MAUDE Adverse Event Report: UNKNOWN; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

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

Patient Problems Laceration(s) (1946); Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

The event is currently under investigation.

Event Description

Noboru oda, md, et al: tension pneumoperitoneum as the sole presentation of an intraoperative bronchial rupture.The journal of heart and lung transplantation, vol 29, no 9, september 2010.The above referenced journal article alleged that a (b)(6) woman underwent a bilateral lung transplant secondary to primary pulmonary hypertension.Intraoperatively, lung isolation was achieved with a 39f left disposable polyvinylchloride double-lumen tube ((b)(4); mallinckrodt medical, (b)(4)).Both balloons were slowly inflated to prevent underwater gas escape during 1-lung ventilation (5 cm3 in the tracheal and 2 cm3 in the bronchial cuffs).Appropriate inflation was confirmed by palpation.Sequential bilateral lung transplantations were carried out through a clamshell incision.Throughout the procedure, both cuffs remained inflated, were frequently checked, and required no additional manipulation.After completion of the surgery, the dlt was atraumatically changed to a single-lumen 8.0 endotracheal tube using a soft-tipped cook airway exchange catheter through the tracheal lumen, followed by an unremarkable bronchoscopic examination of the airways and suture lines.No air leaks through the bilateral chest tubes or loss of volume during mechanical ventilation were noted.The patient was transferred to the intensive care unit in stable condition, where pressure-controlled ventilation was continued.Within 1 hour, progressive abdominal distention developed, partial pressure of arterial oxygen decreased to 69 mm hg (fraction of inspired oxygen, 0.6), and mild hypotension developed.X-ray imaging demonstrated gas under both domes of the diaphragm, without pneumothorax or pneumomediastinum.Reopening of the thoracotomy at the bedside did not reveal an air leak or tension pneumothorax.An urgent bedside laparotomy released intraperitoneal gas with an anesthetic (but not fecal) smell and revealed no intestinal perforation.Filling the peritoneum with saline solution demonstrated air bubbles at the esophageal hiatus coincident with the inspiratory phase of the ventilator.Repeat bedside bronchoscopy failed to identify a tracheobronchial tear.The patient was returned to the operating room for an explorative thoracotomy.Repeat bronchoscopy with a larger bronchoscope revealed a linear 1.5-cm longitudinal tear in the membranous portion of the recipients left mainstem bronchus.The tear was located 1 cm proximal to the left bronchial anastomosis and was covered with the parietal pleura.Surgical repair of this laceration was successful.The patient recovered completely and was discharged home 37 days later.

Manufacturer Narrative

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.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure , specifically: " warnings attention should be paid to the insertion depth of catheter into patient's airway and correct tracheal position of replacement endotracheal tube.Catheter and endotracheal tube should not be advanced beyond the carina.To avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferable 2-3 cm." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined; however, since the tear occurred in the patient's left mainstem bronchus which is further down beyond the carina, the catheter could have been advanced too far and against ifu warnings, resulting in barotrauma.Based on the information reported in the journal article, suggests the reported event may be associated with physician technique and procedure.

• Brand Name: UNKNOWN
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6095723
• MDR Text Key: 59720358
• Report Number: 1820334-2016-01293
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 69