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

Catalog Number	48005020X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when the 5mm 20cm saber percutaneous transluminal angioplasty (pta) balloon was attempted to be inflated it would not hold pressure.The procedure was completed using a second saber balloon.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 sterile packaging components, and no kinks or damages were noted prior to insertion.The device prepped normally and maintained negative pressure.However, when the balloon was inflated, it failed to hold pressure, indicating leakage during inflation.The intended procedure was a superficial femoral artery (sfa) intervention.The lesion showed moderate calcification, no vessel tortuosity, and 85% stenosis.The device was not used for a chronic total occlusion (cto).A 60/40 contrast-to-saline ratio was used, and the same indeflator had been used successfully with other devices during the procedure.No resistance or friction occurred while inserting the balloon through the rotating hemostatic valve, and no guide catheter was used¿the balloon was inserted through a contralateral 6fr sheath.The balloon catheter advanced smoothly through the vessel and crossed the lesion without difficulty.The catheter was not in an acute bend and did not kink during use.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 Manufacturer Narrative
As reported, when the 5mm 20cm saber percutaneous transluminal angioplasty (pta) balloon was attempted to be inflated it would not hold pressure.Leakage was observed during the product evaluation.The procedure was completed using a second saber balloon.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 sterile packaging components, and no kinks or damages were noted prior to insertion.The device prepped normally and maintained negative pressure.However, when the balloon was inflated, it failed to hold pressure, indicating leakage during inflation.The intended procedure was a superficial femoral artery (sfa) intervention.The lesion showed moderate calcification, no vessel tortuosity, and 85% stenosis.The device was not used for a chronic total occlusion (cto).A 60/40 contrast-to-saline ratio was used, and the same indeflator had been used successfully with other devices during the procedure.No resistance or friction occurred while inserting the balloon through the rotating hemostatic valve, and no guide catheter was used¿the balloon was inserted through a contralateral 6fr sheath.The balloon catheter advanced smoothly through the vessel and crossed the lesion without difficulty.The catheter was not in an acute bend and did not kink during use.The device will be returned for evaluation.A non-sterile unit of ¿saber 5mm20cm 150¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked for evaluation and underwent a thorough visual inspection, which revealed no damage upon receipt.The balloon was returned deflated and saturated with blood.No additional notable findings were observed.A functional test was performed.An inflator/deflator device was connected to the inflation port, and the balloon was pressurized in an attempt to reach the rated burst pressure.The balloon was unable to maintain pressure due to a leak.Subsequent inspection using a vision system identified a rupture on the balloon surface at the site of fluid leakage.The affected region exhibited a rupture with secondary scratch marks adjacent to the damaged border.This pattern of damage is consistent with contact from a sharp object or other mechanical insult.The scratch marks suggest that the same external mechanical factors likely contributed to the rupture observed on the returned device.The reported ¿balloon leakage during positive pressure¿ was observed during product evaluation.Inspection identified a rupture on the balloon surface accompanied by secondary scratch marks along the damaged border, findings consistent with external mechanical interaction.According to the event report, the procedure involved treatment of a vessel with moderate calcification and 85% stenosis.Based on the available information, the failure is most likely procedure-related and attributable to external mechanical interaction during clinical use.According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.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.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ based on the information available, there is no indication to suggest that the reported incident could be related to the design or manufacturing process of the units.No preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, when the 5mm 20cm saber percutaneous transluminal angioplasty (pta) balloon was attempted to be inflated it would not hold pressure.Leakage was observed during the product evaluation.The procedure was completed using a second saber balloon.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 sterile packaging components, and no kinks or damages were noted prior to insertion.The device prepped normally and maintained negative pressure.However, when the balloon was inflated, it failed to hold pressure, indicating leakage during inflation.The intended procedure was a superficial femoral artery (sfa) intervention.The lesion showed moderate calcification, no vessel tortuosity, and 85% stenosis.The device was not used for a chronic total occlusion (cto).A 60/40 contrast-to-saline ratio was used, and the same indeflator had been used successfully with other devices during the procedure.No resistance or friction occurred while inserting the balloon through the rotating hemostatic valve, and no guide catheter was used¿the balloon was inserted through a contralateral 6fr sheath.The balloon catheter advanced smoothly through the vessel and crossed the lesion without difficulty.The catheter was not in an acute bend and did not kink during use.The device will be returned for evaluation.

• Brand Name: SABER
• 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 ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 23456511
• Report Number: 3007635982-2025-00229
• Device Sequence Number: 9040050
• Product Code: LIT
• UDI-Device Identifier: 20705032069554
• UDI-Public: (01)20705032069554(17)280331(10)82334524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 48005020X
• Device Lot Number: 82334524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: UNKNOWN.
• Patient Sex: Unknown