MAUDE Adverse Event Report: COOK INC ARNDT ENDOBRONCHIAL BLOCKER SET; CBI TUBE, TRACHEAL/BRONCHIAL

Model Number N/A

Device Problems Deflation Problem (1149); Inflation Problem (1310); Leak/Splash (1354)

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

Event Type  Injury  

Manufacturer Narrative

Date of event: between 2007 and 2013.Pma/510(k) #: k160542.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 literature "anesthetic management of thoracoscopic resection of lung lesions in small children" that the balloon of an arndt endobronchial blocker set leaked during elective video-assisted thoracoscopic surgery for congenital pulmonary lesion(s).This literature retrospectively investigates the use of extraluminal bronchial blocker placement to achieve one-lung ventilation and the effect of remifentanil infusion to infants/small children who are undergoing video-assisted thoracoscopic surgery.The purpose of the literature is to describe their anesthetic experience with video-assisted thoracoscopic resection of congenital lung malformations in patients aging from 3-months-old to 5-years-old with emphasis on the one-lung ventilation technique and remifentanil use.The authors ultimately conclude that extraluminal parallel blocker use in young children undergoing thoracoscopic excision of congenital pulmonary lesions was effective, and that infusion of remifentanil effectively reduced surgical stress.This report with focus on patient 21.The procedure was performed under general anesthesia.Anesthesia was induced via either inhalation with sevoflurane or intravenously with propofol and atracurium was administered.Standard monitoring, including electrocardiogram, pulse oximetry (spo2), and noninvasive blood pressure plus invasive arterial blood pressure, was utilized.An uncuffed endotracheal tube was inserted into the left main bronchus.Once correct tube placement was confirmed by auscultation, it was used to position the arndt endobronchial blocker.Once the arndt endobronchial blocker was placed in the left main bronchus, the initial endotracheal tube was "pulled out to" the proximal end of the bronchial blocker.A 4.5 mm microcuffed endotracheal tube was inserted into the trachea and secured.A flexible fiberoptic bronchoscope was advanced to "confirm the correct position of the endotracheal and bronchial tubes, as well as to visualize the volumes of air needed to produce an adequate seal following bronchial balloon inflation".Following removal of the bronchoscope, the bronchial blocker was taped to the face and the patient was placed in the lateral decubitus position.Proper placement of the bronchial blocker was confirmed again through auscultation and fiberoptic visualization.Anesthesia was maintained with either sevoflurane or isoflurane as well as oxygen and air.Remifentanil was continuously infused for intraoperative analgesia.Intravenous dexmedetomidine was routinely administered.Using an anesthesia machine, pressure-controlled mechanical ventilation was given.The bronchial blocker was inflated under fiberoptic control to achieve one-lung ventilation.The patient received 100% inspiratory oxygen concentration and over time, "the inspired oxygen concentration was gradually decreased, titrating to maintain a spo2 >95%".Ventilator settings were adjusted during the procedure with smaller tidal volumes and increased respiratory rates.Peak inspiratory pressure was limited to <30 cmh2o, which allowed a degree of permissive hypercapnia.It was noted that with use of the arndt endobronchial blocker, the lung could be "emptied via the working canal when the lasso was removed".The patient was presumably administered a bolus of intravenous morphine and paracetamol intraoperatively "and skin wound infiltration with 0.25% levobupivacaine" near the end of the procedure.Open thoracotomy was not performed.Thoracic ct imaging showed the prenatally detected lung lesion(s).During the procedure for patient 21, the arndt endobronchial blocker balloon was noted to have leaked, leading to re-expansion of the left lung during surgical resection, which is the subject of this report.As a result, the device was exchanged for a competitor catheter under bronchoscope guidance.After roughly 30 minutes on one-lung ventilation, the replacement catheter was noted to have "slipped out".To re-establish one-lung ventilation, the endotracheal tube was "pushed into the right main bronchus under fiberoptic bronchoscope visualization".The patient did not experience any adverse effects as a result.Mohtar, sanah, et al.¿anesthetic management of thoracoscopic resection of lung lesions in small children.¿ wiley online library, john wiley & sons, ltd, 3 oct.2018, onlinelibrary.Wiley.Com/doi/10.1111/pan.13502.

Manufacturer Narrative

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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.On 26jul2021, cook was notified by (b)(6) hospital in hong kong of a journal article, "anesthetic management of thoracoscopic resection of lung lesions in small children".In the article an issue was reported with a balloon from arndt endobronchial blocker set (c-aebs-5.0-50-sph-as) from an unknown lot.The balloon leaked leading to the re-expansion of the left lung during the surgery, and the blocker was removed.Then the doctor tried to use a fogerty catheter, but it slipped out after 30 minutes.The endotracheal tube was pushed into the right main bronchus to re-establish one-lung ventilation.No additional adverse events related to the incident were reported.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device were 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.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales data for three years after the journal article was submitted.The three lots (6741423, 7336905, and 7415163) were sold to the customer in that time.The device history record for all three found no relevant non-conformances.A database search for complaints on the three lots found one additional complaint for the lot 6741423; but that complaint, balloon not opening properly, does not relate the current complaint of balloon leakage.Based on the dmr, device history record, and design history file review, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed current product labeling.The current product ifu, [c_t_aebs_rev6] ¿arndt endobronchial blocker set,¿ provides the following information to the user related to the reported failure mode: warnings: the enclosed blocker balloon is a high-volume, low-pressure design, excessive manipulation over a prolonged period may cause balloon rupture or deflation.How supplied: ¿-upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no returned device, and the results of the investigation, it was determined the cause of this event is related to component failure.It is possible that patient anatomy attributed to the failure, though this cannot be confirmed without additional information.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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Type of Device: CBI TUBE, TRACHEAL/BRONCHIAL
• 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: 12314161
• MDR Text Key: 266897287
• Report Number: 1820334-2021-01972
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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-AEBS-5.0-50-SPH-AS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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
• Treatment: 4.5 MM MICROCUFF TRACHEAL TUBE (KIMBERLY-CLARK); FLEXIBLE FIBEROPTIC BRONCHOSCOPE; FOGARTY CATHETER; GENERAL ELECTRIC AESTIVA (DATEXOHMEDA, INC); INTELLIVUE MP90 (PHILIPS HEALTHCARE); UNCUFFED ENDOTRACHEAL TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 13 KG