MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM6CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005006L

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82193115 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber rx 5mm x 6cm x 155cm percutaneous transluminal angioplasty (pta) balloon catheter was inflated at the lesion but ruptured at 10 atmospheres (atm).The device was removed intact (in one piece) from the patient.Therefore, it was replaced with a new unknown balloon catheter and the procedure was completed.There was no reported patient injury.The lesion was the right superficial femoral artery (sfa) to popliteal artery.The user was trained to the device.The device was stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any other of the sterile packaging components.There were no kinks, or any other damages noted to device prior to inserting into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have severe calcification and the vessel was noted to have little tortuosity.The lesion was noted to have a 100% stenosis.The device was being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.The catheter did not have any difficulty advancing through the vessel.There was no difficulty crossing the lesion.The device was never in an acute bend and was never kinked while being used.The non-cordis inflation device was used successfully with other devices during the procedure.The device was discarded and will not be returned for evaluation.

Event Description

As reported, the balloon of a saber rx 5mm x 6cm x 155cm percutaneous transluminal angioplasty (pta) balloon catheter was inflated at the lesion but ruptured at 10 atmospheres (atm).The device was removed intact (in one piece) from the patient.Therefore, it was replaced with a new unknown balloon catheter and the procedure was completed.There was no reported patient injury.The lesion was the right superficial femoral artery (sfa) to popliteal artery.The user was trained to the device.The device was stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any other of the sterile packaging components.There were no kinks, or any other damages noted to device prior to inserting into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have severe calcification and the vessel was noted to have little tortuosity.The lesion was noted to have a 100% stenosis.The device was being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.The catheter did not have any difficulty advancing through the vessel.There was no difficulty crossing the lesion.The device was never in an acute bend and was never kinked while being used.The non-cordis inflation device was used successfully with other devices during the procedure.The device was discarded and will not be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of a saber rx 5mm x 6cm x 155cm percutaneous transluminal angioplasty (pta) balloon catheter was inflated at the lesion but ruptured at 10 atmospheres (atm).The device was removed intact (in one piece) from the patient.Therefore, it was replaced with a new unknown balloon catheter and the procedure was completed.There was no reported patient injury.The lesion was the right superficial femoral artery (sfa) to popliteal artery.The user was trained to the device.The device was stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any other of the sterile packaging components.There were no kinks, or any other damages noted to device prior to inserting into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have severe calcification and the vessel was noted to have little tortuosity.The lesion was noted to have a 100% stenosis.The device was being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.The catheter did not have any difficulty advancing through the vessel.There was no difficulty crossing the lesion.The device was never in an acute bend and was never kinked while being used.The non-cordis inflation device was used successfully with other devices during the procedure.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82193115 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿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 severe calcification likely contributed to the reported event.A chronically occluded vessel makes crossing into the lesion challenging; it is likely damage to balloon material occurred in the attempt to cross or upon inflation.However, without return of the product for analysis 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.

• Brand Name: SABER RX5MM6CM155
• 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: 14349464
• MDR Text Key: 293639539
• Report Number: 9616099-2022-05619
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032076064
• UDI-Public: (01)20705032076064(17)230531(10)82193115
• 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: 05/17/2022

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 Expiration Date: 05/31/2023
• Device Model Number: 51005006L
• Device Catalogue Number: 51005006L
• Device Lot Number: 82193115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Date Device Manufactured: 06/05/2020
• 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
• Treatment: AVEREST, MEDRTONIC.-INFLATION DEVICE.; UNK BALLOON CATHETER.