MAUDE Adverse Event Report: CORDIS CORPORATION 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	04/01/2025
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.
Event or Problem Description
As reported, when passing the lesion, the 6mm 4cm saber radianz balloon ruptured.A balloon of another size was used to continue the procedure.The balloon ruptured below rbp.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu.The device prepped normally, maintaining negative pressure.The intended procedure was for an iliac lesion.The lesion was severely calcified.The vessel tortuosity was moderate.The percentage of stenosis was 100%.The device was used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve.There was no resistance or friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was a little difficulty crossing the lesion with the balloon catheter.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The device will be returned for evaluation.
Event or Problem Description
As reported, when passing the lesion, the 6mm 4cm saber radianz percutaneous transluminal angioplasty (pta) balloon ruptured.A balloon of another size was used to continue the procedure.The balloon ruptured below rbp.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu.The device prepped normally, maintaining negative pressure.The intended procedure was for an iliac lesion.The lesion was severely calcified.The vessel tortuosity was moderate.The percentage of stenosis was 100%.The device was used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve.There was no resistance or friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was a little difficulty crossing the lesion with the balloon catheter.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, when passing the lesion, the 6mm 4cm saber radianz percutaneous transluminal angioplasty (pta) balloon ruptured.A balloon of another size was used to continue the procedure.The balloon ruptured below rbp.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu.The device prepped normally, maintaining negative pressure.The intended procedure was for an iliac lesion.The lesion was severely calcified.The vessel tortuosity was moderate.The percentage of stenosis was 100%.The device was used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve.There was no resistance or friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was a little difficulty crossing the lesion with the balloon catheter.The catheter was never in an acute bend.The balloon catheter did not kink while being used.A non-sterile unit of ¿saberx radianz 6mm4cm 190¿ device 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 that the unit does not present any damages or anomalies.The balloon arrived deflated.No other outstanding details were observed.Functional test was performed.One inflator/deflator device was attached to the inflation port.Balloon inflation test was done by applying positive pressure using the inflator/deflator device with the purpose of reaching the rated burst pressure.The balloon was inflated as expected with the proper shape.No inflation difficulties or delays were observed, and the pressure remains steady.The reported event of ¿balloon burst at/below rbp¿ was not observed through analysis of the returned device since a functional test was performed and the balloon was inflated as expected with the proper shape.The cause of the reported issue could not be determined.Unspecified procedural, handling, and/or anatomical factors may have contributed to any difficulty experienced by the user.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 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.

• Brand Name: SABERX RADIANZ
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 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: 21919872
• Report Number: 3007635982-2025-00095
• Device Sequence Number: 8907623
• Product Code: LIT
• UDI-Device Identifier: 20705032081754
• UDI-Public: (01)20705032081754(17)270531(10)82313985
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Catalogue Number: R51006004L
• Device Lot Number: 82313985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Patient Sex: Unknown