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

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 11/04/2017

Event Type  Death  

Manufacturer Narrative

Pma/510(k) # exempt.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The international customer reported, the patient was 24 weeks gestational age at birth due to pre-term labor.Apgar scores were reportedly 7 and 7.The patient had respiratory distress syndrome and was on continuous positive airway pressure (cpap), and by day 2 had left sided pulmonary atelectasis of both lobes and as well as the right lower lobe.The decision was made to give surfactant via the insure method however, the patient after intubation wouldn¿t breathe well enough to be extubated.Imaging determined a chest tube was indicated for treatment of a right side pneumothorax.When the user facility opened the thal-quick chest tube set, they noticed the introducer needle was quite long for an 8 french chest tube.The physician instructed the fellow in training to only insert the needle to a 1 cm to 1 1/2 cm length; however, the needle was put in about 2/3 of its length.The placement of the needle was confirmed with the use of a syringe attached to the needle.Upon placement of the chest tube, the patient lost their heart rate, and 49 ml of blood went through the chest tube.The staff attempted a full resuscitation, normal saline bolus of 20 ml/kg, bolus epinephrine x 2, called for blood to give as a fluid expander but it did not arrive in time.The patient expired.No autopsy was performed.According to the physician, the needle included in the set was the correct length (5cm), however, too long for the patient.The complaint product lot number is unknown and the device is unavailable for return.

Manufacturer Narrative

Blank fields on this form indicate the information is previously submitted, unknown, or unavailable.Investigation ¿ evaluation: a review of the complaint history, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications was conducted during the investigation, and no issues were found related to the reported issue.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The device is shipped with instruction for use (ifu) which notes: warning: ¿over insertion of the needle and/or dilators may result in serious harm to the patient.¿ precautions: ¿this product is intended for use by physicians trained and experienced in percutaneous pleural drainage techniques.Standard techniques for placement of chest tubes should be employed.Manipulation of products requires fluoroscopic, ct scan or ultrasound guidance.¿ instructions for use: ¿advance the introducer needle over the superior border of the rib and into the pleural space.Fluid or air should be aspirated to verify an intrapleural position.¿ 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.¿ the thal-quick chest tubes are not specifically indicated or contraindicated for patients of a certain age group or size.Follow-up with the customer confirmed that the user did not use imaging while placing the device and an ifu was provided with the product.From the customer's testimony it was concluded the cause of death to be blood loss form a penetrating visceral or vascular injury as a consequence of the needle over insertion.Based on the information provided, no product returned, and the results of our investigation, the cause was determined to be user error.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7104706
• MDR Text Key: 94408741
• Report Number: 1820334-2017-04161
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• 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
• Patient Age: 2 DA
• Patient Weight: 1