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

Model Number N/A

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The date of the event is currently unknown, however, this event was reported to have happened within the last two weeks.Cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set.Product is not for sale in the united states.However, information was chosen for a same/similar device that is sold in the united states.Customer (person): (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that kinking between the insertion site and the hub of a cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter caused blockage of one of the lumens.Twenty centimeters of the central venous catheter was inserted into the internal jugular vein (ij) of the patient.The insertion was described as being located in the lower part of the neck, where the neck meets the shoulder.A few centimeters of catheter remains outside of the body, as the catheter is angled so the extension lumens face downwards.A clear dressing tape is put over the whole area to keep it in place.These insertions are predominantly done in "recovery" or in "the theatre".If a patient is too sick to travel, then the insertion will take place in the ward.Once the patient was returned to the ward, nursing staff noticed a kink in the catheter where it has been angled between the insertion site and the hub.It is believed that patient head movement caused the kink.At times, these kinks have lead to the blockage of the lumens.Attempts to manipulate and unkink the catheter are made, and if this is not possible, the remaining unblocked lumens are used.If the patient requires the use of all three lumens for treatment, the device is removed and replaced.The hospital's policy is to also use two anchor points so they always use the msw at the insertion site and suture at the winged hub at the end of the catheter.Cvc placements are completed by experienced inserters.This has occurred with six separate patient insertions at this facility.This report references one patient who did not require cvc replacement.Other related instances are referenced in reports with patient identifiers: (b)(6).Additional information regarding device details has been requested, but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation on (b)(6) 2021, st vincent public hospital reported to cook that a portion of extension tubing on a cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set (rpn: c-utlm-701j-rsc-abrm-hc-rd-au) kinked between the movable suture wing and the hub, blocking the tubing.The catheter was manipulated to try to remove the kink, but if that was not possible, the remaining lumens were used instead.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.Even though a sales shipment search was conducted, cook was unable to identify the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_ctulmabrmau_rev1 [cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿precautions ¿ patient movement can cause catheter tip displacement.Use should be limited to controlled hospital situations.Catheters placed from either a jugular or subclavian vein have demonstrated forward tip movement of 1-3 cm with neck and shoulder motion.Suggested catheter maintenance ¿ after catheter is place and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If venous blood is not freely aspirated, physician should immediately reevaluate catheter tip position.Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.How supplied upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of our investigation, a potential root cause has not been traced to the device, but rather to unintended use error.The customer stated that the catheter was inserted in the patient's internal jugular vein and then taped so that the hubs faced away from the patient's hair.This configuration may result in a higher probability of bending of the extension tubing, especially when simultaneously factoring in patient movement, potentially contributing to the reported event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11506010
• MDR Text Key: 240421618
• Report Number: 1820334-2021-00957
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD-AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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