MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005010L

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: a saber rx (5mm x 10cm x 155cm) percutaneous transluminal angioplasty (pta) balloon catheter was delivered and inflated to six atmospheres (atm); however, pressure could not be applied at 14 atm during its second inflation. The lesion was the left superficial femoral artery which had severe stenosis. The device was removed from the patient¿s body and balloon rupture was confirmed. Therefore, it was replaced with a new non-cordis balloon catheter and it was inflated to 14 atm. A guide wire crossed the lesion and the procedure was completed by drug-coated balloon performance. There was no reported patient injury. The product was not returned for analysis. A product history record (phr) review of lot 17657904 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 severe stenosis may have contributed to the reported event. However, without the return of the product for analysis it is difficult to draw a clinical conclusion between the device and 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, a saber rx (5mm10cm155) percutaneous transluminal angioplasty (pta) balloon catheter was delivered and inflated at 6 atmospheres (atm); however, pressure could not be applied at 14 atm during its second inflation. The device was removed from the patient body. Balloon rupture was confirmed; therefore, it was replaced with a new non-cordis balloon catheter and it was inflated at 14 atm. The procedure was completed by a drug-coated balloon performance. There was no reported patient injury. The lesion was the left superficial femoral artery which had severe stenosis. A guide wire crossed the lesion. The device was clinically used but will not be returned for analysis because of infectious disease.

• Brand Name: SABER RX5MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHELS; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8785859
• MDR Text Key: 150866963
• Report Number: 9616099-2019-03074
• 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,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/29/2020
• Device Model Number: 51005010L
• Device Catalogue Number: 51005010L
• Device Lot Number: 17657904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/12/2019 Patient Sequence Number: 1

Treatment

UNKNOWN BALLOON CATHETER