MAUDE Adverse Event Report: CORDIS CORPORATION SABER 4MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48004015X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 4mm x 15cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter burst explosively at 6-7 atmospheres (atm).The saber was then pulled back; however, it got stuck to the guidewire (unknown).Both guidewire (unknown) and the saber were pulled partially back into the non-cordis sheath.The non-cordis sheath, with both the saber and the guidewire (unknown) were pulled back into the ipsilateral side.After removing from the patient, it showed that one marker and some pieces from the balloon material were left inside the patient.Therefore, a stent (unknown) was placed in the superficial femoral artery (sfa) to prevent the material from moving distally.The saber was used below the knee.The operator was trained to use the device.The lesion had little to no calcification.There vessel had little to no tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintained negative pressure).A non-cordis contrast media was used.The contrast to saline ratio was 50:50.A non-cordis inflation device was used (indeflator/syringe).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.An unknown 5x100 self-expandable stent was used to complete the procedure.The patient is now doing fine.The event caused a condition that required significant prolongation of existing hospitalization.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
Complaint conclusion: as reported, a 4mm x 15cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter burst explosively at six to seven atmospheres (atm).The saber was then pulled back; however, it got stuck to the guidewire (unknown).Both guidewire (unknown) and the saber were pulled partially back into the non-cordis sheath.The non-cordis sheath, with both the saber and the guidewire (unknown) were pulled back into the ipsilateral side.After removing from the patient one marker and some pieces from the balloon material were left inside the patient.Therefore, a stent (unknown) was placed in the superficial femoral artery (sfa) to prevent the material from moving distally.The saber was used below the knee.The operator was trained to use the device.The lesion had little to no calcification.There vessel had little to no tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintained negative pressure).A non-cordis contrast media was used.The contrast to saline ratio was 50:50.A non-cordis inflation device was used (indeflator/syringe).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.An unknown 5x100 self-expandable stent was used to complete the procedure.The patient is now doing fine.The event caused a condition that required significant prolongation of existing hospitalization.One product was returned for analysis.A non-sterile 4mm x 15cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter along with an unknown guidewire and a non-cordis sheath was received for analysis inside a plastic bag.Per visual analysis, the unknown guidewire was received introduced into the saber, and the saber, in turn, within the non-cordis sheath.The saber was received with the balloon ruptured- separated at the middle area of the balloon.The distal area separated section of the balloon was not returned for evaluation.No other physical characteristics could be observed at the naked eye.Per functional analysis, guidewire withdrawal test was intended to be performed.The unknown guidewire could not be retrieved from the saber.The wire was stuck to the unit.Several withdrawal attempts were exhausted without success.Therefore, soaking of the unit into a peroxide based disinfectant solution was performed.Then, the unit was immersed for three 20 minutes-cycles in an ultrasonic bath.The unit was cleansed by these means and the unknown guidewire was successfully removed from the unit despite the separated condition of the saber balloon.The saber was then removed from the non-cordis sheath.Neither resistance nor friction was experienced during removal at this time.Per microscopic analysis, sem analysis was performed, results showed that the balloon separation was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could have led to the ruptured condition found on the received device.It seems the balloon material near the rupture was torn 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.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82206159 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon- burst - at/below rbp¿, ¿guidewire lumen resistance/friction - in-patient¿ and "balloon- separated - in patient¿ were confirmed due to the condition of the product received.The exact cause of the balloon burst/separation could not be determined.The device was received with the unknown guidewire stuck inside the balloon catheter and was later removed after soaking and ultrasonic bath.Sem analysis revealed the external surface of the balloon had scratch marks adjacent to the rupture.It is likely vessel characteristics and procedural factors may have contributed to the reported events as evidenced by device analysis.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.¿ according to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ 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 4MM15CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12588438
• Report Number: 9616099-2021-04912
• Device Sequence Number: 4231352
• Product Code: LIT
• UDI-Device Identifier: 20705032069486
• UDI-Public: 20705032069486
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 48004015X
• Device Catalogue Number: 48004015X
• Device Lot Number: 82206159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/08/2021; 11/05/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/02/2021; 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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 GUIDEWIRE, UNK CROSSOVERSHEATH.
• Patient Sex: Male