MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 6.0X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4246020W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17623155 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 or Problem Description
During a carotid artery stent implantation, a.014 6.0x20 142cm aviator plus percutaneous transluminal angioplasty (pta)balloon catheter was attempted to be used for post-dilatation but it was found that there was a pinhole rupture at the tip of the balloon.The hole was noted after the packaging was opened, and the device was flushed.The device had been connected to the negative pressure pump.The device was not used and the procedure was completed using another balloon catheter.There was no reported patient injury.There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.There were no kinks or other damages noted prior to use.Iopamidol contrast media was used with a1:1, contrast to saline ratio.A non-cordis indeflator was used and it was used successfully with the other devices.Other additional procedural details were requested but were unknown.
Additional Manufacturer Narrative
During a carotid artery stent implantation, an.014 6.0 x 20 x 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter was attempted to be used for post-dilatation but it was found that there was a pinhole rupture at the tip of the balloon.The hole was noted after the packaging was opened, and the device was flushed.The device had been connected to the negative pressure pump.The device was not used, and the procedure was completed using another balloon catheter.There was no reported patient injury.There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.There were no kinks or other damages noted prior to use.Non-cordis contrast media was used with a 1:1 contrast to saline ratio.A non-cordis indeflator was used and it was used successfully with the other devices.Other additional procedural details were requested but were unknown.The product was returned for analysis.One non-sterile aviator plus.014 6.0 x 20 x 142cm was returned.Per visual analysis, the balloon was coiled inside a plastic bag and appears to have been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Functional analysis was performed, and balloon inflation was executed.A leakage of water was observed on the balloon¿s distal area during inflation testing.Per sem analysis, the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented bulged/peeled off material along the rupture.The outer surface presented evidence of scratch marks adjacent to the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17623155 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was confirmed through analysis of the returned device.The exact cause of the burst could not be determined.Based on the information available for review, procedural factors and handling of the device during preparation may have contributed to the reported event as it was noted prior to use in the patient.Analysis revealed scratch marks and bulged/peeled off material and scratch marks adjacent to the balloon rupture on the outer surface of the balloon.It appears the balloon material near the rupture was torn 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.
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: AVIATOR PLUS .014 6.0X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9511506
• Report Number: 9616099-2019-03427
• Device Sequence Number: 572252
• Product Code: LIT
• UDI-Device Identifier: 20705032005903
• UDI-Public: 20705032005903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 4246020W
• Device Catalogue Number: 4246020W
• Device Lot Number: 17623155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/27/2019; 01/14/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/24/2020; 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1