MAUDE Adverse Event Report: CORDIS CORPORATION SABERX014; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	47525040M
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a 2.5 x 40.014 saberx percutaneous transluminal angioplasty (pta) balloon was used for pre-pta in below the knee (bk) treatment.The balloon ruptured at eight atm and was replaced with a backup.014 saberx, completing the procedure successfully.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 it from the hoop, the protective balloon cover, or any of the sterile packaging components.No kinks or damages were observed prior to insertion.The device was prepped per the ifu and maintained negative pressure normally.The intended procedure was an endovascular therapy (evt).The lesion showed 50% calcification, no vessel tortuosity, and 95% stenosis.The device was not used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The balloon catheter advanced smoothly through the vessel and crossed the lesion without difficulty.The catheter was positioned in an acute bend during the procedure but did not kink while being used.A 1:1 contrast-to-saline ratio was applied.The device was discarded.The product was not returned for analysis.A product history record (phr) review of lot 2501084489 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with 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.Vessel characteristics of calcification with 95% stenosis may have contributed to the reported event, as damage to balloon material may have occurred during crossing or upon inflation.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use, which are not intended to mitigate risk, ¿carefully inspect the catheter prior to use to verify that the catheter has not been damaged and that its size, shape and condition are suitable for the procedure for which it is to be used.Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution via the guide-wire access port prior to use.Never attempt to move the guide wire when the balloon is inflated.Do not advance the catheter against significant resistance.The cause of resistance should be determined via fluoroscopy.Inflation in excess of the rated burst pressure may cause the balloon to rupture.Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline solution).It has been shown that a 25/75% contrast / saline ratio has yielded faster balloon inflation / deflation times.Never use air or other gaseous medium to inflate the balloon.If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/ introducer sheath as a single unit.Do not continue to use the balloon catheter if the shaft has been bent or kinked.¿ 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.
Event or Problem Description
As reported, a 2.5 x 40.014 saberx percutaneous transluminal angioplasty (pta) balloon was used for pre-pta in below the knee (bk) treatment.The balloon ruptured at 8 atm and was replaced with a backup.014 saberx, completing the procedure successfully.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 it from the hoop, the protective balloon cover, or any of the sterile packaging components.No kinks or damages were observed prior to insertion.The device was prepped per the ifu and maintained negative pressure normally.The intended procedure was an endovascular therapy (evt).The lesion showed 50% calcification, no vessel tortuosity, and 95% stenosis.The device was not used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The balloon catheter advanced smoothly through the vessel and crossed the lesion without difficulty.The catheter was positioned in an acute bend during the procedure but did not kink while being used.A 1:1 contrast-to-saline ratio was applied.The device was discarded.

• Brand Name: SABERX014
• 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 ; 15th building smes venture park songshan lake hi-tech zone; dongguan, guangdong 52380-8 ; CH 523808 ; 7863138372
• MDR Report Key: 23539046
• Report Number: 1016427-2025-00087
• Device Sequence Number: 9448820
• Product Code: LIT
• UDI-Device Identifier: 20705032088920
• UDI-Public: (01)20705032088920(17)280229(10)2501084489
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: 47525040M
• Device Lot Number: 2501084489
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2025
• 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: 4.5FR PARENT SHEATH USED.
• Patient Sex: Unknown