MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 6.0X40 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a.014¿ 6mm x 40mm x 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter; however, it ruptured at six atmospheres (atm).Therefore, the device was replaced with the same size saber rx pta balloon and the procedure was completed.There was no reported patient injury.The device was not returned for evaluation as it was discarded due to covid-19.A product history record (phr) review of lot 82184211 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 and procedural factors, although unknown, may have contributed to the reported event.However, without the return of the device for analysis and with the limited amount of information provided, 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, a.014¿ 6mm x 40mm x 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter, however, it ruptured at 6 atmospheres (atm).Therefore, the device was replaced with the same size saber rx pta balloon and the procedure was completed.There was no reported patient injury.The device will not be returned for evaluation as it was discarded due to covid-19.

• Brand Name: AVIATOR PLUS .014 6.0X40 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12631846
• Report Number: 9616099-2021-04925
• Device Sequence Number: 14583358
• Product Code: LIT
• UDI-Device Identifier: 20705032005927
• UDI-Public: (01)20705032005927(17)22123110)82184211
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 4246040W
• Device Lot Number: 82184211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1