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

Catalog Number	48006030X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
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.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was an air leakage during the use of a 6mm x 30cm saber percutaneous transluminal angioplasty (pta) balloon catheter.There were no reported injuries to the patient.Additional information was requested but was not provided.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, there was an air leakage due to a burst condition during the use of a 6mm x 30cm saber percutaneous transluminal angioplasty (pta) balloon catheter.An unknown balloon was used as a replacement device.There were no reported injuries to the patient.The device was used inside the patient, targeting the superficial femoral artery (sfa), which had moderate vessel characteristics.The device was stored and prepped according to the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components, and no observable damage was noted on the device.There was no difficulty connecting the device to the luer hub.Additional details were requested but were unknown.The device was returned for evaluation.A non-sterile ¿saber 6mm30cm 150¿ device was received for analysis, coiled inside a clear plastic bag.The device was unpacked and subjected to evaluation.A visual inspection revealed an axial burst on the balloon, with no other notable observations.Functional testing was not performed due to the damaged condition of the unit as received.Using a vision system, the balloon was further examined, and a rupture was observed on the surface at the point of water leakage.The balloon surface showed clear evidence of rupture, with elongations and secondary scratch marks located near the damaged border area.This type of damage is typically associated with contact between the material and a sharp object or other mechanical forces.It is highly likely that the same factors responsible for the scratch marks and elongations contributed to the rupture observed on the device.The characteristics of the damage suggest that the material near the affected area was compromised by an external sharp object.The reported ¿balloon burst¿ was observed during device analysis, where an axial rupture was identified along the length of the balloon material.The leakage was most likely attributable to localized mechanical damage, evidenced by rupture features, elongations, and secondary scratch marks near the affected area.While the precise root cause cannot be definitively established, the observed damage characteristics are consistent with contact from a sharp object or external force during clinical use.Additionally, the presence of moderate vessel characteristics at the treatment site may have contributed to the mechanical stress on the balloon, further compromising the structural integrity of the material.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.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.¿ the available information and product evaluation do not indicate a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action is required.
Event or Problem Description
As reported, there was an air leakage due to a burst condition during the use of a 6mm x 30cm saber percutaneous transluminal angioplasty (pta) balloon catheter.An unknown balloon was used as a replacement device.There were no reported injuries to the patient.The device was used inside the patient, targeting the superficial femoral artery (sfa), which had moderate vessel characteristics.The device was stored and prepped according to the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components, and no observable damage was noted on the device.There was no difficulty connecting the device to the luer hub.Additional details were requested but were unknown.The device will be returned for evaluation.Addendum: product evaluation revealed a rupture on the balloon of the saber pta balloon catheter.

• 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: 22642602
• Report Number: 3007635982-2025-00165
• Device Sequence Number: 8632728
• Product Code: LIT
• UDI-Device Identifier: 20705032068182
• UDI-Public: (01)20705032068182(17)251130(10)82250986
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 48006030X
• Device Lot Number: 82250986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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