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

Model Number	G44128
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6872132
• Report Number: 1820334-2017-03077
• Device Sequence Number: 4204462
• Product Code: FOZ
• UDI-Device Identifier: 00827002441286
• UDI-Public: (01)00827002441286(17)190401(10)7354173
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G44128
• Device Catalogue Number: C-UTLMY-701J-RSC-ABRM-HC-FST-A-RD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/18/2017
• 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: Life Threatening