MAUDE Adverse Event Report: CORDIS US. CORP SABERX RADIANZ; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	R51003004L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
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, after delivering a 3mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter to the lesion, the balloon ruptured during its initial inflation to 8 atmospheres (atm).A new saberx pta balloon catheter was used as a replacement to complete the procedure.There were no reported injuries to the patient.The target vessel was the superficial femoral artery (sfa), with mild calcification, mild tortuosity, and 90% stenosis.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, after delivering a 3mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter to the lesion, the balloon ruptured during its initial inflation to 8 atmospheres (atm).A new saberx pta balloon catheter was used as a replacement to complete the procedure.There were no reported injuries to the patient.The target vessel was the superficial femoral artery (sfa), with mild calcification, mild tortuosity, and 90% stenosis.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The product was not returned for analysis.A review of the manufacturing documentation associated with lot: 82266240 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 confirmed.The exact cause could not be determined.The reported calcification, tortuosity, and stenosis of the superficial femoral artery may have contributed to the reported event; it is likely to have caused damage to the balloon material that led to its rupture.According to the warnings in the safety information in the instructions for use, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ 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: SABERX RADIANZ
• 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: 21574742
• Report Number: 3007635982-2025-00059
• Device Sequence Number: 18250398
• Product Code: LIT
• UDI-Device Identifier: 20705032081815
• UDI-Public: (01)20705032081815(17)251130(10)82266240
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/21/2025

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: 11/30/2025
• Device Catalogue Number: R51003004L
• Device Lot Number: 82266240
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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: SABERX PTA BALLOON CATHETER.
• Patient Sex: Unknown