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

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Blood Loss (2597)

Event Date 08/19/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 0.035 guide wire, 5-fr kumpe catheter, 6-mm amplatzer vascular plug iv.(b)(6).Pma/510(k) number: exempt.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 in the european journal of cardio-thoracic surgery that a 14 fr cook thal-quick chest tube was inadvertently inserted through the hepatic vein and entered the right ventricle of the patient's heart.The patient was a (b)(6) with history of a malignant right pleural effusion.The patient had been diagnosed with t4n3m0 lung adenocarcinoma, and was admitted to the hospital with complaints of persistent cough after receiving chemoradiation therapy.The initial chest x-ray showed a large pleural effusion.A limited chest computed tomography (ct) taken 6 days earlier during radiotherapy showed the elevated right hemidiaphragm at the level of patient¿s nipples along with minimal pleural effusion.The healthcare professional placing the chest tube overlooked the ct.A 14 fr.Thal-quick chest tube was placed under ultrasonographic guidance using the seldinger method.During the procedure, the patient was stable initially, but became confused and suddenly collapsed.After detecting whether the 700ml of venous blood was drained, the catheter was clamped.Chest compressions were performed for four minutes until spontaneous circulation was restored.The patient was transferred to the intensive care unit (icu).After the patient had stabilized, contrast enhanced chest and abdomen ct scans were performed.The ct confirmed that the chest tube had entered the right ventricle through the inferior vena cava and hepatic vein.The device was retracted 5cm to locate the tip of the catheter at the inferior vena cava.The patient was monitored for 12 hours to assess the risk of major hepatic hemorrhage, abdominal injury and arrhythmia.No remarkable findings were present on the echocardiogram.Next the patient was sent to the intervention room.Through a thoracostomy drain tube, a guide wire was introduced, next a catheter was introduced over the guide wire.The track embolization was completed with a vascular plug through the catheter without periprocedural events.On postintervention day 26, the patient was discharged after receiving scheduled chemotherapy.Four months later, a follow-up ct scan showed a well-placed vascular plug intravenous.

Manufacturer Narrative

Additional information: event.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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

In additional information received on 24may2019, it was noted by the medical staff that the location of the patient's diaphragm was quite high compared to others, therefore, it was decided to access the upper intercostal rib rather than the normal routine.The case was performed by a third year resident.As reported, the resident, "used the product in a specific order, so no one could have anticipated the problem that occurred." the physician noted that a general complication of thoracostomy procedures could be a puncture or injuries to patient's lungs incident to malposition of the tube or a phase in the procedure.This is why the medical staff that was involved in the treatment thought that the misplaced tube in the heart through the hepatic vein via the inferior vena cava was a really rare case.The event is not thought to have been caused by the product "because the products were being used well to perform other thoracostomy cases at the same time".Imaging from the event will not be provided.The hospital does not allow any information regarding the patient to be taken by anyone outside of the facility, as per hospital and government policies.Air was aspirated from the introducer needle before the guidewire and catheter were inserted.The procedure seemed to have been successful, as no issues arose with the product.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation a review of the documentation including the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned, therefore a visual inspection of the complaint device could not be completed.The lot number of the device was unknown and could not be narrowed down, therefore representative devices could not be searched for.Based on the known information, there is no evidence to suggest the device was not manufactured within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.It was concluded that sufficient controls are in place to identify and prevent this failure mode prior to lot release.Analysis of the design history file indicated that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record could not be completed due to a lack of information provided in the journal article.A search for additional reported complaints could not be completed due to the unknown lot number.With the known information, there is no evidence to suggest nonconforming product exists in house or out in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: "the centimeter markings on the chest tube denote the distance from the most proximal side port¿these markings can be used as a reference while establishing appropriate device positioning." precautions: "manipulation of products requires fluoroscopic, ct scan or ultrasound guidance." the instructions further describe all steps that should be taken to properly place the chest tube.It states multiple times that it is important that all sideports of the chest tube are positioned within the pleural space.Based on the information provided, no returned product and the results of the investigation, a definitive cause was established as user technique and unintended use error.The journal article confirms that the procedural complications were due to the misplacement of the device, but also confirmed that imaging was used during placement.It is possible that the misplacement was caused by over insertion of the needle or dilator, therefore causing misplacement of the catheter.It is also possible that the centimeter markings on the chest tube were not adequately used during placement, as these markings are to be used as a reference for correct placement of the tube.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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 the patient or event has been received since the previous medwatch report was sent.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8627986
• MDR Text Key: 145646628
• Report Number: 1820334-2019-01235
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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-1400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR