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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Device name: 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 a split occurred in the extension lumen of a cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set.The catheter was already in place in the internal jugular vein (ij).A ct scan was being performed, and when contrast was being inserted by pressure injection into the distal lumen of the catheter at 3.5cc/sec, the patient began screaming as contrast fluid was "going all over her face" while in the ct machine.The nursing staff automatically went to the patient and noticed fluid "everywhere".It was then that a split was noticed in the extension tubing of the red distal lumen.The nursing staff clamped the extension lumen as low as possible to the hub, with another clamp placed on the catheter after the hub.There was a small kink in the catheter already due to the position of the catheter in the neck area; however, prior to inserting contrast, they could easily aspirate and flush the lumen.This lead them to believe that it would be okay to insert contrast under pressure.Once the catheter was clamped and the patient was sent back to the ward, the catheter was removed.The patient did not suffer any adverse effects or reactions.A catheter from another manufacturer was inserted on (b)(6) 2021.The current technique at the facility is to insert the catheter in a downward motion from the neck to the heart, which means that extra catheter remains outside the body in a curved manner and is taped so the extension tubing is facing downward.The insertion site is low on the neck, where the neck meets the shoulder.It was reported that the facility has been using this technique at the same insertion site for years and have never had any issues.It was suggested by the area rep to try a 15cm catheter so no catheter remains outside of the body.Additional information regarding event and device details has been requested, but is currently unavailable.

Manufacturer Narrative

Investigation ¿ evaluation: an issue was reported with a cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd-au) from an unknown lot.While contrast was being inserted into the device, a split was noted in an extension tube and contrast was leaking.The device was removed and replaced.Cook became aware of this event on 01mar2021 upon being notified by st vincent public hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of the documentation including the drawing, instructions for use (ifu) and quality control, as well as a visual inspection and functional test of the returned product was conducted during the investigation.One triple-lumen central venous catheter was received in a used and damaged condition.A longitudinal split was noted along the tubing of extension number one with the red hub.A functional test confirmed leakage at extension tube one, with no leakage found in the other two.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) could not be completed due to the lack of lot information from the facility.The product¿s design history file (dhf) was reviewed, and the risks associated with this device were acceptable when weighed against the benefits.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: intended use power injection of contrast media.The flow rate may not exceed 10 ml/sec.Warnings: the safe and effective use of central venous catheters with power injector pressures (safety cut-off) set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit of 10 ml/sec.To safely use catheters with a power injector, the technician/health care professional must verify prior to use that the maximum safety cut-off pressure limit is set at or below 325 psi and that the maximum flow rate is at or below 10 ml/sec.Do not exceed the maximum flow rate of 10 ml/sec.Exceeding the maximum flow rate of 10 ml/sec may result in catheter failure and/or catheter tip displacement.The information provided upon review of the dmr, ifu, dhr, dhf, and returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiency contributed to the event.It is possible that excessive pressure during power injection contributed to the extension tube crack, but this cannot be confirmed without additional information regarding the procedure.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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 patient and/or event details 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: 11505691
• MDR Text Key: 250995566
• Report Number: 1820334-2021-00953
• 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: 02/11/2022

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?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ARROW CVC
• Patient Outcome(s): Required Intervention
• Patient Sex: Female