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

Catalog Number	48004020X
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of a 4mm x 20cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to hold pressure.After removing the device, the device was flushed, and the balloon was found to have a pin hole in it.A new 4mm x 15cm saber pta balloon catheter was used as a replacement.There were no reported injuries to the patient.The device was stored and prepared according to the instructions for use (ifu) without any difficulty in removing the sterile packaging components.During preparation, the device successfully maintained negative pressure.The target vessel for the procedure was the superficial femoral artery (sfa).The characteristics of the target site vessel included severe calcification, with no tortuosity, and a stenosis percentage of 75%.The reported ¿balloon frayed/split/torn¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.The reported severe calcification and severe stenosis of the superficial femoral artery may have contributed to the reported event; it is likely to have caused damage to the balloon material that led to the pinhole reported.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.The rated burst pressure is based on the results of in vitro testing.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 4mm x 20cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to hold pressure.After removing the device, the device was flushed, and the balloon was found to have a pin hole in it.A new 4mm x 15cm saber pta balloon catheter was used as a replacement.There were no reported injuries to the patient.The device was stored and prepared according to the instructions for use (ifu) without any difficulty in removing the sterile packaging components.During preparation, the device successfully maintained negative pressure.The target vessel for the procedure was the superficial femoral artery (sfa).The characteristics of the target site vessel included severe calcification, with no tortuosity, and a stenosis percentage of 75%.The device was discarded and will not be returned.

• 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: 20256833
• Report Number: 3007635982-2024-00229
• Device Sequence Number: 15450560
• Product Code: LIT
• UDI-Device Identifier: 20705032069493
• UDI-Public: (01)20705032069493(17)270430(10)82309674
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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: 48004020X
• Device Lot Number: 82309674
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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: 4MM X 15CM SABER PTA BALLOON CATHETER
• Patient Age: 62 YR
• Patient Sex: Female