MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM20CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005020L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

A 5mm x 20cm x 155cm saber rx percutaneous transluminal angioplasty (pta) catheter was used for pre-dilation before a non-cordis stent was implanted.However, the device ruptured at eight atmospheres (atm) during its second inflation.Expansion pressure is nominal for both the first and second times.There was no patient injury reported.The lesion was the superficial femoral artery with a chronic total occlusion and some calcification.The vessel had almost no tortuosity.The product was stored, handled, inspected, and prepped normally according to the instructions for use (ifu).There was nothing unusual noted about the device prior to use.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.There was no kinks or other damages noted prior to inserting the product into the patient.The balloon catheter did not kink while being used.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.A contralateral approach was made with a non-cordis sheath.A non-cordis guidewire crossed the lesion.There was no unusual force used at any time during the procedure.The product was removed easily and intact (in one piece) from the patient.The device was replaced with a new saber rx balloon catheter which was inflated and used to perform a post-dilation, and the procedure was completed successfully.The product was not returned for analysis.A product history record (phr) review of lot 82163045 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 chronic total occlusion and a calcified lesion may have contributed to the reported event, as calcification is known to damage balloon material.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 5mm x 20cm 155 saber rx percutaneous transluminal angioplasty (pta) catheter was used for pre-dilation before a non-cordis stent was implanted.However, the device ruptured at 8 atmospheres (atm) during its second inflation.Expansion pressure is nominal for both the first and second times.There was no patient injury reported.The lesion was the superficial femoral artery with chronic total occlusion and some calcification.The vessel had almost no tortuosity.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The device was prepped normally.There was nothing unusual noted about the device prior to use.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, the stylet, or any of the sterile packaging components.There was no kinks or other damages noted prior to inserting the product into the patient.The balloon catheter did not kink while being used.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The maximum inflation pressure was 8 atm.A contralateral approach was made with a non-cordis sheath.A non-cordis guidewire crossed the lesion.There was no unusual force used at any time during the procedure.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The device was replaced with a new 5-25 saber rx balloon catheter which was inflated and used to perform a post-dilation.The procedure was completed without patient injury.The device has been discarded in the hospital.

• Brand Name: SABER RX5MM20CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8932300
• MDR Text Key: 198345645
• Report Number: 9616099-2019-03165
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 51005020L
• Device Catalogue Number: 51005020L
• Device Lot Number: 82163045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/26/2019
• Date Device Manufactured: 11/13/2018
• 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