MAUDE Adverse Event Report: CORDIS CORPORATION SABERX RADIANZ; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	R51005006L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
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, during the treatment of the superficial femoral artery (sfa), the 5mm 6cm saberx radianz percutaneous transluminal angioplasty (pta) balloon ruptured.The balloon ruptured within nominal pressure.The procedure was continued using a different size saberx radianz.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, protective balloon cover, 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 according to the ifu and maintained negative pressure during preparation.The intended procedure was the superficial femoral artery (sfa), which had a chronic total occlusion (cto).The lesion had severe calcification, moderate vessel tortuosity, and 100% stenosis.There was no resistance or friction during insertion through the rotating hemostatic valve or guide catheter.There were no difficulties advancing the balloon catheter through the vessel or while crossing the lesion.The catheter was never in an acute bend and did not kink during use.The device was discarded after use.
Additional Manufacturer Narrative
As reported, during the treatment of the superficial femoral artery (sfa), the 5mm 6cm saberx radianz percutaneous transluminal angioplasty (pta) balloon ruptured.The balloon ruptured within nominal pressure.The procedure was continued using a different size saberx radianz.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, protective balloon cover, 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 according to the ifu and maintained negative pressure during preparation.The intended procedure was the superficial femoral artery (sfa), which had a chronic total occlusion (cto).The lesion had severe calcification, moderate vessel tortuosity, and 100% stenosis.There was no resistance or friction during insertion through the rotating hemostatic valve or guide catheter.There were no difficulties advancing the balloon catheter through the vessel or while crossing the lesion.The catheter was never in an acute bend and did not kink during use.The product was not returned for analysis.A review of the manufacturing documentation associated with lot: 82276475 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.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.Procedural factors are likely since it was reported that the lesion was severely calcified, moderately tortuous, and had 100% stenosis/cto.This may have caused damage to the balloon surface 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.
Event or Problem Description
As reported, during the treatment of the superficial femoral artery (sfa), the 5mm 6cm saberx radianz percutaneous transluminal angioplasty (pta) balloon ruptured.The balloon ruptured within nominal pressure.The procedure was continued using a different size saberx radianz.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, protective balloon cover, 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 according to the ifu and maintained negative pressure during preparation.The intended procedure was the superficial femoral artery (sfa), which had a chronic total occlusion (cto).The lesion had severe calcification, moderate vessel tortuosity, and 100% stenosis.There was no resistance or friction during insertion through the rotating hemostatic valve or guide catheter.There were no difficulties advancing the balloon catheter through the vessel or while crossing the lesion.The catheter was never in an acute bend and did not kink during use.The device was discarded after use.

• Brand Name: SABERX RADIANZ
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; santa clara 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: 21540462
• Report Number: 3007635982-2025-00050
• Device Sequence Number: 7018663
• Product Code: LIT
• UDI-Device Identifier: 20705032081242
• UDI-Public: (01)20705032081242(17)260228(10)82276475
• 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): 03/25/2025

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: 02/28/2026
• Device Catalogue Number: R51005006L
• Device Lot Number: 82276475
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• 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: 2025.02.10.
• Patient Sex: Unknown