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

Model Number G44128

Device Problems Bent (1059); Coiled (1098); Kinked (1339); Failure to Advance (2524)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

Brand name- cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.Rpn- c-utlmy-701j-rsc-abrm-hc-fst-a-rd.(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

During an attempt to insert a central venous catheter into the femoral vein, difficulty was encountered with the wire kinking, bending and coiling, inhibiting the passage of the catheter.The procedure was being performed on an elderly male patient that was in shock, requiring vasopressors.The procedure was performed by a pulmonary fellow under the supervision of an attending physician.Ultrasound of the area did not indicate any deviations in the patient¿s anatomy both proximal and distal to the insertion site.The needle was inserted without issue under ultrasound guidance; the wire was advanced to the lower 1/3 of the superior vena cava.The needle was removed and a small skin nick was made on both sides of the wire.The dilator was inserted over the wire and it is unclear if there was any issue inserting the dilator.At some point in the dilation, the fellow described the wire as going slack or losing rigidity.The dilator was removed and the catheter was inserted over the wire.At this point the catheter did not advance as expected.The fellow removed the catheter and the wire.It was noted that there was a "huge" kink in the proximal end of the wire approximately at the distance of the tip of the dilator.The fellow opened up another manufacturer¿s cvc kit and performed a femoral central line insertion on the contralateral side.There were no issues with this insertion.The physician described the event as rare.It was also mentioned that the guidewires were kinking, bending and coiling and they are unable to advance the catheter over the guide wire.¿multiple failed attempts at placing femoral central and arterial lines by vastly experienced specialists in the micu¿.Specific details were not provided.

• Brand Name: COOK SPECTRUM
• 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 ; 8128294891
• MDR Report Key: 6872132
• MDR Text Key: 241266579
• Report Number: 1820334-2017-03077
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002441286
• UDI-Public: (01)00827002441286(17)190401(10)7354173
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G44128
• Device Catalogue Number: C-UTLMY-701J-RSC-ABRM-HC-FST-A-RD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening