MAUDE Adverse Event Report: CORDIS CORPORATION SABER 7MM3CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48007003X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.Review of the manufacturing documentation associated with this lot# 82173086.Presented no issues during the manufacturing process that can be related to the reported complaint.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
Upon ballooning a severely calcified left common femoral artery at the proximal anastomosis of the stented area of a bypass graft, a 7mm x 3cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated to 13 atmospheres (atm); however, it burst and the whole balloon segment separated from the delivery catheter system on a.018 non-cordis guidewire.The balloon separated from the shaft on the.018 non-cordis guidewire v18.The product was removed intact from the patient in 2 pieces.The separated segment was removed by the wire through the sheath.The status of the patient is stable.There was no reported patient injury.The device was stored as per labeling and was opened in a sterile field.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the 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 prep normally.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.Vessel / lesion characteristics: the lesion was severely calcified , the vessel had minor tortuosity, the vessel was 90% stenosed and the device was not used for a chronic total occlusion (total occlusion >3 months).There was difficulty advancing the balloon catheter through the vessel.There also was difficulty crossing the lesion.The catheter was never in an acute bent.The plunger did depress into the syringe/indeflator when trying to inflate.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly g4,g6,h1,h2,h3 and h6.Upon ballooning a severely calcified left common femoral artery at the proximal anastomosis of the stented area of a bypass graft, a 7mm x 3cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated to 13 atmospheres (atm); however, it burst and the whole balloon segment separated from the delivery catheter system on an.018 non-cordis guidewire.The balloon separated from the shaft on the.018 non-cordis guidewire v18.The product was removed intact from the patient in 2 pieces.The separated segment was removed by the wire through the sheath.The status of the patient is stable.There was no reported patient injury.The device was stored as per labeling and was opened in a sterile field.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the 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 prep normally.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.Vessel/lesion characteristics: the lesion was severely calcified, the vessel had minor tortuosity, and was 90% stenosed.The device was not used for a chronic total occlusion (total occlusion >3 months).There was difficulty advancing the balloon catheter through the vessel.There also was difficulty crossing the lesion.The catheter was never in an acute bent.The plunger did depress into the syringe/indeflator when trying to inflate.One product was returned for analysis.A non-sterile saber 7mm x 3cm 150 balloon catheter along with an unknown.018¿ non-cordis guidewire was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon of the unit was received ruptured/separated at the proximal area of the balloon.The separated balloon distal portion of the unit was not returned for evaluation.No other anomalies could be observed.Functional analysis could not be performed on the unit due to the separated condition of the saber balloon the way it was received for evaluation.Per microscopic analysis, sem analysis was performed on the received balloon unit to identify the possible root cause of the separated condition on the balloon with the following results: results showed that the balloon¿s 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 probably led to the separation 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 82173086 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¿ 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 vessel was noted to be highly calcified with tortuosity and ninety percent stenosis.Sem analysis revealed the external surface of the balloon had scratch marks adjacent to the rupture likely due to calcified spicules from the lesion.It is very likely that these same factors caused the balloon to rupture; furthermore, these results would imply that vessel characteristics contributed to the event as it is known that calcification can cause damage to balloon material.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/preventive action will be taken at this time.

• Brand Name: SABER 7MM3CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11372636
• Report Number: 9616099-2021-04293
• Device Sequence Number: 19989844
• Product Code: LIT
• UDI-Device Identifier: 20705032069660
• UDI-Public: 20705032069660
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 48007003X
• Device Catalogue Number: 48007003X
• Device Lot Number: 82173086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONTRAST MEDIA VISIPAQUE; INDEFLATOR/SYRINGE) BOSTON SCIENTIFIC; UNK V-18 .018 WIRE
• Patient Age: 72 YR