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

Catalog Number	48003015X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
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, the balloon of a 3mm x 15cm saber percutaneous transluminal angioplasty (pta) balloon catheter was found to have an air leak during negative preparation.The device was not used inside the patient, and a non-cordis balloon was used to complete the procedure.There were no reported adverse events or injuries to the patient.The intended procedure was peripheral artery angioplasty of the lower limb.The device was stored and prepared according to the instructions for use (ifu).There were no difficulties removing the sterile packaging components or the protective balloon cover, and the cover did not twist or rotate during removal.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the balloon of a 3mm x 15cm saber percutaneous transluminal angioplasty (pta) balloon catheter was found to have an air leak during negative preparation.The device was not used inside the patient, and a non-cordis balloon was used to complete the procedure.There were no reported adverse events or injuries to the patient.The intended procedure was peripheral artery angioplasty of the lower limb.The device was stored and prepared according to the instructions for use (ifu).There were no difficulties removing the sterile packaging components or the protective balloon cover, and the cover did not twist or rotate during removal.The device will be returned for evaluation.A non-sterile ¿saber 3mm15cm 150¿ device was received for analysis coiled inside of a clear plastic bag.The device was unpacked to initiate product evaluation.A comprehensive visual inspection confirmed that the balloon was received in a deflated state without manufacturing pleats; no additional abnormalities were identified.Functional testing was conducted by attaching an inflator/deflator device to the inflation port.The balloon was inflated using positive pressure to approach rated burst pressure.Inflation occurred as expected, with no delays, resistance, or instability observed, and pressure remained steady throughout the test.Post-inflation inspection did not reveal any defects or irregularities.With the balloon deflated, negative pressure was applied and no leaking condition or other anomalies were observed.The negative pressure remains steady.Based on the evaluation, there is no evidence to indicate that the reported event is attributable to manufacturing or design-related causes.Accordingly, no corrective or preventive actions are warranted at this time.The reported ¿balloon leakage during negative prep¿ was not verified during evaluation as the returned device functioned within specifications.No leaks, bursts, or performance issues were identified during analysis.Based on the available information and the absence of observed anomalies, the exact cause of the reported event could not be determined.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted to the device.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.¿ neither the information available nor product evaluation 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: 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: 24223277
• Report Number: 3007635982-2026-00020
• Device Sequence Number: 18224344
• Product Code: LIT
• UDI-Device Identifier: 20705032069103
• UDI-Public: (01)20705032069103(17)270930(10)82321311
• 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): 04/01/2026

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: 48003015X
• Device Lot Number: 82321311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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: NON-CORDIS BALLOON.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 72 KG