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

Catalog Number C-TQTS-2400

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

Patient Problems Injury (2348); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient suffered a heart injury but there were no significant complications and the patient has been discharged.At this time, it is unknown as to what interventions were necessary.Additional information has been requested.Event occurred sometime in (b)(6), approximately 4 weeks prior to (b)(6) 2019.(b)(6).Pma/510k: 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 during a thoracic drainage procedure at the university hospital (b)(6) that a patient suffered a heart injury during placement of a thal-quick chest tube set.The date of event is unknown but it happened approximately 4 weeks prior to (b)(6) 2019."there were no significant complications and the patient has already been discharged from hospital." additional information has been requested but is currently unavailable.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), quality control and specifications 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.Cook has concluded that sufficient controls are in place to identify the failure mode prior to lot release.There is no evidence to suggest that the device was not manufactured to specification.Proper risk controls are in place to prevent these failure modes prior to release.The risk analysis indicates that the risks associated with the devices are acceptable when weighed against the benefits.The exact device history record (dhr) for the complaint device could not be completed due to a lack of lot information from the user facility.A sales search of the devices provided six potential lots (8773096, 8644684, 8653529, 8843986, 9553164, and 9728963) that could have included the complaint device.Two related non-conformances were reported for subassembly lots within lots 8653529 and 9728963 for incorrect needle and catheter lengths.All nonconforming product was identified and scrapped out or reworked prior to the lot releases.No other related non-conformances were reported for any of the potential lots.A database search found no other reported complaints for the six reviewed potential lots.As adequate inspection activities are in place, all related nonconforming devices were identified and scrapped out prior to lot release, and no other complaints have been received from the field for the potential lots, there is no evidence to suggest there is any nonconforming product in house or in field.Cook also reviewed the product labeling for the device.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: "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: "4.Advance the introducer needle over the superior border of the rub 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.5.When the appropriate drainage site has been identified, advance the soft "j" end of the wire guide through the needle and into the pleural space.Note: the wire guide should pass through the needle and advance into the pleural space without resistance.Note: the skin level marker on the distal end of the wire guide can be used as an insertion depth marker on patients with normal anatomy.Note: due to anatomical variations in chest wall thickness, insertion depth of introducer needle, wire guide and dilators will vary from patient to patient.6.Remove the needle, leaving the wire guide in place.7.Liberally inject additional local anesthetic into the intercostal muscles surrounding the wire guide.8.While maintaining the wire guide position, dilate the tract and opening into the pleural space by advancing, in sequence small to large, the supplied dilators over the wire guide.Introduction into the pleural space is facilitated by rotating and advancing the dilators in line with the wire guide to prevent its kinking.Warning: over insertion of the needle and/or dilators may result in serious harm to the 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.9.With the wire guide still positioned within the pleural space, advance the chest tube inserter/chest tube assembly over the wire guide and into the pleural space.Note: if resistance is encountered during chest tube assembly insertion, determine the cause of the resistance and take necessary action to relieve resistance before proceeding.Note: it is important to advance the chest tube assembly into the pleural space in the same line as the wire guide.This will made introduction easier and avoid kinking of the wire guide.Note: the distal end of the chest tube inserter should not be advanced beyond the distal end of the wire guide." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." the complaint was able to be confirmed based on customer testimony.Based on the information provided, no product returned, and the results of our investigation, a possible root cause was determined to be an adverse event related to the procedure and cannot be traced to the device.It is possible that the chest drain was over-inserted, leading to the heart injury.The ifu warns about over-insertion of the components, and states to use imaging during placement ad manipulation.It is also possible that other unknown issues during the procedure, or with the patient anatomy led to the occurrence.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 new event description information to report at this time.

• 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: 8960166
• MDR Text Key: 156464426
• Report Number: 1820334-2019-02215
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-TQTS-2400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other