MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA .018 HP 40 5X2; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4395020T

Device Problem Burst Container or Vessel (1074)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

As reported, a.018¿ 5 x 2 x 40 slalom high pressure (hp) percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the anastomotic stenosis part.However, it ruptured at 14 atmospheres (atm) during its initial inflation.Therefore, it was removed from the patient¿s body and replaced with a unknown 5mm diameter*2cm length balloon was used, and it was inflated.The balloon was removed completely from the patient.Although the lesion did not inflate sufficiently, but the procedure was completed.There was no reported patient injury.There was no problem with the storage condition or delivery of the device.This was a shunt pta case.There was no difficulty removing the product from the hoop or the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was prepped normally.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or when inserting through the guide catheter.The device will not be returned for evaluation as it was discarded.

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a.018¿ 5 x 2 x 40 slalom high pressure (hp) percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the anastomotic stenosis part; however, it ruptured at 14 atmospheres (atm) during its initial inflation.Therefore, it was removed from the patient¿s body and replaced with an unknown 5mm diameter*2cm length balloon was used and inflated.The balloon was removed completely from the patient.Although the lesion did not inflate sufficiently, the procedure was completed.There was no reported patient injury.There was no problem with the storage condition or delivery of the device.This was a shunt pta case.There was no difficulty removing the product from the hoop or the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or when inserting through the guide catheter.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 82196814 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.Without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.However, the procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and 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 or preventive action will be taken at this time.

• Brand Name: SLALOM PTA .018 HP 40 5X2
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12780299
• MDR Text Key: 281396731
• Report Number: 9616099-2021-05046
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 4395020T
• Device Catalogue Number: 4395020T
• Device Lot Number: 82196814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• 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
• Treatment: 2CM LENGTH BALLOON CATHETER; UNKNOWN 5MM DIAMETER