MAUDE Adverse Event Report: CORDIS DE MEXICO CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451404V5

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported that during an endovascular procedure, the catheter tip broke off inside the patient.The tip was retrieved with a snare.The reason for the procedure were venous ulcers of both extremities.

Manufacturer Narrative

It was reported that during an endovascular procedure, the catheter tip broke off inside the patient.The reason for the procedure were venous ulcers of both extremities.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There were no anomalies noted during or after the device was prepped.The device was not inserted through a stopcock instead of a hemostatic valve.Resistance was felt advancing the product to the lesion, however it was said to be ¿normal resistance during a chronic total occlusion (cto)¿.  there was no unusual force used at any time during the procedure.The tip was visible on fluoro throughout the procedure.There was no device kink in the area of separation.The tip was retrieved with a snare. there was no difficulty removing the device from either the patient, the vessel or through another device.The patient was brought back in at another time to complete the procedure.The device was not returned for analysis.A device history record (dhr) review of lot 17511516 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip separated - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, it is not possible to determine any contributing factors to the issue reported.The product instructions for use caution users to grasp the hub and withdraw the catheter carefully during removal from the package to prevent damage to the catheter tip.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: CATH TEMPO 4F UF 65CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 6203716
• MDR Text Key: 63257407
• Report Number: 9616099-2016-00816
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2016
• 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 Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 17511516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/30/2016
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2016
• 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