MAUDE Adverse Event Report: COOK INC THAL-QUICK CHEST TUBE SET; GBX CATHETER, IRRIGATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemothorax (1896)

Event Date 01/01/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The 510k status: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The following adverse event was reported in a journal article.A (b)(6) male was referred to a tertiary referral center for the treatment of respiratory failure due to legionella pneumonia.The urine antigen tests for legionella were positive, while aerobic and anaerobic cultures remained negative, after which the patient was started on ciprofloxacin 400 mg twice daily doses adapted to their kidney function, and ceftriaxone 2000 mg once daily.Because of increasingly difficult ventilation, the patient was transferred to the intensive care unit (icu) and intubated.Even ventilating in the prone position didn¿t improve the patient's situation, and the patient was transferred to another facility for the placement of veno-venous extracorporeal membrane oxygenation (vv-ecmo).Due to a pneumothorax shortly before transfer, a chest-tube was placed in the referring hospital.At the receiving facility, swift and uncomplicated cannulation of the right jugular and right femoral vein was performed in the icu.After this procedure, the receiving facility started with vv-ecmo at 5 liter/minute blood flow, 6 liter/minute sweep gas flow and at a rate of 2975 revolutions per minute.Cultures were taken, and the antibiotic regime was changed to levofloxacin 500 mg intravenous (i.V.) once daily adapted to the patient's reduced kidney function, cefotaxime 1000 mg i.V.Four times daily, and selective digestive decontamination (sdd).Patient had already been started on continuous renal replacement therapy (crrt).During the first hours, the patient developed a second ipsilateral hemothorax that was not sufficiently drained by the first chest-tube, as it had become dislocated; this necessitated the placement of a second one, using a seldinger technique.The latter produced no fluid, and the patient became hemodynamically unstable, which necessitated the urgent placement of the third chest tube, which was the complaint device.The release of 300 ml of blood directly followed the placement of the device, and emergency computed tomography angiography (cta) was then performed.At that moment, there was a hemoglobin value of 4.2 mmol/l, with ongoing transfusion of erythrocytes.After cannulation, the facility had omitted the use of heparin, fearing bleeding complications.Cta of the thorax demonstrated contrast extravasation at distal end of the last chest tube.The blush was likely to come from a sub-segmental pulmonary artery branch of the upper lung segment artery.This strongly suggested that the last chest-tube had caused the bleeding.Following this, the patient underwent an angiography and coiling procedure.Interestingly, the contrast fluid stopped draining from the chest-tube after the coiling procedure.The next day, the patient was taken to the theater for surgical evacuation of retained blood clots, during which procedure minor additional bleeding was corrected.Unfortunately, the bleeding continued despite adequate blood product supplementation.Cardiac arrest interrupted transportation for a repeat surgical intervention, and proved irreversible.The patient expired.The second and third chest-tube placements by seldinger technique reportedly had aggravated bleeding, necessitating further intervention.The facility reportedly believed that the relationship between the second and third chest tubes (the complaint devices) and the bleeding was not clear, but a correlation between tip of the complaint devices and the local injury which resulted was made by the facility.The manufacturer of the first chest tube was not provided.The ultimate findings of the article were that patients receiving ecmo are more vulnerable to developing a hemothorax, and that in this particular patient, the minimal invasiveness of the placement technique did not lower the patient's bleeding risk.The complaint devices are reportedly unavailable for return and evaluation.

Manufacturer Narrative

Investigation - evaluation.A review of the drawings, documentation, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.The product drawing shows that there are markings and measurements printed along the chest tube in order for the physician to determine how far the tube has been inserted into the patient.Document review also identified proper procedures for identifying/preventing any manufacturing issues which could contribute to this failure mode.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.However, a report of all c-tqts-1600 shipments to the user facility was conducted and identified 11 shipments of this device between 01jan2015 and 06dec2018.Due to this we determined that the customer received one of the two following instruction for use (ifu) documents: c_t_thal_rev8 or c_t_thal_rev9.Both ifu's provide figures which show the proper way to insert the wire guide and chest tube into the pleural space, in addition to stating the following: "precaution: manipulation of products requires fluoroscopic, ct scan or ultrasound guidance." "warning: over insertion of the needle and/or dilators may result in serious harm to the patient." "note: the needle should be introduced and directed with appropriate orientation inferiorly or superiorly." "note: due to anatomical variations in chest wall thickness, insertion depth of introducer needle, wire guide and dilators will vary from patient to patient." "note: it is important to have enough length of wire guide exiting the access site to facilitate controlled introduction of the dilators.The dilators only have to enter the pleural space to their full diameter and should never be advanced beyond the distal end of the wire guide." "note: if resistance is encountered during chest tube assembly insertion, determine the cause of resistance and take necessary action to relieve resistance before proceeding." "note: the distal end of the chest tube inserter should not be advanced beyond the distal end of the wire guide." after further investigation of the reported procedure, the manufacturer believes that the reported failure was due to the insertion of the second chest tube and not the third.It is believed that the tube was inserted into the wrong location which would explain why this chest tube was unable to produce any fluid.In addition, this would have caused the excessive bleeding and explain why the patient became hemodynamically unstable.Furthermore, it was stated that the third tube released ¿old blood,¿ which can also be explained by the second tube causing the bleeding.When looking at figure 1, it shows the excess bleeding to be located away from the distal tip of the chest tube (third tube).This gives more evidence that the bleeding was caused by the second tube.It is believed that the tip of the second tube was inserted into the bleeding location, removed, and then the tip of the third tube was inserted past the bleeding to where it is shown in figure 1.Lastly, the ifu states, ¿manipulation of products requires fluoroscopic, ct scan or ultrasound guidance.¿ there is no report of imaging being used, however the manufacturer highly recommends the use of imaging in order to better place the device and avoid excessive bleeding.Document review was conducted and identified the proper procedures for identifying/preventing any manufacturing issues which could contribute to this failure mode.Therefore, the root cause is possibly product use; not following ifu.This complaint has been confirmed due to the journal entry and will be trended as adverse physiological response.Due diligence has been conducted and unsuccessful when trying to gain additional information on whether medical images was used for chest tube placement.The journal entry does not define whether imaging was used, however it does mention that, "there is an inability to digitally manipulate the pleural space." unless additional information is provided via customer, the root cause will be determined as product use because the ifu states that medical imaging must be used for device placement.A review of work orders, similar complaints, and non-conformances could not be conducted due to the lot number not being provided.We will continue to monitor for similar complaints.Measures have been previously initiated to address this failure mode.Per quality engineering risk assessment, there are no further actions required at this time.

Event Description

Several attempts by the manufacturer clinical support representative were performed to obtain additional information, no additional event information has been made available as of the date of this report.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7487849
• MDR Text Key: 107383898
• Report Number: 1820334-2018-01394
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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-TQTS-1600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 69 YR