MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM20CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005020L

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber rx 5mm 20cm 155 ruptured during the initial inflation at 6 atm while in the left superficial femoral artery.This was during the pre-dilation.The balloon was removed from the patients body intact and the procedure was completed with a new non-cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks, or any other damages noted prior to inserting the device into the patient.The device was prepped per the ifu and was able to maintain negative pressure.A contralateral approach was made.The intended lesion was in the superficial femoral artery, which was noted to have a chronic total occlusion (cto).The lesion has 100% stenosis.The lesion was noted to have moderate calcification.The vessel had moderate tortuosity.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or while inserting through the guide catheter.The balloon catheter did not have any difficulty advancing through the vessel and crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The inflation device used was used successfully with other device during procedure.The device will not be returned for evaluation as it was discarded.

Manufacturer Narrative

As reported, the balloon of a saber rx 5mm x 20cm 155 ruptured during the initial inflation at six atm while in the left superficial femoral artery.This was during the pre-dilation.The balloon was removed from the patient¿s body intact and the procedure was completed with a new non-cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks, or any other damages noted prior to inserting the device into the patient.The device was prepped per the ifu and was able to maintain negative pressure.A contralateral approach was made.The intended lesion was in the superficial femoral artery, which was noted to have a chronic total occlusion (cto).The lesion has 100% stenosis.The lesion was noted to have moderate calcification.The vessel had moderate tortuosity.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or while inserting through the guide catheter.The balloon catheter did not have any difficulty advancing through the vessel and crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The inflation device used was used successfully with other device during procedure.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82221004 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of chronic total occlusion with 100% stenosis and moderate calcification likely contributed to the reported event.A chronically occluded vessel makes crossing into the lesion difficult; damage to balloon material may have occurred in the attempt to cross or during inflation.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device and the reported event.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.

Event Description

As reported, the balloon of a saber rx 5mm 20cm 155 ruptured during the initial inflation at 6 atm while in the left superficial femoral artery.This was during the pre-dilation.The balloon was removed from the patients body intact and the procedure was completed with a new non-cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks, or any other damages noted prior to inserting the device into the patient.The device was prepped per the ifu and was able to maintain negative pressure.A contralateral approach was made.The intended lesion was in the superficial femoral artery, which was noted to have a chronic total occlusion (cto).The lesion has 100% stenosis.The lesion was noted to have moderate calcification.The vessel had moderate tortuosity.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or while inserting through the guide catheter.The balloon catheter did not have any difficulty advancing through the vessel and crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The inflation device used was used successfully with other device during procedure.The device will not be returned for evaluation as it was discarded.

• Brand Name: SABER RX5MM20CM155
• 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: 14349558
• MDR Text Key: 292843579
• Report Number: 9616099-2022-05620
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032076002
• UDI-Public: (01)20705032076002(17)240430(10)82221004
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 51005020L
• Device Catalogue Number: 51005020L
• Device Lot Number: 82221004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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
• Treatment: UNK BALLOON CATHETER.