MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 5.0X30 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4245030W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During use in a coronary artery stenting case, an aviator plus was used for a post dilation but it ruptured at eight atmosphere (8 atm).There was no patient injury.The aviator plus was replaced with another balloon catheter (competitive product) and the procedure completed.The physician commented that this issue might have occurred by the stent edge.There was no reported patient injury.The device will not be returned for analysis.
Additional Manufacturer Narrative
An aviator plus ruptured at eight atmospheres (8 atm) during use for a post dilation in a coronary artery stenting case.There was no reported patient injury.The procedure was completed with a non- cordis balloon catheter.The physician commented that this issue might have occurred by the stent edge.The device was not returned for analysis.A product history record (phr) review of lot 82165025 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 could not be determined.Target lesion characteristics (physician commented that it may have ruptured at the stent edge) most likely contributed the balloon rupture.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use, although this is not intended as a mitigation, ¿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 5.0X30 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary, 0000 ; EI 0000
• MDR Report Key: 9243441
• Report Number: 9616099-2019-03310
• Device Sequence Number: 306061
• Product Code: LIT
• UDI-Device Identifier: 20705032005835
• UDI-Public: 20705032005835
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 12/31/2021
• Device Model Number: 4245030W
• Device Catalogue Number: 4245030W
• Device Lot Number: 82165025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/27/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BALLOON CATHETER.