MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM6CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005006L

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: during a poba (plain old balloon angioplasty), a saber rx balloon catheter (5mm x 6cm x 155cm) was delivered to the lesion in the iliac artery for pre-dilation; however, the balloon ruptured at five atmospheres (5atm).The lesion was described as not severely calcified.The device was replaced with a new balloon catheter to continue the procedure.There was no patient injury reported.The device was not returned for analysis.A product history record (phr) review of lot 17487847 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.With the paucity of information available and without return of the product for analysis it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to 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/preventive action will be taken at this time.

Event Description

As reported, during a poba (plain old balloon angioplasty), a saber balloon catheter (rx5mm6cm155) was delivered to the lesion in the iliac artery for pre-dilation, however, the balloon ruptured at 5 atmospheres (atms).The device was replaced with a new balloon catheter to continue the procedure.The lesion was described as not severely calcified.There was no patient injury reported.The device was clinically used and will not be returned for analysis due to infectious disease.

• Brand Name: SABER RX5MM6CM155
• 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: 8573453
• MDR Text Key: 143864494
• Report Number: 9616099-2019-02891
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2019

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: 04/30/2019
• Device Model Number: 51005006L
• Device Catalogue Number: 51005006L
• Device Lot Number: 17487847
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 05/02/2019
• Date Device Manufactured: 05/12/2016
• 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