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

Catalog Number	48002020X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82275915 presented no issues during the manufacturing process that can be related to the reported event.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As reported, the 2mm 20cm saber balloon could not be filled inside the body and was tested after being withdrawn and was found to be leaking.There was no reported injury to the patient.The device will be returned for evaluation.
Event or Problem Description
As reported, the 2mm 20cm saber balloon could not be filled inside the body and was tested after being withdrawn and was found to be leaking.The device was removed intact from the patient.The case was completed with a non-cordis balloon.There was no reported injury to the patient.The device was stored properly according to the instruction for use (ifu).There was no difficulty removing the product from the hoop, removing the device from the balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.The lesion was in the posterior tibial artery below the knee and the intension was for ptca.The lesion had mild calcification.The vessel was noted to have mild tortuosity.The lesion had a 75% stenosis.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.There was no difficulty advancing the device through the vessel.There was no difficulty crossing the lesion.The device was never in an acute bend and was never kinked during use.The contrast/saline ratio was 1:1.The device will be returned for evaluation.
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 Manufacturer Narrative
As reported, the 2mm x 20cm saber percutaneous transluminal angioplasty balloon catheter could not be filled inside the body and was tested after being withdrawn and was found to be leaking.The device was removed intact from the patient.The case was completed with a non-cordis balloon.There was no reported injury to the patient.The device was stored properly according to the instruction for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally and was able to maintain negative pressure per the ifu.The lesion was in the posterior tibial artery below the knee and the intension was for pta.The lesion had mild calcification and 75% stenosis.The vessel was noted to have mild tortuosity.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.There was no difficulty advancing the device through the vessel or while crossing the lesion.The device was never in an acute bend and was never kinked during use.The contrast/saline ratio was 1:1.The product was returned for analysis.A non-sterile ¿saber 2mm20cm 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 no damages or anomalies were observed during the unaided eye visual inspection.The balloon was received deflated.Functional testing was performed, an inflator/deflator device was attached to the inflation port.Positive pressure was applied with the purpose of reaching the rated burst pressure.However, inflation was not possible due to a leakage noted on the body of the balloon.Sem analysis was executed to evaluate the surface of the balloon received.During the sem analysis evaluation scratch marks were observed near the puncture.The scratch marks observed could be related to exposure of the balloon surface with a sharp object from the outside of the device.A product history record (phr) review of lot 82275915 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ was confirmed during device analysis as a leakage of water was noted during functional analysis.However, the exact cause cannot be determined.Sem analysis was performed, results showed that the leakage on the balloon was caused by a puncture on the external balloon material which presented evidence of scratch marks near the damage.Scratch marks are commonly caused during the interaction of the material with a sharp object or mechanical damage.The balloon material near the rupture appears to have been punctured either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.It is likely vessel characteristics, procedural and/or handling factors contributed to the condition of the unit based on the information available for review.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.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.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.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• 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: 19009316
• Report Number: 3007635982-2024-00076
• Device Sequence Number: 9372268
• Product Code: LIT
• UDI-Device Identifier: 20705032069219
• UDI-Public: (01)20705032069219(17)260531(10)82275915
• 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): 06/05/2024

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: 05/31/2026
• Device Catalogue Number: 48002020X
• Device Lot Number: 82275915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• 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: 03/28/2024; 05/21/2024
• Initial Report FDA Received Date: 03/31/2024
• Supplement Report FDA Received Date: 04/22/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: UNK.
• Patient Sex: Unknown