MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 4.5X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4244520W

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17766962 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 a carotid artery stenting (cas) procedure, a.014 4.5x20 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter used for post dilation of a non-cordis stent, ruptured at approximately three atmospheres (3 atm).The rupture was confirmed by contrast media on angiography.The device was therefore removed from the patient¿s body and was replaced with a new same sized non-cordis balloon catheter to complete the procedure.There was no reported patient injury.The device will not be returned as it was discarded in the hospital.

Manufacturer Narrative

During a carotid artery stenting (cas) procedure an.014 aviator plus 4.5mm x 2mm 142cm percutaneous transluminal angioplasty (pta) balloon catheter was used for post dilation of a non-cordis stent and it ruptured at approximately three atmospheres (3 atm).The rupture was confirmed by contrast media on angiography.The device was therefore removed from the patient¿s body and was replaced with a new same sized non-cordis balloon catheter to complete the procedure.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17766962 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.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event however procedural/handling factors and vessel characteristics (although unknown) might have contributed to the reported event as the potential presence of calcification is known to cause damage to balloons.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.

• Brand Name: AVIATOR PLUS .014 4.5X20 142CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9440608
• MDR Text Key: 199106554
• Report Number: 9616099-2019-03393
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032005774
• UDI-Public: 20705032005774
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 4244520W
• Device Lot Number: 17766962
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BALLOON CATHETER; UNKNOWN STENT