MAUDE Adverse Event Report: CORDIS CORPORATION 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	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during inflation of a 1.25mm x 15mm saberx.014 percutaneous transluminal angioplasty (pta) balloon catheter, calcification was encountered in the superficial femoral artery (sfa) lesion and the balloon ruptured.The deice was removed and a 1.5mm x 40m non-cordis balloon catheter was used to continue the procedure.There were no reported injuries to the patient.The device was stored and prepped according to the instructions for use (ifu), with no difficulty encountered in removing sterile packaging components or the protective balloon cover.Negative pressure was maintained during preparation.The target vessel exhibited no tortuosity and 100% stenosis.The device was not placed in an acute bend during the procedure and was unable to cross the lesion.The device did not kink.It was removed easily and intact in one piece from the patient.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during inflation of a 1.25mm x 15mm saberx.014 percutaneous transluminal angioplasty (pta) balloon catheter, calcification was encountered in the superficial femoral artery (sfa) lesion and the balloon ruptured.The deice was removed and a 1.5mm x 40m non-cordis balloon catheter was used to continue the procedure.There were no reported injuries to the patient.The device was stored and prepped according to the instructions for use (ifu), with no difficulty encountered in removing sterile packaging components or the protective balloon cover.Negative pressure was maintained during preparation.The target vessel exhibited no tortuosity and 100% stenosis.The device was not placed in an acute bend during the procedure and was unable to cross the lesion.The device did not kink.It was removed easily and intact in one piece from the patient.The device will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, during inflation of a 1.25mm x 15mm saberx.014 percutaneous transluminal angioplasty (pta) balloon catheter, calcification was encountered in the superficial femoral artery (sfa) lesion and the balloon ruptured.The device was removed and a 1.5mm x 40m non-cordis balloon catheter was used to continue the procedure.There were no reported injuries to the patient.The device was stored and prepped according to the instructions for use (ifu), with no difficulty encountered in removing sterile packaging components or the protective balloon cover.Negative pressure was maintained during preparation.The target vessel exhibited no tortuosity and 100% stenosis.The device was not placed in an acute bend during the procedure and was unable to cross the lesion.The device did not kink.It was removed easily and intact in one piece from the patient.The product was not returned for analysis.A product history record (phr) review of lot 2508020985 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 confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of calcification with 100% 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.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.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.

• 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 ; 7863138372
• MDR Report Key: 23881345
• Report Number: 1016427-2025-00096
• Device Sequence Number: 4706415
• Product Code: LIT
• UDI-Device Identifier: 20705032089811
• UDI-Public: (01)20705032089811(17)280731(10)2508020985
• 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): 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): 02/27/2026

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
• Device Catalogue Number: 47512015M
• Device Lot Number: 2508020985
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/27/2026
• 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: JADE2 1.5MM×40MM.
• Patient Age: 70 YR
• Patient Sex: Male