MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN HEPARIN COATED CENTRAL VENOUS CATHETER TRAY; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

It was reported that the guide wire doesn't fit through the lumen.This problem happened with two patients (patient #1 1820334-2016-01565; patient #2 1820334-2016-01599) in cardiac theaters.In both patients, the needle was placed into the jugular under ultrasound, then the wire was fed through into the jugular.When the central venous catheter (cvc) was railroaded over the wire it got stuck and did not advance into the jugular.They then opened another kit to repeat the process and the same fault occurred.This happened twice in each theatre so four kits were used, same lot number, same product.They then tried another cvc line, from a different lot number that was also longer and it was placed with no issue.Both patients had an increased need for antibiotics.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the documentation, instructions for use (ifu), device history record, drawing, manufacturing instructions, dimensional verification, quality control data, visual inspection, and functional testing was conducted during the investigation.The triple lumen heparin coated central venous catheter trays for mfr # 1820334-2016-01565 and mfr # 1820334-2016-01599 were returned together and cannot be distinguished.Along with the two catheters, two wire guides and a dilator were returned.The wire guide was noted to be kinked, and one wire guide was bent 2 cm from the proximal end.The devices were in used condition.Dimensional inspection found the wire guide outer diameter, sheath outer diameter, and sheath taper length for all devices were within specifications.However, functional testing by advancing the wire guides through the catheters experienced some difficulty in initial insertion.In both cases, a snag could be felt in the taper; however, if pushed past this snag, the wires were able to be advanced.A blood clot was dislodged from one of the catheters as a result.It is feasible to suggest that the snag in the tapers prevented the catheter from advancing in the complaint event.Review of the device history record of the finished product shows one nonconformance that would contribute to this failure mode.There was one other reported complaint for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that the guide wire doesn't fit through the lumen.This problem happened with two patients (patient #1 1820334-2016-01565; patient #2 1820334-2016-01599) in cardiac theaters.In both patients, the needle was placed into the jugular under ultrasound, then the wire was fed through into the jugular.When the central venous catheter (cvc) was railroaded over the wire it got stuck and did not advance into the jugular.They then opened another kit to repeat the process and the same fault occurred.This happened twice in each theatre so four kits were used, same lot number, same product.They then tried another central venous catheter line, from a different lot number that was also longer and it was placed with no issue.Both patients had an increased need for antibiotics and anti-inflammatory medication.

• Brand Name: TRIPLE LUMEN HEPARIN COATED CENTRAL VENOUS CATHETER TRAY
• 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: 6208414
• MDR Text Key: 63379355
• Report Number: 1820334-2016-01599
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002506985
• UDI-Public: (01)00827002506985(17)170923(10)7252432
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• 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: C-UTLM-501J-25-6.5-WCE-BH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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 Age: 11 MO