheter and has used the device several times prior to this procedure.There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The contrast to saline ratio used was 1:1.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the balloon of a 4mm x 15cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured during the procedure.The device was not available and there were no reported injuries to the patient.This was during a pta procedure.The target vessel was the superficial femoral artery (sfa).The target site vessel characteristics included mild tortuosity and 70% stenosis with no signs of calcification.The device was stored, prepared, and used per the instructions for use (ifu).There were no visible signs of damage to the device or device packaging prior to use.The physician achieved certification on the use of the powerflex pro balloon catheter and has used the device several times prior to this procedure.There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The contrast to saline ratio used was 1:1.A non-sterile unit of ¿powerflexpro 4mm15cm 135¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.A thorough inspection was performed observing an axial burst on the balloon.No other outstanding details were observed.Functional testing was not performed due to the condition the unit was received.The balloon was inspected with a vision system observing a rupture on the surface where the water is leaking.The balloon surface presented evidence of a rupture condition with elongations and secondary scratch marks located near the damaged border area.The reported event of ¿balloon burst¿ was observed through analysis of the returned device since an axial burst was noted on the balloon during analysis.The exact cause of the issue experienced could not be conclusively determined during analysis.Unspecified procedural, handling, and/or anatomical factors may have contributed to the reported issue.However, this type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and elongations on the surface could probably lead to the damaged condition found on the received device.It seems that the material near the damaged area was affected by a sharp object from the outside of the device.It is possible that the tortuosity and stenosis reported led to balloon damage.As per the ifu, use only the recommended balloon inflation medium of 50/50 contrast/saline.The catheter should only be used by trained physicians.Balloon inflation should be performed with the guidewire extended beyond the catheter tip.Inflation at high-rate may damage the balloon.If at any point during insertion of the catheter resistance is felt, withdraw the entire system.Based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
Event or Problem Description
As reported, the balloon of a 4mm x 15cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured during the procedure.The device was not available and there were no reported injuries to the patient.This was during a pta procedure.The target vessel was the superficial femoral artery (sfa).The target site vessel characteristics included mild tortuosity and 70% stenosis with no signs of calcification.The device was stored, prepared, and used per the instructions for use (ifu).There were no visible signs of damage to the device or device packaging prior to use.The physician achieved certification on the use of the powerflex pro balloon catheter and has used the device several times prior to this procedure.There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The contrast to saline ratio used was 1:1.The device will be returned for evaluation.

• Brand Name: POWERFLEX PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• 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: 22715790
• Report Number: 3007635982-2025-00169
• Device Sequence Number: 15847199
• Product Code: LIT
• UDI-Device Identifier: 20705032059258
• UDI-Public: (01)20705032059258(17)250731(10)82255803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 07/31/2025
• Device Catalogue Number: 4400415X
• Device Lot Number: 82255803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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: UNKNOWN.
• Patient Sex: Unknown