MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO AVIATOR PLUS .014 6.0X15 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4246015W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a.014" 6mm x 15mm x 142mm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter was used as a pre-dilation, but it was not able to be inflated when pressure exceeded its nominal pressure.The doctor confirmed that the blood was pulled out and confirmed the rupture.There was no reported patient injury.This was a percutaneous transluminal renal angioplasty (ptra) case.The lesion was the stenosis at the right renal artery.An approach was made from the right femoral artery.The device was stored in the cath lab for six hours.The device was stored, handled, and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop, or removing the protective balloon cover.There was no difficulty removing the 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 balloon catheter was removed easily and intact.The device was not returned for analysis due to infectious disease.A product history record (phr) review of lot#: 82189078 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.Target lesion characteristics of stenosis most likely contributed the balloon rupture.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 instructions for use, although this is not intended as a mitigation, 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.
Event or Problem Description
As reported, a.014" 6mm x 15mm x 142mm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter was used as a pre-dilation; but it was not able to be inflated when pressure exceeded its nominal pressure.The doctor confirmed that the blood was pulled out and confirmed the rupture.There was no reported patient injury.This was a percutaneous transluminal renal angioplasty (ptra) case.The lesion was the stenosis at the right renal artery.An approach was made from the right femoral artery.The device was stored in the cath lab for six hours.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop, or removing the protective balloon cover.There was no difficulty removing the 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 balloon catheter was removed easily and intact.The device will not be returned for analysis due to infectious disease.

• Brand Name: AVIATOR PLUS .014 6.0X15 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 10844554
• Report Number: 9616099-2020-04058
• Device Sequence Number: 3501775
• Product Code: LIT
• UDI-Device Identifier: 20705032005897
• UDI-Public: 20705032005897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: 02/28/2023
• Device Model Number: 4246015W
• Device Catalogue Number: 4246015W
• Device Lot Number: 82189078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1