MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6INF TL 3DRC 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534676T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Before use, the tip of the 6f infiniti catheter was not attached and was hanging by a piece of plastic.There was no patient injury.
Additional Manufacturer Narrative
Additional information was received.Before use, the tip of the 6f infiniti catheter was not attached and was hanging by a piece of plastic.There was no patient injury.The device was stored and handled according to the instruction for use (ifu).There were no kinks observed on the device.The device will not be returned for analysis.
Additional Manufacturer Narrative
Before use, the tip of a 6f infiniti catheter was not fully attached, it was hanging by a piece of plastic.There was no patient injury as the device was not used.The device was stored and handled according to the instructions for use (ifu).There were no kinks observed on the device.This device was not returned for analysis.A review of the manufacturing documentation associated with lot 17714545 was performed and no issues were noted that were considered potentially related to the reported event.The phr review does not suggest that the issue experienced by the customer could be related to the manufacturing process.The reported ¿brite tip/distal tip ¿ catheters cracked - during prep¿ could not be confirmed as the device was not returned for analysis.Storage and handling factors may have contributed to the event, as stated in the precautions in the ifu, ¿do not use if package is open or damaged.Exposure to temperatures above 54 degrees c (130 degrees f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ the phr review does not suggest that the issue experienced is related to the manufacturing process; therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH F6INF TL 3DRC 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7487688
• Report Number: 9616099-2018-02109
• Device Sequence Number: 1769076
• Product Code: DQO
• UDI-Device Identifier: 20705032014486
• UDI-Public: 20705032014486
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2018

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: 08/31/2020
• Device Model Number: 534676T
• Device Catalogue Number: 534676T
• Device Lot Number: 17714545
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/05/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/16/2018; 05/16/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 05/15/2018; 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1