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

Catalog Number	R51003004L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 3mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation to 8 atmospheres (atm).There were no reported injuries to the patient.The target vessel was the iliac.The target site vessel characteristics were moderate calcification, mild tortuosity, and 90% stenosis.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The device was able to be delivered to the lesion.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of a 3mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation to 8 atmospheres (atm).There were no reported injuries to the patient.The target vessel was the iliac.The target site vessel characteristics were moderate calcification, mild tortuosity, and 90% stenosis.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The device was able to be delivered to the lesion.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 82246519 presented no issues during the manufacturing process that can be related to the reported event.The reported ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.The reported moderate calcification of the common iliac artery may have contributed to the reported event; it is likely to have caused damage to the balloon material that led to its rupture.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device and the reported event.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.Do not exceed the rated burst pressure recommended on the label.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.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.

• 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 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 21458095
• Report Number: 3007635982-2025-00040
• Device Sequence Number: 7591941
• Product Code: LIT
• UDI-Device Identifier: 20705032081815
• UDI-Public: (01)20705032081815(17)250228(10)82246519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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: 02/28/2025
• Device Catalogue Number: R51003004L
• Device Lot Number: 82246519
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2022
• 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