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

Catalog Number	48004010X
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, after crossing the lesion with a non-cordis guidewire, there was resistance in the guidewire lumen of 4mm x 10cm saber percutaneous transluminal angioplasty (pta) balloon catheter and the device could not be pushed to the lesion site.There was no difficulty removing the device from the patient and no separation occurred.A new 4mm x 15mm saber pta balloon catheter was used to complete the procedure.There were no reported injuries to the patient or signs of infectious disease.This was during a procedure to dilate a 60% stenosed superficial femoral artery (sfa) lesion.Which had moderate calcification and mild tortuosity.The device was stored and prepped per the instructions for use (ifu) and there were no difficulties removing the sterile packaging components.The guidewire resistance was not caused by a possible injectable material.The device was returned for evaluation.A non-sterile ¿saber 5mm20cm 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 and found to have no damages or anomalies.The balloon was received deflated.Functional testing was performed.The flushing process was applied to the returned unit.A syringe filled with water was attached to the guidewire lumen port, and the device was flushed.During this process, water exited from the distal tip of the unit.Next, a lab sample guidewire of the appropriate size was inserted into the distal tip to check for any resistance, friction, or obstruction.The guidewire traveled approximately 55 cm inside the wire lumen before encountering an obstruction and could not advance further.Lastly, an inflator/deflator device was attached to the inflation port.Positive pressure was applied with the purpose of reaching the rated burst pressure.The balloon was inflated as expected and the pressure remained steady.The obstruction area was inspected using a vision system, revealing a 10 mm obstruction inside the wire lumen.Ftir analysis was conducted to determine the chemical composition of the white matter in the obstruction.The results identified the foreign material as polyethylene, based on the infrared spectroscopy (ir) spectrum¿s main peaks.This material is expected to be found on the inner surface of the guide wire lumen.The reported ¿guidewire lumen resistance/friction¿ was confirmed to be a ¿guidewire lumen ¿ obstructed¿ after device analysis.However, the exact cause cannot be determined.During analysis the material noted inside the guidewire lumen was noted to be polyethylene, the same material that is comprised of the guidewire lumen inner body.It is likely the accordioned piece was sheared off at some point due to the interaction of the lining with a sharp object.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 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.¿ based on the information available, product analysis suggests that the event experienced by the customer needs further investigation to determine root cause.Therefore, an investigation has been initiated.
Event or Problem Description
As reported, after crossing the lesion with a non-cordis guidewire, there was resistance in the guidewire lumen of 4mm x 10cm saber percutaneous transluminal angioplasty (pta) balloon catheter and the device could not be pushed to the lesion site.There was no difficulty removing the device from the patient and no separation occurred.A new 4mm x 15mm saber pta balloon catheter was used to complete the procedure.There were no reported injuries to the patient or signs of infectious disease.This was during a procedure to dilate a 60% stenosed superficial femoral artery (sfa) lesion.Which had moderate calcification and mild tortuosity.The device was stored and prepped per the instructions for use (ifu) and there were no difficulties removing the sterile packaging components.The guidewire resistance was not caused by a possible injectable material.The device will be returned for evaluation.Addendum: product evaluation revealed an obstruction within the saber pta balloon catheter caused by a detached piece of the inner guidewire lumen.

• 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 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 20130122
• Report Number: 3007635982-2024-00222
• Device Sequence Number: 15324076
• Product Code: LIT
• UDI-Device Identifier: 20705032069479
• UDI-Public: (01)20705032069479(17)250131(10)82239700
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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: 01/31/2025
• Device Catalogue Number: 48004010X
• Device Lot Number: 82239700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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: 4MM X 15MM SABER PTA BALLOON CATHETER.; BOCO V18 GUIDE WIRE.; CORDIS AVANTI+ 5F.; TERUMO BLACK LOACH GUIDE WIRE.
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian