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

Catalog Number	48002515X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 2.5mm 15cm saber percutaneous transluminal angioplasty (pta) balloon body was damaged.This resulted in air leakage during inflation.The issue occurred during balloon inflation in the anterior tibial artery.The procedure was completed by replacing it with a new saber 2.5*150 device.There was no reported injury to the patient.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The vessel exhibited mild tortuosity without calcification, and the stenosis was approximately 50%.There was no damage to the packaging, and no additional anomalies were noted.The device was returned for evaluation.A non-sterile ¿saber 2.5mm15cm 150¿ was received for analysis, coiled inside a clear plastic bag.The device was unpacked for evaluation, and a thorough visual inspection revealed no damage or anomalies.The balloon was received in a deflated condition, and no additional notable observations were made.A functional test was conducted.An inflator/deflator device was attached to the inflation port, and the balloon was inflated by applying positive pressure to reach the rated burst pressure.However, the inflation pressure could not be maintained due to a leak observed in the balloon.Further inspection using a vision system revealed a rupture on the balloon surface at the site of the water leak.The ruptured area exhibited secondary scratch marks near the damaged border.This type of damage is typically consistent with interaction between the balloon material and a sharp object or mechanical force.It is likely that the same factors responsible for the scratch marks also contributed to the rupture.The evidence suggests that the material near the damaged area was compromised by contact with a sharp external object.The reported ¿balloon leakage¿ 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 mild tortuosity and approximately 50% stenosis.Although these vessel characteristics are not expected to generate excessive mechanical stress, mild tortuosity can introduce additional friction or bending forces on the device during advancement or inflation.Such procedural conditions, combined with possible contact against a guidewire, introducer sheath component, or a focal irregularity within the vessel lumen, may have contributed to the localized surface compromise and rupture observed.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, the 2.5mm 15cm saber percutaneous transluminal angioplasty (pta) balloon body was damaged.This resulted in air leakage during inflation.The issue occurred during balloon inflation in the anterior tibial artery.The procedure was completed by replacing with a new saber 2.5*150 device.There was no reported injury to the patient.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The vessel exhibited mild tortuosity without calcification, and the stenosis was approximately 50%.There was no damage to the packaging, and no additional anomalies were noted.The device will not 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 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 CR201-02 ; CS CR20102 ; 7863138372
• MDR Report Key: 23362347
• Report Number: 3007635982-2025-00225
• Device Sequence Number: 15671472
• Product Code: LIT
• UDI-Device Identifier: 20705032069066
• UDI-Public: 20705032069066
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971010
• 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): 10/22/2025

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: 48002515X
• Device Lot Number: 82294959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• 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: 10/17/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: 0.018-INCH BOSTON SCIENTIFIC GUIDEWIRE; 0.035-INCH TERUMO GUIDEWIRE; 5 F ANGIOGRAPHIC CATHETER; 6 F COOK CROSSOVER SHEATH
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 62 KG