MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO AVIATOR PLUS .014 5.0X40 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the doctor proceeded to inflate the balloon but the.014 5.0 x 40 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter would not hold pressure and leakage was noted from the balloon.Therefore, the balloon was removed.There was no harm and no reported patient injury.The device was used in patient.The device was stored as per labeling and opened in sterile field.The balloon was prepped as per the instructions for use (ifu).The event occurred inside the patient during a procedure in the carotid artery.There was no difficulty removing any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device prepped normally.The contrast to saline ratio was 50/50.An indeflator was used as the inflation device and the same indeflator was used successfully with other devices.The plunger depressed into the syringe/indeflator when trying to inflate.Additional patient and procedural details were requested but were not available.The product was returned for analysis.A non-sterile unit of an aviator plus.014 5.0x40 142cm was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon has been previously inflated.Water residues were observed inside the balloon.No other anomalies were observed.Per functional analysis, balloon inflation was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A leakage of water was observed coming from the proximal area of the balloon.Per sem analysis on the balloon leakage observed during the functional test, results showed that the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface probably led to the ruptured condition found on the received device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82187207 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ was confirmed via device analysis as a leakage of water was noted during functional analysis.However, the exact cause cannot be determined.Device analysis revealed scratch marks on the balloon surface near the rupture.It is likely vessel characteristics contributed to the reported event as evidenced by the results provided.The balloon material near the rupture appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.According to 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.
Event or Problem Description
As reported, the doctor proceeded to inflate the balloon but the.014 5.0 x 40 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter would not hold pressure and leakage was noted from the balloon.Therefore, the balloon was removed.There was no harm and no reported patient injury.The device was used in patient.The device was stored as per labeling and opened in sterile field.The balloon was prepped as per the instructions for use (ifu).The device will be returned for analysis.The event occurred inside the patient during a procedure in the carotid artery.There was no difficulty removing any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product the product into the patient.The device prepped normally.The contrast to saline ratio was 50/50.An indeflator was used as the inflation device and the same indeflator was used successfully with other devices.The plunger depressed into the syringe/indeflator when trying to inflate.Additional patient and procedural details were requested but were not available.

• Brand Name: AVIATOR PLUS .014 5.0X40 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: 11663935
• Report Number: 9616099-2021-04406
• Device Sequence Number: 14227462
• Product Code: LIT
• UDI-Device Identifier: 20705032005842
• UDI-Public: 20705032005842
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 4245040W
• Device Lot Number: 82187207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1