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

Catalog Number	4400404S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 4mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 6 atmospheres (atm).An unknown device was used as a replacement and was inflated without issue.There were no reported injuries to the patient.This was during a procedure to treat a superficial femoral artery (sfa) lesion, a non-cordis.035 guidewire was inserted across the lesion prior to the use of the powerflex pro pta balloon catheter.The device will not be returned for evaluation.
Event or Problem Description
As reported, a 4mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 6 atmospheres (atm).An unknown device was used as a replacement and was inflated without issue.There were no reported injuries to the patient.This was during a procedure to treat a superficial femoral artery (sfa) lesion, a non-cordis.035 guidewire was inserted across the lesion prior to the use of the powerflex pro pta balloon catheter.Additional information was requested but was not provided.The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, a 4mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 6 atmospheres (atm).An unknown device was used as a replacement and was inflated without issue.There were no reported injuries to the patient.This was during a procedure to treat a superficial femoral artery (sfa) lesion, a non-cordis.035 guidewire was inserted across the lesion prior to the use of the powerflex pro pta balloon catheter.Additional information was requested but was not provided.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 82246856 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint " balloon burst at/below rbp¿ could not be evaluated.With the information provided, without the return of the device, and with no procedural films/images, the cause of the reported event could not be determined.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 device history record review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• 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: 21720648
• Report Number: 3007635982-2025-00066
• Device Sequence Number: 14451477
• Product Code: LIT
• UDI-Device Identifier: 20705032059142
• UDI-Public: (01)20705032059142(17)250331(10)82246856
• 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): 04/15/2025

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: 03/31/2025
• Device Catalogue Number: 4400404S
• Device Lot Number: 82246856
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• 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: GUIDEWIRE 35 RADIFOCUS, TERUMO.; UNKNOWN DEVICE.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic