MAUDE Adverse Event Report: CORDIS DE MEXICO AVIATOR PLUS .014 5.0X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4245020W

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

During pre-dilation with an aviator plus (.014 5.0x20 142cm) balloon catheter (bc) to the common iliac artery, it was reported that the balloon catheter was delivered to the lesion but it ruptured.Therefore it was replaced with another aviator plus and the procedure finished successfully.There was no reported patient injury.An ipsilateral retrograde approach was made.A sheath introducer (6f 11cm) was inserted to the patient.   the lesion was mildly calcified and mildly tortuous.The rate of stenosis was 85%.The product was returned for analysis.  one non-sterile unit of aviator plus.014 5.0x20 142cm bc was returned.Per visual the balloon was previously inflated and deflated and the aviator outer body was found separated at 11.5 cm from the aviator distal end and the inner lumen was found elongated 7.2 cm.No other issues were found.Per functional analysis a leak test was performed and a leakage was observed on the balloon.Per microscopic analysis a pinhole was noted on the distal section of the balloon.The outer body of the device was noted to be separated at 11.5cm from its distal end.Per sem analysis the external surface revealed evidence of scratches and abrasion marks that could be related to the balloon pinhole.The internal surface and distal marker band did not reveal any evidence of damages.Outer body analysis results showed that the body presented evidence of elongations and plastic deformation; also, stress lines were presented at edges of the rupture point; these conditions are related to pulling stretching until separation occurs.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17378069 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "balloon burst" was not confirmed due to the technical definition of a burst, however a leakage was confirmed, which may appear to the user as a burst, through analysis of the returned device.The exact cause of the pinhole could not be determined during analysis.Based on the information available for review, vessel characteristics (mild calcification and tortuosity and a rate of stenosis of 85%) may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis.The reported "brite tip/distal tip separated" was confirmed through analysis of the returned device.The exact cause of the elongation could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced by elongations, plastic deformations and stress lines indicative of excessive force being applied noted on the device at the rupture point during analysis.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.Caution: if strong resistance is met during advancement or withdrawal of the balloon catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Note: if the balloon cannot be withdrawn through the guiding catheter, withdraw the balloon catheter and guiding catheter as a single unit." neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

Event Description

During pre-dilation with an aviator plus (.014 5.0x20 142cm) to the common iliac artery, it was reported that the balloon catheter was delivered to the lesion but it ruptured.Therefore it was replaced with another aviator plus and the procedure finished successfully.There was no reported patient injury.The product will be returned for analysis.N ipsilateral retrograde approach was made.A sheath introducer (6f 11cm) was inserted to the patient.ࠔhe lesion was mildly calcified and mildly tortuous.The rate of stenosis was 85%.Per visual analysis, the product's outer쳌dy was found separated at 11.5 cm from the aviator distal end and the inner lumen was found elongated 7.2 cm.

• Brand Name: AVIATOR PLUS .014 5.0X20 142CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014
• MDR Report Key: 6057986
• MDR Text Key: 58462691
• Report Number: 9616099-2016-00667
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032005828
• UDI-Public: 20705032005828
• 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: consumer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2016

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: 10/31/2018
• Device Model Number: 4245020W
• Device Catalogue Number: 4245020W
• Device Lot Number: 17378069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/18/2016
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: A SHEATH INTRODUCER (6F 11CM)