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

Catalog Number	48002525X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported, a 2.5mm 25cm.018 saber percutaneous transluminal angioplasty (pta) balloon did not fully inflate.It was removed and replaced with another balloon of the same size.After surgery, the operator tested inflation outside the body and observed leakage at one location.The surgery proceeded smoothly without other adverse effects.There was no reported injury to the patient.This occurred after standard procedure and wetting, and after insertion into the vessel.The device was used during a lower limb (below the knee) artery occlusion recanalization and balloon angioplasty.Below the knee dilatation.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing it from the hoop, protective balloon cover, or sterile packaging components.No kinks or damage were noted prior to insertion.The device was prepped per the ifu and maintained negative pressure normally.The lesion was moderately calcified with mild vessel tortuosity and 70%¿80% stenosis.The device was used for a chronic total occlusion (cto).No resistance or friction occurred while inserting the balloon through the guide catheter, though mild resistance was encountered while crossing the lesion.The catheter was not in an acute bend and did not kink during use.A 50:50 contrast-to-saline ratio was used.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 2.5mm 25cm.018 saber percutaneous transluminal angioplasty (pta) balloon did not fully inflate.It was removed and replaced with another balloon of the same size.After surgery, the operator tested inflation outside the body and observed leakage at one location.The surgery proceeded smoothly without other adverse effects.There was no reported injury to the patient.This occurred after standard procedure and wetting, and after insertion into the vessel.The device was used during a lower limb (below the knee) artery occlusion recanalization and balloon angioplasty.Below the knee dilatation.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing it from the hoop, protective balloon cover, or sterile packaging components.No kinks or damage were noted prior to insertion.The device was prepped per the ifu and maintained negative pressure normally.The lesion was moderately calcified with mild vessel tortuosity and 70%¿80% stenosis.The device was used for a chronic total occlusion (cto).No resistance or friction occurred while inserting the balloon through the guide catheter, though mild resistance was encountered while crossing the lesion.The catheter was not in an acute bend and did not kink during use.A 50:50 contrast-to-saline ratio was used.A non-sterile unit of catheter saber 2.5mm25cm 150 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, the balloon looks like it was not previously inflated.No other damage or anomalies were observed at naked eye on the returned device components.A functional analysis was performed at the pta catheter.An inflator/deflator was connected to the unit and when positive pressure was applied, a leakage could be noted at the distal section of the balloon.Amplified images of the area where the leakage was noted were taken, confirming that the distal end of the balloon was damaged.Evidence of elongation and irregular edges extending toward the interior of the plastic component material was observed.These characteristics are typically associated with the application of heat, which deforms the material beyond its elastic limit until failure occurs.The findings suggest that the material was exposed to a heated tool from the outside of the component.The reported ¿balloon leakage during positive pressure¿ was seen during the product evaluation.The leak was secondary to damage found on the distal portion of the balloon with characteristics that are typically associated with the application of heat.The exact source of the heat is unknown, but investigation findings suggest the damage may be procedurally or handling related because the device was prepped per the ifu and maintained negative pressure normally.This suggest the damages occurred after preparing the device.According to the device ifu, proper functioning of the catheter depends on its integrity, and care should be used when handling the catheter as damage may result from kinking, stretching, or forceful wiping.These instructions are consistent with the observed failure mode (leak) and support that handling factors may contribute to product performance issues.Based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, a 2.5mm 25cm.018 saber percutaneous transluminal angioplasty (pta) balloon did not fully inflate.It was removed and replaced with another balloon of the same size.After surgery, the operator tested inflation outside the body and observed leakage at one location.The surgery proceeded smoothly without other adverse effects.There was no reported injury to the patient.This occurred after standard procedure and wetting, and after insertion into the vessel.The device was used during a lower limb (below the knee) artery occlusion recanalization and balloon angioplasty.Below the knee dilatation.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing it from the hoop, protective balloon cover, or sterile packaging components.No kinks or damage were noted prior to insertion.The device was prepped per the ifu and maintained negative pressure normally.The lesion was moderately calcified with mild vessel tortuosity and 70%¿80% stenosis.The device was used for a chronic total occlusion (cto).No resistance or friction occurred while inserting the balloon through the guide catheter, though mild resistance was encountered while crossing the lesion.The catheter was not in an acute bend and did not kink during use.A 50:50 contrast-to-saline ratio was used.The device will be returned for evaluation.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US CORP; 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: 23036974
• Report Number: 3007635982-2025-00196
• Device Sequence Number: 15755027
• Product Code: LIT
• UDI-Device Identifier: 20705032069080
• UDI-Public: (01)20705032069080(17)280331(10)82333632
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 48002525X
• Device Lot Number: 82333632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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: BOSTON SCIENTIFIC V18 GUIDEWIRE.; COOK CROSSOVER SHEATH.
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 86 KG