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

Catalog Number	48002530X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
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, an unknown guidewire fractured while using a 2.5mm x 30cm saber percutaneous transluminal angioplasty (pta) balloon catheter.There was no reported injury to the patient.Additional information was requested but was not provided.The device will be returned for evaluation.Addendum: the device was returned separated at the balloon portion.
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, an unknown guidewire fractured while using a 2.5mm x 30cm saber percutaneous transluminal angioplasty (pta) balloon catheter.There was no reported injury to the patient.Additional information was requested but was not provided.The device will be returned for evaluation.A non-sterile ¿saber 2.5mm30cm 150¿ was received inside a clear plastic bag for evaluation.Visual inspection confirmed that the balloon was separated approximately 21 cm from the distal tip, and the wire lumen was also separated.The separated areas of both components exhibited elongation at the edges, consistent with material tensile overload.Microscopic analysis identified twisting and elongation of the fractured regions, suggesting the device had been subjected to a tensile force that exceeded the material yield strength before failure.The distal tip was intact with no observed damage or anomalies.All dimensional and visual assessments were completed as received; no additional testing was performed to preserve device condition.No evidence was found to indicate that the observed separation condition was related to a manufacturing or design issue.The reported ¿balloon separated¿ was observed during the evaluation, and subsequent guidewire lumen separation was also noted.The exact cause of the event cannot be determined; however, procedural factors and vessel characteristics may have been contributing factors.With the limited amount of information provided, it is difficult to draw a clinical conclusion between the reported events and the condition of the device.It is clear the device was induced to events exceeding its material yield strength.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.¿ and ¿damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ 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.

• 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: 23321937
• Report Number: 3007635982-2025-00221
• Device Sequence Number: 9938063
• Product Code: LIT
• UDI-Device Identifier: 20705032069295
• UDI-Public: (01)20705032069295(17)271130(10)82326245
• 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): 10/31/2025

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: 48002530X
• Device Lot Number: 82326245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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 GUIDEWIRE.
• Patient Sex: Unknown