MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX3MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51003015L

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a 3mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation of a chronic totally occluded (cto) superficial femoral artery (sfa) lesion which showed no signs of tortuosity.There was no reported injury to the patient.The saberx pta balloon catheter was being used with an unknown guidewire when it ruptured.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation with a 50/50 contrast and saline mixture.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the balloon catheter.The device was able to track towards the lesion and cross the lesion without issue.The balloon catheter was never put into an acute bend and did not kink during this procedure.After the balloon ruptured, the balloon catheter was able to be removed easily from the patient and remained in one piece during removal.Information regarding the patient, possible presence of calcification at the target site, contrast used, number of atmospheres the device was inflated to, guidewire used, and the completion of the procedure was requested but not provided.The device was discarded and will not be returned.

Manufacturer Narrative

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

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, d4, g3, g4, g6, h1, h2, h3, h6, and h10 complaint conclusion: the balloon of a 3mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation of a chronic totally occluded (cto) superficial femoral artery (sfa) lesion which showed no signs of tortuosity.The saberx pta balloon catheter was being used with an unknown guidewire when it ruptured.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation with a 50/50 contrast and saline mixture.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the balloon catheter.The device was able to track towards the lesion and cross the lesion without issue.The balloon catheter was never put into an acute bend and did not kink during this procedure.After the balloon ruptured, the balloon catheter was able to be removed easily from the patient and remained in one piece during removal.Information regarding the patient, possible presence of calcification at the target site, contrast used, number of atmospheres the device was inflated to, guidewire used, and the completion of the procedure was requested but not provided.There was no reported injury to the patient.The device was not returned for analysis.A product history record (phr) review of lot 82193103 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿balloon~ burst¿ could not be confirmed and the exact root cause could not be determined.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that handling and procedural factors such as vessel characteristics of a chronic totally occluded (cto) superficial femoral artery (sfa) may have contributed to the reported event as the presence of calcification is known to cause damage to balloons.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 review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the balloon of a 3mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation of a chronic totally occluded (cto) superficial femoral artery (sfa) lesion which showed no signs of tortuosity.There was no reported injury to the patient.The saberx pta balloon catheter was being used with an unknown guidewire when it ruptured.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation with a 50/50 contrast and saline mixture.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the balloon catheter.The device was able to track towards the lesion and cross the lesion without issue.The balloon catheter was never put into an acute bend and did not kink during this procedure.After the balloon ruptured, the balloon catheter was able to be removed easily from the patient and remained in one piece during removal.Information regarding the patient, possible presence of calcification at the target site, contrast used, number of atmospheres the device was inflated to, guidewire used, and the completion of the procedure was requested but not provided.The device was discarded and will not be returned.

• Brand Name: SABER RX3MM15CM155
• 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: 14192914
• MDR Text Key: 289975336
• Report Number: 9616099-2022-05593
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075821
• UDI-Public: (01)20705032075821(17)230531(10)82193103
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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 Catalogue Number: 51003015L
• Device Lot Number: 82193103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Date Device Manufactured: 06/12/2020
• 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: UNK GUIDEWIRE