MAUDE Adverse Event Report: CORDIS US. CORP AVIATOR PLUS .014 7.0X15 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4247015W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the aviator plus was used.However, the balloon ruptured at 8 atm.The device was replaced with another same sized aviator plus and additional inflation was performed.The procedure was completed.There was no reported injury to the patient.The lesion was the renal artery.An unknown guidewire was inserted.The device was discarded.Additional information was requested; however, the information was not obtained after multiple attempts.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, h1, h2, h3 and h6.As reported, the aviator plus was used.However, the balloon ruptured at eight atm.The device was removed intact from the patient.The device was replaced with another same sized aviator plus and additional inflation was performed.The procedure was completed.There was no reported injury to the patient.The lesion was the renal artery.An unknown guidewire was inserted.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks, or any other damages noted prior to inserting into the patient.The device was prepped normally and was able to maintain negative pressure as per the ifu.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.There was no difficulty advancing the balloon through the vessel and none noted while crossing the lesion.The lesion has mild calcification with 90% stenosis and the vessel had mild tortuosity.The device was not being used to treat a chronic total occlusion (cto).The catheter was never in an acute bend and was never kinked during use.The non-cordis inflation device was used successfully with other devices during the procedure.The balloon did not rupture while in a stent.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 82258292 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.It is likely procedural factors and vessel characteristics of mild calcification with 90% stenosis and vessel tortuosity, contributed to the reported event.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.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 and hub identification band.The compliance table printed on the box label and packaged with the product illustrates how the balloon diameter increases with increasing pressure.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.
Event or Problem Description
As reported, the aviator plus was used.However, the balloon ruptured at 8 atm.The device was removed intact from the patient.The device was replaced with another same sized aviator plus and additional inflation was performed.The procedure was completed.There was no reported injury to the patient.The lesion was the renal artery.An unknown guidewire was inserted.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks, or any other damages noted prior to inserting into the patient.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.There was no difficulty advancing the balloon through the vessel and none noted while crossing the lesion.The lesion has mild calcification and the vessel had mild tortuosity.The lesion had a 90% stenosis.The device was not being used to treat a chronic total occlusion (cto).The catheter was never in an acute bend and was never kinked during use.The non-cordis inflation device was used successfully with other devices during the procedure.The balloon did not rupture while in a stent.The device was discarded.

• Brand Name: AVIATOR PLUS .014 7.0X15 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16158112
• Report Number: 3009018440-2023-00024
• Device Sequence Number: 6958840
• Product Code: LIT
• UDI-Device Identifier: 20705032005934
• UDI-Public: (01)20705032005934(17)250930(10)82258292
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 09/30/2025
• Device Model Number: 4247015W
• Device Catalogue Number: 4247015W
• Device Lot Number: 82258292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/09/2023
• Date Device Manufactured: 10/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVIATOR PLUS .014 7.0X15 142CM; UNK GUIDEWIRE
• Patient Sex: Unknown