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

Catalog Number	48006030X
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when advancing a 6mm x 30mm saber.018 percutaneous transluminal angioplasty (pta) balloon catheter over an unknown guidewire, the physician noticed a tear halfway down on the catheter shaft.The device was removed from the guidewire before being inserted into the patient, and a new unknown balloon was opened to finish the procedure successfully.There were no reported injuries to the patient.This was during a procedure to treat in-stent restenosis with the leg.The device was properly stored and opened in the sterile field and was prepped prior to being advanced over the unknown guidewire.The user was trained to the device.Additional information was requested but was not provided.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 information is pending and will be submitted within 30 days upon receipt.
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, when advancing a 6mm x 30mm saber.018 percutaneous transluminal angioplasty (pta) balloon catheter over an unknown guidewire, the physician noticed a tear halfway down on the catheter shaft.The device was removed from the guidewire before being inserted into the patient, and a new unknown balloon was opened to finish the procedure successfully.There were no reported injuries to the patient.This was during a procedure to treat in-stent restenosis with the leg.The device was properly stored and opened in the sterile field and was prepped prior to being advanced over the unknown guidewire.The user was trained to the device.Additional information was requested but was not provided.The device was returned for evaluation.One non-sterile unit of a saber 6mm x 30cm 150 was received inside a clear plastic bag.The device was unpacked to proceed with product evaluation.Upon visual inspection, the device was received coiled, and the balloon was fully deflated.A close visual inspection of the balloon was performed, and no anomalies were observed.The remaining components of the unit were also inspected, with no damage or irregularities noted.Additionally, no signs of frayed/split/torn were observed along the body shaft.An inflation/deflation test was performed as part of the device failure investigation.The balloon was successfully inflated and deflated as intended.Following testing, the device was inspected for any damages or anomalies that may have contributed to the reported failure; however, no damages or anomalies were observed on the returned device.The reported ¿body/shaft - frayed/split/torn¿ was not observed during analysis of the returned device.The exact cause of the reported event could not be determined as the device was intact and passed functional analysis.The balloon was inflated/deflated with no burst or leaks noted and without any issues to the balloon or along the body shaft of the catheter.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.It is unclear why the reported event does not match the returned device for analysis.According to the warnings in the safety information in the instructions for use ¿the balloon dimensions are printed on the product label.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.¿ 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: 24607944
• Report Number: 3007635982-2026-00037
• Device Sequence Number: 10224928
• Product Code: LIT
• UDI-Device Identifier: 20705032068182
• UDI-Public: (01)20705032068182(17)271031(10)82324583
• 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): 04/16/2026

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: 48006030X
• Device Lot Number: 82324583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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: UNKNOWN BALLOON.
• Patient Sex: Unknown