MAUDE Adverse Event Report: CORDIS CORPORATION 4F INF .038" 100CM WILLIAMS CU; DIAGNOSTIC CARDIOLOGY CATHETER

Catalog Number MODC18498

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

A device history record review of lot 17423275 was performed and showed that the lot met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported that the 4f infiniti.038" 100cm williams cu catheter "yellowish" distal tip came off and remained on the wire during prep.Another device was used and the procedure was completed successfully.There were no patient injuries.The user immediately placed the product on the side once it was noticed.Additional information was received and there were no anomalies to the package.No forced was used while advancing the guidewire through the device during prep.The tip came off when removing the wire that comes with the device.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: 4F INF .038" 100CM WILLIAMS CU
• Type of Device: DIAGNOSTIC CARDIOLOGY CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5893960
• MDR Text Key: 53671271
• Report Number: 9616099-2016-00536
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

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: MODC18498
• Device Lot Number: 17423275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1