MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM6CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51006006L

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82191577 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, a 6mm x 6cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was being used for post dilation of two implanted s.M.A.R.T self-expanding stent (ses) when the balloon ruptured at 14 atmospheres (atm).After the rupture occurred, the balloon was able to be successfully removed in one piece and the procedure was ended.There was no reported injury to the patient.This was during an interventional procedure to treat a severely calcified, chronic totally occluded (cto) lesion in the iliac artery which had a stenosis of 90%.There was no tortuosity to the target vessel.An 8mm x 100mm s.M.A.R.T.Self-expanding stent (ses) was implanted in the external iliac artery followed by the implantation of an 10mm x 60mm s.M.A.R.T self-expanding stent (ses) in the common iliac artery.The 6mm x 6cm 155cm saberx pta balloon catheter was then used for post dilation and was successfully inflated to nominal pressure for a duration of 30 seconds; however, the inflation was insufficient, and a second inflation to burst pressure was attempted.During the second inflation of the 6mm x 6cm 155cm saberx pta, the balloon ruptured at 14 atm and was removed.The 6mm x 6cm 155cm saberx pta balloon catheter was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.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.A 50-50 contrast and saline mixture was used to prep the balloon.There was no resistance or friction experienced as the device was being inserted.The device was able to track toward the lesion and cross the lesion without issue.The saberx pta balloon catheter was never in an acute bend and did not kink during its use.The device was discarded and will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, a 6mm x 6cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was being used for post dilation of two implanted s.M.A.R.T self-expanding stent (ses) when the balloon ruptured at 14 atmospheres (atm).After the rupture occurred, the balloon was able to be successfully removed in one piece and the procedure was ended.There was no reported injury to the patient.This was during an interventional procedure to treat a severely calcified, chronic totally occluded (cto) lesion in the iliac artery which had a stenosis of 90%.There was no tortuosity to the target vessel.An 8mm x 100mm s.M.A.R.T.Self-expanding stent (ses) was implanted in the external iliac artery followed by the implantation of an 10mm x 60mm s.M.A.R.T self-expanding stent (ses) in the common iliac artery.The 6mm x 6cm 155cm saberx pta balloon catheter was then used for post dilation and was successfully inflated to nominal pressure for a duration of 30 seconds; however, the inflation was insufficient, and a second inflation to burst pressure was attempted.During the second inflation, the balloon ruptured at 14 atm and was removed.The saberx pta balloon catheter was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.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.A 50-50 contrast and saline mixture was used to prep the balloon.There was no resistance or friction experienced as the device was being inserted.The device was able to track toward the lesion and cross the lesion without issue.The saberx pta balloon catheter was never in an acute bend and did not kink during its use.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82191577 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.The device was used for post-dilation of an implanted stent, stent struts can easily damage balloon material if caution is not met when attempting to cross inside the stent and upon inflation.The vessel was also described as severely calcified with 90% stenosis and was a chronic total occlusion; these characteristics may have also contributed to the events reported.However, without the 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 RX6MM6CM155
• 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: 14192171
• MDR Text Key: 289958881
• Report Number: 9616099-2022-05588
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032076118
• UDI-Public: (01)20705032076118(17)230331(10)82191577
• 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: 04/28/2022

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: 03/31/2023
• Device Catalogue Number: 51006006L
• Device Lot Number: 82191577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Date Device Manufactured: 04/23/2020
• 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: 10MM X 60MM S.M.A.R.T SELF-EXPANDING STENT (SES); 8MM X 100MM S.M.A.R.T. SELF-EXPANDING STENT (SES)
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 42 KG