MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006015L

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: unk balloon catheter, goodman indeflator.Complaint conclusion: a saber rx 6mm x 15cm x 155cm percutaneous transluminal angioplasty (pta) balloon catheter (bc) was being used in the superficial femoral artery and ruptured due to calcification.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).There was little calcification, vessel tortuosity and vessel angulation.The device was not being used to treat chronic total occlusion (cto).There was not any resistance or friction while inserting the balloon through the rotating hemostatic valve.There was not any resistance or friction while inserting the balloon through the guide catheter or the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon ruptured around 10 atmospheres (atm).The balloon was inflated one time.The product was removed intact from the patient and replaced with a non-cordis balloon and the procedure was completed.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 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 device prepped normally.The same indeflator was used successfully with other devices.The product was not returned for analysis.A product history record (phr) review of lot 17662417 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is very likely that vessel characteristics of calcification contributed to the reported event, as calcification is known to cause damage to balloon material.However, it is difficult to make a clinical conclusion between the device and reported event without the return of the product for analysis.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, a saber rx 6mm x 15cm 155 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was being used in the superficial femoral artery and ruptured due to calcification.There was no reported patient injury.The saber rx was replaced with a non-cordis balloon and the procedure was completed.The target lesion was the superficial femoral artery (sfa).There was a little calcification.There was a little vessel tortuosity.There was a little vessel angulation.The device was not being used to treat chronic total occlusion (cto).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 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 device prepped normally.The same indeflator was used successfully with other devices.There was not any resistance or friction while inserting the balloon through the rotating hemostatic valve.There was not any resistance or friction while inserting the balloon through the guide catheter.There was not any difficulty advancing the balloon catheter through the vessel.There was not any difficulty crossing the lesion.The catheter was never in an acute bend.The balloon ruptured around 10 atmospheres (atm).The balloon was inflated one time.The product was removed intact from the patient.

• Brand Name: SABER RX6MM15CM155
• 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: 8615690
• MDR Text Key: 145531108
• Report Number: 9616099-2019-02951
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 51006015L
• Device Catalogue Number: 51006015L
• Device Lot Number: 17662417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2017
• 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