MAUDE Adverse Event Report: CORDIS CASHEL SLALOM PTA .018 HP 80 8X4; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4398040S

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: during a shunt percutaneous transluminal angioplasty, a slalom balloon catheter (pta.018 hp 80 8x4) was delivered to the heavily calcified lesion and inflated to nominal pressure, however, the balloon ruptured.The device was replaced with another balloon catheter to complete the procedure.There was no patient injury reported.The device was not returned for analysis.A product history record (phr) review of lot 17591355 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 of the reported event could not be determined.Vessel characteristics of calcification may have contributed to the reported event, however without the return of the device for analysis it is not possible to draw a clinical conclusion between the device and the event.The procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and are therefore often resistant to balloon expansion increasing the likelihood of damage to the balloon.According to the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.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 shunt percutaneous transluminal angioplasty, a slalom balloon catheter (pta.018 hp 80 8x4) was delivered to the heavily calcified lesion and inflated to nominal pressure, however, the balloon ruptured.The device was replaced with another balloon catheter to complete the procedure.There was no patient injury reported.The device was clinically used and, due to infectious disease, will not be returned for analysis.

• Brand Name: SLALOM PTA .018 HP 80 8X4
• 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: 8473848
• MDR Text Key: 140635442
• Report Number: 9616099-2019-02820
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003159
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 4398040S
• Device Catalogue Number: 4398040S
• Device Lot Number: 17591355
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Date Device Manufactured: 09/26/2016
• 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