MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005030L

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, a 2mm non-cordis balloon catheter was used for pre dilation and the saber rx 5mm x 30cm 155 percutaneous transluminal angioplasty (pta) was used.The device was inflated to five atmospheres (atm) but it ruptured.It was replaced with another 5mm non-cordis balloon catheter and it was used without any problems.The balloon was removed completely from the patient.There was no reported patient injury.The patient recovered after the event.The lesion was the superficial femoral artery which had a chronic total occlusion (cto).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 or other damages noted prior to inserting the product into the patient.The device prepped normally.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 was not returned for analysis as it was discarded by mistake.A product history record (phr) review of lot 82214541 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 a chronic total occlusion 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, a 2mm non-cordis balloon catheter was used for pre dilation and the saber rx5mm30cm155 percutaneous transluminal angioplasty (pta) was used.The device was inflated at 5 atmosphere (atm) but it ruptured.It was replaced with another 5mm non-cordis balloon catheter and it was used without any problems.The balloon was removed completely from the patient.There was no reported patient injury.The patient recovered after the event.The lesion was the superficial femoral artery which had a chronic total occlusion (cto).There was no difficulty removing the product from the hoop or when 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 the product into the patient.The device prepped normally.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 will not be returned for evaluation as the device was discarded by mistake.

• Brand Name: SABER RX5MM30CM155
• 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: 12778761
• MDR Text Key: 283689865
• Report Number: 9616099-2021-05045
• Device Sequence Number: 1
• Product Code: LIT
• 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
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 51005030L
• Device Catalogue Number: 51005030L
• Device Lot Number: 82214541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2021
• 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: (5MM JADE, ORBUS NEICH); 2MM JADE BALLOON CATHETER