MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 5.5X15 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4245515W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
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, the 0.014¿ 5.5mm x 15mm x 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used; however, balloon leakage occurred at 6 atmospheric pressure (atm).Therefore, it was replaced with a new balloon catheter (unknown) and the procedure was completed.There was no reported patient injury.This was a renal artery stenosis (ras) case.The lesion had little calcification, no tortuosity, and 90% stenosis.The device used not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure).Iomeron contrast media was used.The contrast to saline ratio was 2:1.A non-cordis inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The patient was in in good physical condition.The device will not be returned for analysis as it was discarded due to infectious disease.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the 0.014¿ 5.5mm x 15mm x 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used; however, balloon leakage occurred at six atmospheric pressure (atm).Therefore, it was replaced with a new balloon catheter (unknown) and the procedure was completed.There was no reported patient injury.This was a renal artery stenosis (ras) case.The lesion had little calcification, no tortuosity, and 90% stenosis.The device used not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure).Non-cordis contrast media was used.The contrast to saline ratio was 2:1.A non-cordis inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The patient was in in good physical condition.The device was not returned for evaluation as the device was discarded due to infectious disease.A product history record (phr) review of lot: 82175573 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 5.5X15 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11279717
• Report Number: 9616099-2021-04236
• Device Sequence Number: 4108061
• Product Code: LIT
• UDI-Device Identifier: 20705032005859
• UDI-Public: 20705032005859
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 07/31/2022
• Device Model Number: 4245515W
• Device Catalogue Number: 4245515W
• Device Lot Number: 82175573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/04/2021
• 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: UNK.