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

Model Number	67027090
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8785273
• Report Number: 9616099-2019-03072
• Device Sequence Number: 13962798
• Product Code: DQY
• UDI-Device Identifier: 20705032020968
• UDI-Public: 20705032020968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1