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

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a saberx radianz 6mm4cm 190 percutaneous transluminal angioplasty (pta) ruptured during inflation at the lesion site.Another balloon was used to continue the procedure.There was no reported patient injury.The product was reported to have been stored properly per the instructions for use (ifu), and there were no difficulties removing it from the hoop, protective balloon cover, stylet, or sterile packaging components.No kinks or damages were observed prior to insertion, and the device was prepped according to the ifu and maintained negative pressure normally.The intended procedure involved the iliac artery with a left external iliac artery target, where the vessel exhibited severe calcification, moderate tortuosity, 100% stenosis, a moderate acute angle, and moderate bifurcation.Access vessel characteristics included moderate tortuosity, a moderate acute angle, and moderate bifurcation.The device was used for a chronic total occlusion, and the balloon ruptured at approximately 6 atmospheres.The rupture did not occur within a stent.Iopamiron contrast media was used at a half contrast-to-saline ratio.The same indeflator had been used successfully with other devices.No resistance or friction was encountered through the rotating hemostatic valve or guide catheter, and there was no difficulty advancing the balloon, crossing the lesion, or navigating bends.The catheter did not kink and was removed intact.The procedure was completed using a non-cordis balloon.The device will not be returned for evaluation as it was discarded.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, the balloon of a saberx radianz 6mm4cm 190 percutaneous transluminal angioplasty (pta) ruptured during inflation at the lesion site.Another balloon was used to continue the procedure.There was no reported patient injury.The product was reported to have been stored properly per the instructions for use (ifu), and there were no difficulties removing it from the hoop, protective balloon cover, stylet, or sterile packaging components.No kinks or damages were observed prior to insertion, and the device was prepped according to the ifu and maintained negative pressure normally.The intended procedure involved the iliac artery with a left external iliac artery target, where the vessel exhibited severe calcification, moderate tortuosity, 100% stenosis, a moderate acute angle, and moderate bifurcation.Access vessel characteristics included moderate tortuosity, a moderate acute angle, and moderate bifurcation.The device was used for a chronic total occlusion, and the balloon ruptured at approximately 6 atmospheres.The rupture did not occur within a stent.Iopamiron contrast media was used at a half contrast-to-saline ratio.The same indeflator had been used successfully with other devices.No resistance or friction was encountered through the rotating hemostatic valve or guide catheter, and there was no difficulty advancing the balloon, crossing the lesion, or navigating bends.The catheter did not kink and was removed intact.The procedure was completed using a non-cordis balloon.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 82317880 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.Therefore, the exact root cause of the event could not be determined.Based on the available information, the challenging vessel anatomy, including severe calcification, moderate tortuosity, and 100% stenosis, may have contributed to increased mechanical stress on the balloon during lesion crossing and inflation.While damage to the balloon material may have occurred either during advancement through the lesion or during inflation, this cannot be verified.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 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.¿ 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 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: 24132347
• Report Number: 3007635982-2026-00012
• Device Sequence Number: 17506689
• Product Code: LIT
• UDI-Device Identifier: 20705032081754
• UDI-Public: (01)20705032081754(17)270731(10)82317880
• 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): 02/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: R51006004L
• Device Lot Number: 82317880
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2024
• 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 BALLOON.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 54 KG