MAUDE Adverse Event Report: CORDIS CORPORATION CATH 4F ST C2-A2 65CM; DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)

Catalog Number 532443

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

Product coming back but not yet received.Additional information will be submitted within 30 days of receipt.This is one of two products involved with this event in which associated manufacturer report numbers is 9616099-2015-00555.

Event Description

Two supertorque catheters did not have the yellow radiopaque tip and they looked like they are cut.They showed an incomplete ending curve.The procedure was completed by replacing the catheter with a new one.No consequence to the patient was reported.The products will be returned for analysis.Pictures have been received.

Manufacturer Narrative

Complaint conclusion: as reported, two supertorque catheters did not have the yellow radiopaque tip and they looked like they are cut.They showed an incomplete ending curve.The procedure was completed by replacing the catheters with a new one.No patient consequence was reported.Attempts to gather further information were unsuccessful.The products were not returned for analysis.Review of lot 16025932 revealed no anomalies during the manufacturing and inspection processes.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH 4F ST C2-A2 65CM
• Type of Device: DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)
• 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: 5222441
• MDR Text Key: 31190242
• Report Number: 9616099-2015-00556
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K914007
• 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: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 532443
• Device Lot Number: 16025932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Date Device Manufactured: 12/19/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1