MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 6.0X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4246020W

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a aviator plus.014 6.0x20 ruptured.It was replaced with another same sized unknown balloon catheter and the procedure completed.There was no reported injury to the patient.The product 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 product into the patient.The device was prepped per the ifu and was prepped normally.The procedure being performed was a balloon pulmonary angioplasty (bpa).The balloon did not rupture while in a stent.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 guide catheter.The device advanced through the vessel without difficulty.The catheter was noted to have been in an acute bend; however, it was noted the device was never kinked while being used.The device was removed from the patient intact (in one piece).The device was discarded and will not be returned for evaluation.Additional information was requested; however, the information was not obtained.

Manufacturer Narrative

As reported, the balloon of an aviator plus.014 6.0x20 ruptured.It was replaced with another same sized unknown balloon catheter and the procedure completed.There was no reported injury to the patient.The product 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 product into the patient.The device was prepped per the ifu and was prepped normally.The procedure being performed was a balloon pulmonary angioplasty (bpa).The balloon did not rupture while in a stent.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.The device advanced through the vessel without difficulty.The catheter was noted to have been in an acute bend; however, it was noted the device was never kinked while being used.The device was removed from the patient intact (in one piece).Additional information was requested; however, the information was not obtained.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 82185416 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 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.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.

• Brand Name: AVIATOR PLUS .014 6.0X20 142CM
• Type of Device: 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: 14753159
• MDR Text Key: 297736952
• Report Number: 9616099-2022-05728
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032005903
• UDI-Public: (01)20705032005903(17)221231(10)82185416
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2022

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 Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 4246020W
• Device Catalogue Number: 4246020W
• Device Lot Number: 82185416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/21/2022
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BALLOON CATHETER