MAUDE Adverse Event Report: CORDIS US CORP. SABERX014; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	47512015M
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 1.25 × 15mm 150cm saber x.014 percutaneous transluminal angioplasty (pta) dilatation catheter ruptured during inflation at the lesion.Another balloon was used and the procedure was continued.There was no reported patient injury.The device used in the endovascular therapy (evt) procedure.The intended procedure was endovascular therapy (evt).The product was stored and handled according to the instructions for use (ifu), with no damage noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging, including the protective balloon cover and other components.A contralateral approach was used.The target vessel had no tortuosity or acute angles, was 100% stenosed, and was moderately bifurcated.Access vessel characteristics showed no calcification, no tortuosity, 10% stenosis, no acute angles, and moderate bifurcation.The device maintained negative pressure during preparation, was not placed into an acute bend, and did not kink during the procedure.No anomalies were noted after delivery to the lesion.The device was easily removed intact from the patient.The contrast-to-saline ratio used was 50:50.The same indeflator had not been used successfully with other devices.No anomalies were noted during inflation, including no issues preventing inflation, and no loss of pressure was indicated on the indeflator gauge.The device was inflated to 8 atmospheres and pressure was maintained for 2¿3 seconds.No resistance was encountered while withdrawing the device, which was discarded at site along with other devices.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the balloon of a 1.25 × 15mm 150cm saber x.014 percutaneous transluminal angioplasty (pta) dilatation catheter ruptured during inflation at the lesion.Another balloon was used and the procedure was continued.There was no reported patient injury.The device used in the endovascular therapy (evt) procedure.The intended procedure was endovascular therapy (evt).The product was stored and handled according to the instructions for use (ifu), with no damage noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging, including the protective balloon cover and other components.A contralateral approach was used.The target vessel had no tortuosity or acute angles, was 100% stenosed, and was moderately bifurcated.Access vessel characteristics showed no calcification, no tortuosity, 10% stenosis, no acute angles, and moderate bifurcation.The device maintained negative pressure during preparation, was not placed into an acute bend, and did not kink during the procedure.No anomalies were noted after delivery to the lesion.The device was easily removed intact from the patient.The contrast-to-saline ratio used was 50:50.The same indeflator had not been used successfully with other devices.No anomalies were noted during inflation, including no issues preventing inflation, and no loss of pressure was indicated on the indeflator gauge.The device was inflated to 8 atmospheres and pressure was maintained for 2¿3 seconds.No resistance was encountered while withdrawing the device, which was discarded at site along with other devices.The product was not returned for analysis.A product history record (phr) review of lot 2506199594 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon- burst¿ could not be verified as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of 100% stenosis with moderate bifucation 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
Device was discarded at site.

• Brand Name: SABERX014
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 15th building smes venture park songshan lake hi-tech zone; dongguan, guangdong ; 7863138372
• MDR Report Key: 23785606
• Report Number: 1016427-2025-00093
• Device Sequence Number: 10448217
• Product Code: LIT
• UDI-Device Identifier: 20705032089811
• UDI-Public: (01)20705032089811(17)280731(10)2506199594
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221832
• 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): 01/19/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 47512015M
• Device Lot Number: 2506199594
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2025
• 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: UNK.
• Patient Age: 70 YR
• Patient Sex: Male