MAUDE Adverse Event Report: CORDIS CORPORATION 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the aviator plus.014 6.0x20 142cm balloon ruptured during the procedure.There was no reported patient injury.The product will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the aviator plus.014 6.0x20 142cm balloon ruptured during the procedure.There was no reported patient injury.The intended procedure was a peripheral interventional.The lesion was moderately calcified and had moderate vessel tortuosity.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 prepped normally (i.E.Maintain negative pressure).An indeflator device was used for inflation.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon did not inflate normally.Leakage was noted from the balloon.The balloon catheter did not kink while being used.The procedure was completed using other products.The device was not returned for evaluation.A product history record (phr) review of lot 82180545 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics such as moderate calcification with tortuosity 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.
Event or Problem Description
As reported, the aviator plus.014 6.0x20 142cm balloon ruptured during the procedure.There was no reported patient injury.The intended procedure was a peripheral interventional.The lesion was moderately calcified.There was moderate vessel tortuosity.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 prepped normally (i.E.Maintain negative pressure).An indeflator device was used for inflation.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon did not inflate normally.Leakage was noted from the balloon.The balloon catheter did not kink while being used.The procedure was completed using other products.The product will be returned for evaluation.

• Brand Name: AVIATOR PLUS .014 6.0X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12689400
• Report Number: 9616099-2021-04998
• Device Sequence Number: 14698956
• Product Code: LIT
• UDI-Device Identifier: 20705032005903
• UDI-Public: (01)20705032005903(17)221031(10)82180545
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 10/31/2022
• Device Model Number: 4246020W
• Device Catalogue Number: 4246020W
• Device Lot Number: 82180545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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
• Patient Sex: Unknown