MAUDE Adverse Event Report: COOK INC UNKNOWN; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Occlusion Within Device (1423); Sticking (1597)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Customer reports a generalized dissatisfaction with various cook spectrum micocycline/rifampin impregnated triple lumen central venous catheters.Physician indicates venous thrombosis as the primary reason for dissatisfaction.No further patient, event or product details were provided.It is opined that the device was explanted as a result of thrombosis.Further investigation into this report is in progress.

Manufacturer Narrative

Device name rpn: c-sdlmy-401j-ped-abrm-fst.Investigation ¿ evaluation: a review of the complaint history, documentation, instructions for use (ifu), manufacturing instructions, quality control, and trends of the device was conducted during the investigation.The two antibiotics that are used on these devices are rifampin and minocycline.These two antibiotics help reduce catheter related infections for the catheter indicated use of >30 days.Catheters are manufactured through an impregnation process where the drugs are absorbed into the catheter polymer.The instruction for use (fu) also goes over standard flushing procedure and filling of lumens with heparinized saline solution to prevent clotting or embolus prior to catheter insertion.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.

Event Description

After further review of the record, it was determined the patient device was not explanted.The patient received lovenox i dosing twice a day to treat the thrombosis.The customer alleged the catheters are sticky, which may increase the potential for the patient to develop a venous thrombosis.The patient had a central venous catheter insertion procedure (internal jugular).

• Brand Name: UNKNOWN
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6525376
• MDR Text Key: 73801635
• Report Number: 1820334-2017-00886
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention