MAUDE Adverse Event Report: CORDIS CASHEL SABER RX8MM2CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51008002L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: a saber rx 8mm x 2cm 155cm percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion and inflated; however, it ruptured during nominal pressure.There was no reported patient injury.The target lesion was in the superficial femoral artery (sfa).The device was stored and handled per the instructions for use (ifu).There was not any difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were not any kinks or other damages noted prior to inserting the product into the patient.The same indeflator was used successfully with other devices.There was not any resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.There was not any difficulty advancing the balloon catheter through the vessel.The product was removed intact from the patient.The product was not returned for analysis.A product history record (phr) review of lot 17610329 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, although unknown, may have contributed to the reported event as the presence of calcification is known to cause damage to balloon material.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 limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, a saber rx 8mm x 2cm 155 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion, inflated, however it ruptured during it¿s nominal pressure.There was no reported patient injury.The target lesion was in the superficial femoral artery (sfa).The device was stored and handled per the instructions for use (ifu).There was not any difficulty removing the product from the hoop.There was not any difficulty removing the product from the protective balloon cover.There was not any difficulty removing the stylet or any of the sterile packaging components.There were not any kinks or other damages noted prior to inserting the product into the patient.The same indeflator was used successfully with other devices.There was not any resistance/friction while inserting the balloon through the rotating hemostatic valve.There was not any resistance/friction while inserting the balloon through the guide catheter.There was not any difficulty advancing the balloon catheter through the vessel.The product was removed intact from the patient.

• Brand Name: SABER RX8MM2CM155
• 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: 8743659
• MDR Text Key: 150854613
• Report Number: 9616099-2019-03041
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 51008002L
• Device Catalogue Number: 51008002L
• Device Lot Number: 17610329
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2016
• 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