MAUDE Adverse Event Report: Cordis US. Corp SABERX RADIANZ; Catheter, Angioplasty, Peripheral, Transluminal

Catalog Number	R51007004L
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a 7mm x 4cm 190 cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter was unable to deflate after inflation in the body despite the application of negative pressure.Pressure could still be applied while the balloon remained inflated.Negative pressure was continuously applied, and after the pressure dropped slightly, the device was pulled back to the aorta and intentionally ruptured using the back end of the guidewire to complete the procedure.There was no reported patient injury.There was no problem during device preparation.There was no difficulty removing the protective balloon cover or any sterile packaging components, and a contralateral approach was not used.The device was used during pcps removal.The target vessel was the femoral vein.At the target site, the vessel characteristics included no calcification, moderate tortuosity, 50% stenosis, a moderate acute angle, and moderate bifurcation.The vessel characteristics for accessing the target site included no calcification, no tortuosity, no stenosis, no acute angle, and moderate bifurcation.The device was not placed into an acute bend at any point during the procedure, successfully crossed the lesion, and did not kink at any time.No anomalies were noted after the device was delivered to the lesion.The physician requested an investigation into why pressure could be applied but negative pressure could not achieve deflation and requested evaluation of the lumen because the device was intentionally ruptured.The device will be returned for evaluation.
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.Additional information is pending and will be submitted within 30 days upon receipt.

• 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 CR 2 -01 0 ; +011(786)3138372
• MDR Report Key: 50172334
• Report Number: 3007635982-2026-00128
• Device Sequence Number: 9860185
• Product Code: LIT
• UDI-Device Identifier: 20705032081808
• UDI-Public: (01)20705032081808(17)290131(10)82363995
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: R51007004L
• Device Lot Number: 82363995
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 125 LB