MAUDE Adverse Event Report: CORDIS DE MEXICO CATH F6 INF TL JL 3.5 100 CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17594672 presented no issues during the manufacturing process that can be related to the reported event.This device is not yet available for testing and evaluation.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported that prior to use, the user noticed that the distal curve of the catheter was kinked.When the user examined the affected zone of the catheter, it separated.There was no reported patient injury.The intended procedure was a cardiac catheterization.A new catheter was used to finish the procedure.

Manufacturer Narrative

It was reported that prior to use, the user noticed that the distal curve of the catheter was kinked.When the user examined the affected zone of the catheter, it separated.There was no reported patient injury.A new catheter was used to finish the cardiac catheterization procedure.The device was not returned for analysis.A device history record (dhr) review of lot 17594672 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) kinked/bent - prior to use¿ and ¿catheter (body/shaft) separated¿ could not be confirmed as the device was not returned for analysis.The exact cause of the kinked/bent and separated conditions could not be determined.Based on the limited information available for review, storage and/or handling factors likely contributed to the catheter kink and the separation reported as evidenced by the twisted and elongated damage noted at the separation site with transfer of material observed.According to the instructions for use (ifu), ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ 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 F6 INF TL JL 3.5 100 CM
• 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: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6546017
• MDR Text Key: 74489066
• Report Number: 9616099-2017-01076
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 534618T
• Device Lot Number: 17594672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/08/2017
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1