MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 MPA-1 90CM; CATHETER, PERCUTANEOUS

Model Number 67027090

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.A device history record (dhr) review of lot 17707422 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

Event Description

As reported, a 6f.070 mpa-1 90cm vista brite tip guiding catheter was being used for a chronic total occlusion (cto), however, before reaching the lesion it could not advance anymore and the distal end became frayed.There was no reported patient injury.The doctor commented that the issue might have occurred with the lesion having heavy calcification and the device was pushed strongly.

Manufacturer Narrative

Complaint conclusion: as reported, a 6f.070 mpa-1 90cm vista brite tip guiding catheter was being used for a chronic total occlusion (cto), however, before reaching the lesion it could not advance anymore and the distal end became frayed.There was no reported patient injury.The doctor commented that the issue might have occurred with the lesion having heavy calcification and the device was pushed strongly.The device was not returned for analysis.A product history record (phr) review of lot 17707422 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 frayed/split/torn in patient¿ and ¿catheter (body/shaft) tracking difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause of the frayed condition could not be determined.Based on the information available for review, access site vessel characteristics (heavy calcification) and handling factors (pushed strongly) most likely contributed to the reported events.Difficulty tracking a product through an anatomical structure is a known procedural occurrence.This type of difficulty occurring during the clinical use of the device is usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient¿s anatomy, vessel characteristics, operator¿s technique and appropriate device selection.The instructions for use (ifu) cautions users to inspect for signs of damage prior to and during use.Any product with damage is not to be used.According to the ifu, which is not intended as a mitigation, ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .070 MPA-1 90CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8785273
• MDR Text Key: 150856126
• Report Number: 9616099-2019-03072
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032020968
• UDI-Public: 20705032020968
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 67027090
• Device Catalogue Number: 67027090
• Device Lot Number: 17707422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1