MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006004L

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82222005 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 6mm 4cm 155 ruptured at 8atm.The device was delivered and inflated at the lesion in the superficial femoral artery (sfa).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.The device was prepped per the ifu.The device was prepped normally and was sable to maintain negative pressure.The procedure being performed was an evt in the superficial femoral artery (sfa).The vessel was noted to have mild tortuosity and the lesion to have mild calcification.The lesion had a 90% stenosis.The device was not being used to treat a chronic total occlusion.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.The device did not have any difficulty while advancing through the vessel or while crossing the lesion.It was noted that the device was at some point in an acute bend; however, it was never kinked while being used.The device was removed intact (in one piece) from the patient).The case was completed after the use of an unknown device.The device will not be returned as it was discarded.

Event Description

As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at 8atm.The device was delivered and inflated at the lesion in the superficial femoral artery (sfa).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.The device was prepped per the ifu.The device was prepped normally and was sable to maintain negative pressure.The procedure being performed was an evt in the superficial femoral artery (sfa).The vessel was noted to have mild tortuosity and the lesion to have mild calcification.The lesion had a 90% stenosis.The device was not being used to treat a chronic total occlusion.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.The device did not have any difficulty while advancing through the vessel or while crossing the lesion.It was noted that the device was at some point in an acute bend; however, it was never kinked while being used.The device was removed intact (in one piece) from the patient).The case was completed after the use of an unknown device.The device will not be returned as it was discarded.

Manufacturer Narrative

As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at eight atm.The device was delivered and inflated at the lesion in the superficial femoral artery (sfa).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.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.The procedure being performed was an evt in the superficial femoral artery (sfa).The vessel was noted to have mild tortuosity and the lesion to have mild calcification.The lesion had 90% stenosis.The device was not being used to treat a chronic total occlusion.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.The device did not have any difficulty while advancing through the vessel or while crossing the lesion.It was noted that the device was at some point in an acute bend; however, it was never kinked while being used.The device was removed intact (in one piece) from the patient).The case was completed after the use of an unknown device.The device was not returned for evaluation as the device was discarded.A product history record (phr) review of lot 82222005 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 stenosis and mild calcification likely contributed to the reported event, as calcification is known to damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.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 RX6MM4CM155
• 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; miamilakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14000031
• MDR Text Key: 290097252
• Report Number: 9616099-2022-05506
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032076101
• UDI-Public: (01)20705032076101(17)240531(10)82222005
• 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: 04/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 51006004L
• Device Catalogue Number: 51006004L
• Device Lot Number: 82222005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Date Device Manufactured: 06/15/2021
• 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.