MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F VER 135 DEGREE 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451414H0

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the ¿aspiration was clogged¿.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.There was no difficulty in pressing the device.There were no kinks/bends noticed in the device.The blockage was noted when the device was inside the patient.It was reported that the malfunction was not caused by a blockage of possibly injectable material, foreign material or clotting from the patient.Additional procedural details were requested but are unknown.One non-sterile unit from product cath tempo 4f ver 135 degree 100 cm was received coiled inside of a plastic bag.No anomalies or damages were observed on the received unit.An emerald.038¿ guide wire lab sample was inserted through the received catheter; the guide wire was advancing by the catheters hub when a strong resistance was felt at 18.2 cm from the hub.The catheter was sectioned near the location of resistance and by using the guide wire, dried blood accumulation was forced out of the catheter.A device history record (dhr) review of lot 17418953 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The failure ¿catheter (body/shaft) ¿ obstructed ¿ in patient¿ was confirmed through analysis of the returned device.The cause of the reported obstruction was due to the accumulation of dried blood in the catheter lumen.The exact cause of this blood accumulation could not be conclusively determined.Based on the limited information available for review, patient and/or procedural factors may have contributed to the reported blood clot in the catheter.According to the ifu, which is not intended as a mitigation, ¿before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the design or manufacturing process.Therefore, no corrective/preventive action will be taken.

Event Description

It was reported that the ¿aspiration was clogged¿.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The device was prepped per the instructions for use (ifu).There was no difficulty in pressing the device.There were no kinks/bends noticed in the device.The blockage was noted when the device was inside the patient.The malfunction was not caused by a blockage of possibly injectable material, foreign material or clotting from the patient.Additional procedural details were requested but are unknown.

• Brand Name: CATH TEMPO 4F VER 135 DEGREE 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; juarez FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6674217
• MDR Text Key: 78674997
• Report Number: 9616099-2017-01201
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/28/2017

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: 01/31/2019
• Device Catalogue Number: 451414H0
• Device Lot Number: 17418953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/16/2017
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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