MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 4.0X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4244020W

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82214862 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during device preparation aviator plus 4.0x20 142cm, a sterile heparin saline leaked from the balloon, so, it could not be used on the patient.There was no reported patient injury.The device was stored and prepped per the instructions for use.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the stylet or any of the sterile packaging.There was no difficulty removing the device from the hoop and/or removing the protective balloon cover.The catheter was never in an acute bend.The intended target/lesion was the carotid artery.The procedure was completed after the use of a non-cordis balloon with the same inflation device.Additional information was requested; however, the information was not obtained.The device is expected to be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g4, h1, h2, h3 and h6 as reported, during device preparation aviator plus 4.0x20 142cm, a sterile heparin saline leaked from the balloon, so, it could not be used on the patient.There was no reported patient injury.The device was stored and prepped per the instructions for use.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the stylet or any of the sterile packaging.There was no difficulty removing the device from the hoop and/or removing the protective balloon cover.The catheter was never in an acute bend.The intended target/lesion was the carotid artery.The procedure was completed after the use of a non-cordis balloon with the same inflation device.Additional information was requested; however, the information was not obtained.The product was returned for analysis.A non-sterile aviator plus.014 4.0x20 142cm balloon catheter was received for analysis inside a plastic bag.Per visual analysis, no physical characteristics could be observed at the naked eye.Functional test was performed on the unit.A syringe filled with water was attached to the inflation lumen and pressure was applied.A leakage was confirmed in the unit due to a ruptured on the balloon surface at the proximal area of the balloon.Per microscopic analysis, sem analysis was performed.Results showed that the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented no anomalies near to the balloon rupture.The outer surface presented evidence of scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could probably led to the rupture condition found on the received device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82214862 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ was confirmed via device analysis as a leakage of water was noted during functional analysis.However, the exact cause cannot be determined.Device analysis revealed scratch marks on the balloon surface near the rupture.It is likely procedural factors and handling of the device during preparation contributed to the reported event as evidenced by the results provided.The balloon material near the rupture appears to have been torn due to the interaction of the balloon with a sharp object from the outside of the balloon.According to the instructions for use ¿prior to use, the device should be examined to verify functionality and integrity, and ensure that its size is suitable for the specific procedure.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.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 or preventive action will be taken at this time.

• Brand Name: AVIATOR PLUS .014 4.0X20 142CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12434025
• MDR Text Key: 270628233
• Report Number: 9616099-2021-04842
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032005743
• UDI-Public: (01)20705032005743(17)240131(10)82214862
• Combination Product (y/n): N
• PMA/PMN Number: K071189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 4244020W
• Device Catalogue Number: 4244020W
• Device Lot Number: 82214862
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1