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

Catalog Number	48004010X
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	06/28/2024
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, 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the patient; however, the device did not remain in one piece during its removal.The separated segment was able to be withdrawn.The damage was not seen on the balloon material.A new 4mm x 15mm saber pta balloon catheter was used to complete the procedure.There were no reported injuries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.
Additional Manufacturer Narrative
This event no longer meets the definition of a malfunction that requires submission of a regulatory report.No additional reports will be forthcoming.This case is no longer considered reportable.Malfunction code of "pta/ptca system - separated" no longer applies.
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.

• 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: 19918891
• Report Number: 3007635982-2024-00203
• Device Sequence Number: 7087557
• Product Code: LIT
• UDI-Device Identifier: 20705032069479
• UDI-Public: (01)20705032069479(17)250131(10)82239700
• 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): 08/16/2024

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
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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