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

Catalog Number	4244520W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, this was a carotid artery stenting (cas) case, and an aviator plus.014 4.5x20 142cm was used for post dilation, however it ruptured at six atmospheres.There were no reported patient injuries.The aviator was replaced with a new kaneka balloon catheter and the procedure was completed.The device was discarded due to infection disease.The device was stored on a shelf in the cath lab.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The saline to contrast ratio was 1:2.The same indeflator was used successfully with other devices.The catheter was removed easily and intact.The target lesion was the internal carotid.The lesion was little calcified with no vessel tortuosity.The lesion had eighty percent stenosis.The device was not used for a chronic total occlusion.
Additional Manufacturer Narrative
An aviator plus.014 4.5x20 142cm was used for post dilation during a carotid artery stenting (cas) case.The balloon ruptured at six atmospheres.There were no reported patient injuries.The target lesion was the internal carotid.The lesion was eight percent stenosed with little calcification and no vessel tortuosity.The device was stored on a shelf in the cath lab.The device was stored, handled and prepped normally (i.E.Maintain negative pressure) per the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The catheter was removed easily and intact.The saline to contrast ratio was 1:2.The same indeflator was used successfully with other devices.The device was not used for a chronic total occlusion.The aviator was replaced with a new balloon catheter and the procedure was completed.The device was not returned for evaluation as the device was discarded due to patient¿s infectious disease.A product history record (phr) review of lot 17613583 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.Vessel characteristics such as calcification and stenosis may have contributed to the reported event as calcification is known to damage balloon material.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 warnings in the safety information in 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/preventive action will be taken at this time.

• Brand Name: AVIATOR PLUS .014 4.5X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9261480
• Report Number: 9616099-2019-03314
• Device Sequence Number: 1879739
• Product Code: LIT
• UDI-Device Identifier: 20705032005781
• UDI-Public: 20705032005781
• 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): 11/11/2019

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: 10/31/2019
• Device Catalogue Number: 4244520W
• Device Lot Number: 17613583
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1