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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray. Rpn: c-utlmy-701j-abrm-hc-ihi-fst-rd. (b)(4). The event is currently under investigation.

Event Description

(b)(4): new central venous line confirmed by x-ray as located in superior vena cava (vein). The (b)(6) year old patient with altered mental status approximately 4 days later leading to activation of code stroke. Cat scan reveals catheter is actually in the innominate artery and patient suffered watershed stroke in the anterior cerebral artery (aca) & middle cerebral artery (mca) territory. Line removed immediately. Additional information received on 09 may 2016: the patient is reported to have been in rehabilitation.

Manufacturer Narrative

(b)(4). Investigation/evaluation: during the course of the investigation, a review of the complaint history, device history record, instructions for use (ifu), and documentation of the product was conducted. 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. At this time the device appears to not have a malfunction related for this event; occur due to the procedure error. Our instructions for use (ifu) notates for its intended use, " continuous or intermittent drug infusions, central venous blood pressure monitoring (cvp), acute hyperalimentation, blood sampling, delivery of whole blood or blood products, and power injection of contrast media. " the device is shipped with an ifu that describes the intended use contraindications, warnings and precautions, and the correct deployment procedure. The ifu indicates the ¿device is a short-term use catheter¿ every effort must be made to ascertain proper tip position in order to prevent erosion or perforation of central venous system. Tip position should be verified by x-ray and monitored on a routine basis. Periodic lateral view x-ray is suggested to assess tip location in relation to vessel wall. Tip position should appear to be parallel to the vessel wall¿patient movement can cause catheter tip displacement. Use should be limited to controlled hospital situations. Use of ecg, ultrasound and/or fluoroscopy is suggested for accurate catheter placement. " we will continue to monitor for similar complaints and have notified the appropriate internal personnel. Per the risk assessment,no further action is required.

Event Description

As reported in the medsun report (b)(4): new central venous line confirmed by x-ray as located in superior vena cava (vein). The (b)(6) patient with altered mental status approximately 4 days later leading to activation of code stroke. Cat scan reveals catheter is actually in the innominate artery and patient suffered watershed stroke in the anterior cerebral artery (aca) & middle cerebral artery (mca) territory. Line removed immediately. Additional information received on 09 may 2016: the patient is reported to have been in rehabilitation.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5688079
• MDR Text Key: 46167467
• Report Number: 1820334-2016-00356
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002498020
• UDI-Public: (01)00827002498020(17)180731(10)6271915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/05/2016,05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2016
• Distributor Facility Aware Date: 03/25/2016
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/31/2016 Patient Sequence Number: 1