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

Catalog Number	48004015X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Complete Neonatal Hearing Loss (4515)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82299298 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, a 4mm 15cm.018 saber pta balloon was put into the patient for standard ballooning of the sfa artery.Upon inflation, the balloon was not inflating fully, and the doctor noted that his indeflator/inflation device was unable to hold pressure, leading him to believe the balloon was broken/had a tear or hole somewhere.The rest of the case was finished with more cordis saber.018 balloons of different sizes, with no issues with further said balloons, or any of the other equipment used.There was no reported injury to the patient.The device was stored properly according to the instructions for use.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 device into the patient.The lesion was noted to have little calcification.The vessel did not have any 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.There was no resistance/ friction while inserting a balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the device.The catheter was never in an acute bend and was never kinked during use.The contrast/saline ratio was noted to be 50/50.The same inflation device was used successfully with other devices during the procedure.The device will be returned for evaluation.
Event or Problem Description
As reported, a 4mm 15cm.018 saber percutaneous transluminal angioplasty (pta) balloon was put into the patient for standard ballooning of the sfa artery.Upon inflation, the balloon was not inflating fully, and the doctor noted that his indeflator/inflation device was unable to hold pressure, leading him to believe the balloon was broken/had a tear or hole somewhere.The rest of the case was finished with more cordis saber.018 balloons of different sizes, with no issues with further said balloons, or any of the other equipment used.There was no reported injury to the patient.The device was stored properly according to the instructions for use.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 device into the patient.The lesion was noted to have little calcification.The vessel did not have any 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.There was no resistance/ friction while inserting a balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the device.The catheter was never in an acute bend and was never kinked during use.The contrast/saline ratio was noted to be 50/50.The same inflation device was used successfully with other devices during the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 4mm x 15cm.018 saber percutaneous transluminal angioplasty (pta) balloon was put into the patient for standard ballooning of the sfa artery.Upon inflation, the balloon was not inflating fully, and the doctor noted that his indeflator/inflation device was unable to hold pressure, leading him to believe the balloon was broken/had a tear or hole somewhere.The rest of the case was finished with more cordis saber.018 balloons of different sizes, with no issues with further said balloons, or any of the other equipment used.There was no reported injury to the patient.The device was stored properly according to the instructions for use.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 device into the patient.The lesion was noted to have little calcification.The vessel did not have any 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 balloon catheter through the vessel or crossing the lesion with the device.The catheter was never in an acute bend and was never kinked during use.The contrast/saline ratio was noted to be 50/50.The same inflation device was used successfully with other devices during the procedure.The device was returned for analysis.A non-sterile "saber 4mm15cm 150" was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed on a metallic tray to be inspected.A thorough inspection was performed on the unit observing that neither the balloon nor the shaft or luer hub present any damages or anomalies.The balloon was received deflated.No other outstanding details were noticed.Functional testing was performed, one inflator/deflator device was attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.A leak was observed in the body of the balloon.Sem analysis was not performed as the damages associated with leakage are visible with the magnification obtained with a vision system.The balloon was inspected observing a pin hole on the surface where the water is leaking.The balloon surface presented evidence of a burst condition and secondary scratch marks located near the damaged border.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the surface could have led to the damaged condition found on the received device.It seems that the material near the damaged area was affected with a sharp object from the outside of the device.No other anomalies were observed during the analysis.A product history record (phr) review of lot 82299298 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 functional analysis.However, the exact cause could not be determined.Microscopic analysis revealed scratch marks on the outer portion of the balloon and a leakage was noted coming from the body of the balloon.It appears the balloon was damaged by the interaction of the balloon material with a sharp object like calcified spicules located on the lesion or a mechanical damage.Therefore, based on the analysis provided it is likely vessel characteristics contributed to the events reported.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: 19295973
• Report Number: 3007635982-2024-00126
• Device Sequence Number: 6892278
• Product Code: LIT
• UDI-Device Identifier: 20705032069486
• UDI-Public: (01)20705032069486(17)261130(10)82299298
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 48004015X
• Device Lot Number: 82299298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• 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: 06/18/2024
• Initial Report FDA Received Date: 05/12/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2023
• 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: CORDIS SABER .018
• Patient Sex: Unknown