MAUDE Adverse Event Report: CORDIS DE MEXICO AVIATOR PLUS .014 5.0X30 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4245030W

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of two products involved with the reported event.The manufacturing reference number for this product is case-(b)(6).The manufacturing reference number for the other complaint is case-(b)(6).The device was received for analysis; but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review and additional information are also pending, and will be submitted within 30 days upon receipt.

Event Description

As reported, when pumping pressure, the user found the balloon of a 5x30mm aviator plus.014 142cm was leaking during negative pressure before insertion into the patient. another cordis device was used to replace the aviator.After the user removed the 7x30mm precise pro rx stent delivery system (sds) from the product packaging, the user found the stent was exposed.Another cordis stent was used to complete the procedure.There was no patient injury as the devices were not used in the patient.The devices will be returned for analysis.The intended procedure/target lesion was unknown.There were no difficulty removing the aviator balloon catheter from the hoop, balloon cover, or stylet.There were no kinks or other damages noted prior to prep.There were also no damages or anomalies noted to the precise pro rx prior to removal from packaging, and no damages or anomalies were noted to the packaging.There was no difficulty experienced as the precise device was removed from the packaging; and the device was stored, inspected, handled and prepped according to the instructions for use (ifu).It is unknown if the hemostasis valve was in the open or closed position when received or if the valve was closed prior to removal from the tray.

Manufacturer Narrative

Complaint conclusion:   when pumping pressure, the user found the balloon of a aviator plus.014 5 x 30 mm 142 cm balloon catheter (bc) was leaking during negative pressure before insertion into the patient.Another cordis device was used to replace the aviator.After the user removed the 7 x 30 mm precise pro rx stent delivery system (sds) from the product packaging, the user found the stent was exposed.Another cordis stent was used to complete the procedure.There was no patient injury as the devices were not used in the patient.The intended procedure/target lesion was unknown.There were no difficulty removing the aviator balloon catheter from the hoop, balloon cover, or stylet.There were no kinks or other damages noted prior to prep.There were also no damages or anomalies noted to the precise pro rx prior to removal from packaging, and no damages or anomalies were noted to the packaging.There was no difficulty experienced as the precise device was removed from the packaging; and the device was stored, inspected, handled and prepped according to the instructions for use (ifu).It is unknown if the hemostasis valve was in the open or closed position when received or if the valve was closed prior to removal from the tray.        a non-sterile aviator plus.014 5.0 x 30 142 cm bc was returned.Per visual analysis, the balloon was partially deflated.No other anomalies were noted.Per functional analysis a.018¿ guide wire (lab sample) was inserted via the tip through the unit.Water was then applied to the catheter and the balloon successfully inflated.However, a leak was noted on shaft at 24.5 cm from the id band.  no other anomalies found.Per microscopic analysis a pinhole and abrasion marks adjacent to the pin hole were noted on the external surface of the shaft.Per sem analysis the external surface of the body revealed evidence of elongations and abrasion marks adjacent to the pinhole.These characteristics could be related to the interaction with an unknown source force that caused deformation until rupture of the outer body material.No other anomalies were found during the sem analysis.A device history record (dhr) review of lot 17524229 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 negative prep¿ and ¿body/shaft    puncture/cut¿ were confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the limited information available for review, vessel characteristics (although unknown) may have contributed to the event as evidenced by abrasions noted on the outer surface during analysis.The reported ¿stent delivery system (sds)-ses deployment difficulty - premature deployment¿ was not confirmed through analysis as the stent was not returned.The exact cause of the events could not be determined 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.¿ according to the instructions for use ¿slack removal: advance the stent delivery system past the lesion site.Pull back the stent delivery system until the radiopaque inner shaft markers (leading and trailing ends) move in position so that they are proximal and distal to the target lesion.Ensure the device outside the patient remains flat and straight.Caution: slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the lesion site.5.Stent deployment.Note: when ready to proceed with stent deployment, heparin may be administered per standard hospital practice or as prescribed by a physician.Heparin may be continued following stent deployment if so indicated by a physician or hospital protocol.Verify that the delivery system's radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion.Unlock the tuohy borst valve connecting the inner shaft and outer sheath of the delivery system.Ensure that the access sheath or guiding catheter does not move during deployment.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand.¿ 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 at this time.

• Brand Name: AVIATOR PLUS .014 5.0X30 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 ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6231350
• MDR Text Key: 64129032
• Report Number: 9616099-2017-00849
• Device Sequence Number: 1
• Product Code: LIT
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 4245030W
• Device Lot Number: 17524229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/15/2016
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1