MAUDE Adverse Event Report: CORDIS US. CORP AVIATOR PLUS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4244015W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82276840 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the.014 4.0x15 aviator plus was used.However, it ruptured at its nominal pressure.Therefore, it was replaced with a new non-cordis balloon catheter and the procedure was completed.There was no reported injury to the patient.The device will be returned for evaluation.
Event or Problem Description
As reported, the.014 4.0x15 aviator plus was used.However, it ruptured at its nominal pressure.Therefore, it was replaced with a new non-cordis balloon catheter and the procedure was completed.The product was removed intact from the patient.There was no reported injury to the patient.The device 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 the damages noted prior to inserting the device into the patient.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.The lesion was in the renal artery which had a 80% stenosis.The lesion was noted to have moderate calcification with mild vessel tortuosity.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/ friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/ friction while inserting the balloon through the unknown guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty noted while crossing the lesion with the balloon catheter.The device was never in an acute bend and was never kinked during use.The device was discarded.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h11.As reported, the.014 4.0x15 aviator plus percutaneous transluminal angioplasty (pta) balloon catheter was used.However, it ruptured at its nominal pressure.Therefore, it was replaced with a new non-cordis balloon catheter and the procedure was completed.There was no reported injury to the patient.The lesion was in the renal artery which had 80% stenosis.The lesion was noted to have moderate calcification with mild vessel tortuosity.The product was removed intact from the patient.The device 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 other damages noted prior to inserting the device into the patient.The device was prepped normally per the ifu and was able to maintain negative pressure.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/ friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the unknown guide catheter.There was no difficulty advancing the balloon catheter through the vessel or while crossing the lesion with the balloon catheter.The device was never in an acute bend and was never kinked during use.The device was not returned for evaluation.A product history record (phr) review of lot 82276840 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 moderate calcification with 80% 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 or preventive action will be taken at this time.

• Brand Name: AVIATOR PLUS
• 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 ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 19491918
• Report Number: 3007635982-2024-00145
• Device Sequence Number: 20624227
• Product Code: LIT
• UDI-Device Identifier: 20705032005736
• UDI-Public: (01)20705032005736(17)260228(10)82276840
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 4244015W
• Device Lot Number: 82276840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/09/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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: BALLOON CATHETER (NON-CORDIS)
• Patient Sex: Unknown