MAUDE Adverse Event Report: COOK INC HEAVY DUTY DOUBLE FLEXIBLE TIPPED WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
A cook medical heavy double flexible tipped wire guide was placed and needle withdrawn.The dilator was placed and removed.A 7 french 3x lumen catheter was inserted.Blood returned from all ports.Chest x-ray identified that wire guide was fractured and there was a retained segment of the wire guide.There was an additional procedure to remove the retained segment of the wire guide.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation, a review of the documentation, quality control, instructions for use (ifu), manufacturing instructions, drawing, specifications, and trends of the product was conducted.The device was not returned to assist in the investigation.There is no evidence to suggest the product was not manufactured to current specifications.Based on the description of the event, it was possible that manipulation of the wire by the end user was performed prior to patient contact.In addition, the information provided and the characteristics displayed it was plausible to suggest that this incident was technique related and not the fault of the device in question.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a routine exchange of right internal jugular central venous catheter for continuous venous hemofiltration, a heavy double flexible tipped wire guide was placed and the needle withdrawn.The dilator was placed and removed.A 7 french 3x lumen catheter was inserted.Blood returned from all ports.A chest x-ray identified that wire guide was fractured and there was a retained segment of the wire guide.There was an additional procedure to remove the retained segment of the wire guide.

• Brand Name: HEAVY DUTY DOUBLE FLEXIBLE TIPPED WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5787911
• Report Number: 1820334-2016-00572
• Device Sequence Number: 652221
• Product Code: DXQ
• UDI-Device Identifier: 00827002497467
• UDI-Public: (01)00827002497467(17)151001(10)3647839
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HDOC-32-60-0-2.5-HTS-MWG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR