MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM20CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006020L

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, additional inflation was performed with 6mm 20cm 155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter.However, it could not keep the nominal pressure and gradually depressurize.It was deflated and removed.The rupture was not confirmed.Therefore, it was replaced with a new saber pta with different lot number.The procedure was completed by unknown drug coated balloon (dcb).There was no reported patient injury.A 3mm saber was used for pre-dilation.The lesion was the superficial femoral artery which had chronic total occlusion (cto).The lesion had mild calcification with no vessel tortuosity.The percentage of stenosis was 100%.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.Maintain negative pressure).A contralateral approach was made.A non-cordis guidewire crossed and changed to another non-cordis guidewire.A non-cordis inflation device was used.The same indeflator was used successfully with other devices.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 plunger was depressed into the syringe/indeflator when trying to inflate.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The product was returned for analysis.A non-sterile saber rx 6mm x 20cm 155 percutaneous transluminal angioplasty balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon of the unit seemed as have been previously inflated.No other physical characteristics could be observed at the naked eye.Per functional analysis, an inflation/deflation test was unsuccessfully intent to be performed.A lab sample inflator/deflator device filled with water was attached to the inflation lumen of the unit and positive pressure was applied.The saber was partially inflated because the balloon could not maintain its pressure due to a leakage observed on the body shaft area of the unit during inflation test, seemingly because of a torn area observed on the body shaft.Per microscopic analysis, sem analysis was performed results showed the torn area of the body/shaft of the saber rx 6 mm 20 cm 155 unit presented evidence of scratch marks along the torn area on the body/shaft material.This type of damage is commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft probably led to the torn condition found on the received device.It seems the body/shaft material near the rupture was torn either due to the interaction of the unit with calcified spicules located on the lesion or with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82203705 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty - partial or slow¿ and secondary findings of ¿body/shaft frayed/split/torn¿ were confirmed during device analysis.However, the exact cause cannot be determined.A leakage was confirmed through analysis of the returned device as a tear was noted on the body/shaft.The outer surface of the body/shaft presented evidence of scratch marks adjacent to the torn area.It is likely vessel characteristics of calcification with a chronic total occlusion contributed to the reported event as evidenced by device analysis.The body/shaft material appears to have been torn either due to the interaction of the shaft with calcified spicules located on the lesion or with a sharp object from the outside of the shaft.According to the instructions for use, which are not intended to mitigate risk, ¿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.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.¿ 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.

Event Description

As reported, additional inflation was performed with 6mm 20cm 155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter.However, it could not keep the nominal pressure and gradually depressurize.It was deflated and removed.The rupture was not confirmed.Therefore, it was replaced with a new saber pta with different lot number.The procedure was completed by unknown drug coated balloon (dcb).There was no reported patient injury.The device was returned for evaluation and the saber was partially inflated because the balloon could not maintain its pressure due to a leakage observed on the body shaft area of the unit during inflation test, seemingly because of a torn area observed on the body shaft.A 3mm saber was used for pre-dilation.The lesion was the superficial femoral artery which had chronic total occlusion (cto).The lesion had mild calcification.There was no vessel tortuosity.The percentage of stenosis was 100%.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.Maintain negative pressure).A contralateral approach was made.A non-cordis guidewire crossed and changed to another non-cordis guidewire.A non-cordis inflation device was used.The same indeflator was used successfully with other devices.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 plunger was depressed into the syringe/indeflator when trying to inflate.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.

• Brand Name: SABER RX6MM20CM155
• Type of Device: 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: 12431370
• MDR Text Key: 270628080
• Report Number: 9616099-2021-04838
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075302
• UDI-Public: (01)20705032075302(17)231031(10)82203705
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 51006020L
• Device Catalogue Number: 51006020L
• Device Lot Number: 82203705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1