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

Catalog Number	R51006004L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product history record (phr) review of lot 82330520 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6 mm x 40 mm saber x-radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atm during pre-dilatation in a transradial intervention (tri) iliac case.A new device of the same size was opened and used, and the case was completed successfully.There was no reported patient injury.The device was used for pre-dilatation in an iliac case via tri approach.The product was stored and handled according to the instructions for use.No device damage was noted prior to opening the package.There was no difficulty removing the device from the sterile packaging or removing the protective balloon cover.An ipsilateral approach was used.The device maintained negative pressure during preparation.No anomalies were noted after the device was delivered to the lesion.The device was able to be removed easily and was removed intact in one piece.The same indeflator was used successfully with other devices.No anomalies were noted during inflation with positive pressure.There was no anomaly preventing device inflation.The indeflator gauge did not indicate a loss of pressure.The device was discarded at site.
Additional Manufacturer Narrative
As reported, a 6 mm x 40 mm saber x-radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atm during pre-dilatation in a transradial intervention (tri) iliac case.A new device of the same size was opened and used, and the case was completed successfully.There was no reported patient injury.The device was used for pre-dilatation in an iliac case via tri approach.The product was stored and handled according to the instructions for use.No device damage was noted prior to opening the package.There was no difficulty removing the device from the sterile packaging or removing the protective balloon cover.An ipsilateral approach was used.The device maintained negative pressure during preparation.No anomalies were noted after the device was delivered to the lesion.The device was able to be removed easily and was removed intact in one piece.The same indeflator was used successfully with other devices.No anomalies were noted during inflation with positive pressure.There was no anomaly preventing device inflation.The indeflator gauge did not indicate a loss of pressure.The device was discarded at the site.A product history record (phr) review of lot 82330520 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 verified as the device was not returned for analysis.The exact root cause of the event could not be determined.Based on the limited available information, procedural factors, vessel characteristics and handling of the device during the procedure likely contributed to the reported event.However, in the absence of product return, procedural images, or angiographic films, a definitive causal relationship between the device and the reported event cannot be established.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.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 (b)(4)% of the balloons (with a (b)(4)% 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.¿ 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: SABERX RADIANZ
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25; el coyol alajuela, costa rica ; 7863138372
• MDR Report Key: 24817977
• Report Number: 3007635982-2026-00054
• Device Sequence Number: 9686564
• Product Code: LIT
• UDI-Device Identifier: 20705032081754
• UDI-Public: (01)20705032081754(17)280131(10)82330520
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201377
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: R51006004L
• Device Lot Number: 82330520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: BT RADIANZ 110 CM; CROSSLEAD TRACKER 300 CM GUIDEWIRE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian