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

Catalog Number	48003030X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of a 3mm x 30cm saber percutaneous transluminal angioplasty (pta) balloon catheter could not be filled and was leaking contrast from the balloon material.There were no reported injuries to the patient.The device was stored and prepped according to the instruction for use (ifu), and there was no difficulty removing any of the sterile packaging components.During preparation, the device maintained negative pressure.The contrast to saline ratio used was 50:50.The target vessel was characterized by severe calcification, no tortuosity, and 80% stenosis.The balloon was able to be partially inflated and there was no difficulty deflating the balloon.The reported ¿balloon leakage during positive pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.The reported severe calcification of the common iliac artery, as well as the 80% stenosis reported, may have contributed to the reported event; it is likely to have caused damage to the balloon material that led to leaking from the balloon material.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device and the reported event.According to the warnings in 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.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.Use of a pressure monitoring device is recommended to prevent over-pressurization.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ the information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
As reported, the balloon of a 3mm x 30cm saber percutaneous transluminal angioplasty (pta) balloon catheter could not be filled and was leaking contrast from the balloon material.There were no reported injuries to the patient.The device was stored and prepped according to the instruction for use (ifu), and there was no difficulty removing any of the sterile packaging components.During preparation, the device maintained negative pressure.The contrast to saline ratio used was 50:50.The target vessel was characterized by severe calcification, no tortuosity, and 80% stenosis.The balloon was able to be partially inflated and there was no difficulty deflating the balloon.The device was discarded due to infectious disease.

• 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: 20239018
• Report Number: 3007635982-2024-00228
• Device Sequence Number: 8163084
• Product Code: LIT
• UDI-Device Identifier: 20705032069134
• UDI-Public: (01)20705032069134(17)271231(10)82303111
• 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): 09/17/2024

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 Catalogue Number: 48003030X
• Device Lot Number: 82303111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2024
• 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: MEDNO PRESSURE PUMPS.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian