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

Catalog Number	48002006X
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	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 2 mm 6 cm saber percutaneous transluminal angioplasty (pta) balloons that is faulty.The device was opened, and the tip had come off so it was not used inside the patient/during the procedure.There was no reported injury to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.E1: zip code: (b)(6).Phone #: (b)(6).
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 2mm 6cm saber percutaneous transluminal angioplasty (pta) balloons that is faulty.The device was opened, and the tip had come off so it was not used inside the patient / during the procedure.There was no reported injury to the patient.The device will be returned for evaluation.
Event or Problem Description
As reported, a 2mm 6cm saber percutaneous transluminal angioplasty (pta) balloons that is faulty.The device was opened, and the tip had come off so it was not used inside the patient / during the procedure.There was no reported injury to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 2mm 6cm saber percutaneous transluminal angioplasty (pta) balloons that is faulty.The device was opened, and the tip had come off, so it was not used inside the patient / during the procedure.There was no reported injury to the patient.Additional information was requested; however, it could not be obtained.The device was returned for analysis.A non-sterile ¿saber 2mm6cm 150¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that the distal tip presents a separated condition.The separated piece was not returned for analysis.The balloon was received without uninflated, and no other outstanding details were observed.The tip seal melt zone was verified, and dimensional analysis results were found within specification.Additionally, the id of the distal tip was measured and verified, dimensional analysis results were found within specification.The distal tip area was inspected using a vision system to obtain a magnified image.A side view of the leg balloon separation was inspected observing a clean cut.The distal tip and the inner lumen are fused.The edge of the fused distal tip presents an irregular torn separated pattern with elongations.The elongations and irregular torn pattern found on the material of the unit are commonly associated with separations caused by material tensile overload.It is assumed that the distal tip material was induced to an excessive sudden tension that exceeded the material yield strength prior to the separation.The reported ¿distal tip separated¿ was observed as the device was returned with the distal tip separated, the separated portion was not returned for analysis.Vision system magnification showed that the separation on the distal tip of the device presented evidence of elongations and irregular torn patterns on the edge of the distal tip.The elongations found on the material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the distal tip was induced to a tensile force that exceeded the material yield strength prior to the separation.Several factors are being considered, and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted.According to 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.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.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ the information available and product analysis suggest a possible manufacturing related cause for the reported event experienced by the customer.Further investigation to determine root cause required; therefore, an investigation has been initiated.

• 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: 21067167
• Report Number: 3007635982-2025-00001
• Device Sequence Number: 16963805
• Product Code: LIT
• UDI-Device Identifier: 20705032069912
• UDI-Public: (01)20705032069912(17)270228(10)82306771
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133843
• 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,Followup
• Report Date (Section B): 04/02/2025

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: 48002006X
• Device Lot Number: 82306771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2025; 03/11/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/14/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Patient Sex: Unknown