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| Model Number N/A |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012); Mediastinal Shift (2198)
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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It was reported in a literature article that a (b)(6) year-old female patient developed a sudden tension pneumothorax that lead to cardiovascular collapse after using an aintree intubation catheter during a tracheostomy and open gastrostomy tube placement procedure.The patient was recommended for tracheostomy and open gastrostomy tube placement 17 days after experiencing a "hemorrhagic cerebrovascular accident secondary to a ruptured cerebral aneurysm" in preparation for transfer to a nursing facility.The patient had a large thyroid mass that completely covered the anterior and lateral surfaces of their trachea, including the proposed surgical location for tracheostomy insertion.As a result, plans were made to resect the thyroid isthmus with central thyroidectomy.As airway protection in a patient not likely to tolerate long periods of apnea was a concern, anesthetic plans for the procedure included passing an aintree intubation catheter for airway protection while the oral endotracheal tube (ett) was exchanged for a tracheostomy airway device.The primary advantage of this approach was to "maintain the patient¿s airway in the event of an obstructed surgical field and interval ventilation through the device itself should the procedure prove long and technically difficult".The patient was transported to the operating room and administered an inhaled anesthesia and intravenous paralytic gently at low concentrations which were maintained in the same fashion along with small doses of narcotics as deemed necessary.The gastrostomy was performed first without reported complications.Following, the patient's surgical team proceeded with the thyroid isthmusectomy portion of the procedure without any obvious complications apart from continuous oozing blood from the margins of the remaining thyroid tissue.At this point in the procedure, "the aec was then carefully passed down the ett noting the depth along the markings of the aec in correlation with the ett and attached to a jet ventilator".Manual jet ventilation was then performed; however, the patient immediately experienced significant hypotension that was monitored by arterial line blood pressure tracing following no more than two breaths delivered by jet ventilation.The ett was replaced to its original position and the aec was removed immediately.Ventilation was resumed through the ett.Saturation of peripheral oxygen by standard pulse oxymetry remained at 98-100% and the patient's heart rate did not increase above 20% from baseline.Additionally, "peak and plateau airway pressures and tidal volumes were noted to be nearly identical on resumption of ventilation through the ett and end tidal co2 values decreased less than 10% of previous values".Five-lead electrocardiogram leads were in place and an intraoperative ecg did not show any changes from baseline that were significant.The patient was immediately administered several intravenous vasoactive medications and escalating doses of epinephrine and an epinephrine infusion for blood pressure.No further attempts were made for jet ventilation.As the trachea was fully exposed, a trachea incision was made and the tracheostomy was inserted without reported complications.Upon arriving to the icu, the patient's hypotension continued.A chest x-ray was performed immediately as there were suspicions of decreased breath sounds on the left which confirmed a large left-sided tension pneumothorax with mediastinal shift which presented in an "atypical manner".There was also evidence of left heart compression.A chest tube was then introduced to relieve a large volume of air and to allow the weaning of the epinephrine infusion (which was stopped completely two days following the procedure).The patient was "eventually deemed medically stable for transfer to a skilled nursing facility, after prolonged hospitalization, with a functional tracheostomy airway and nutrition with gastrostomy tube feeds".Additional information regarding the patient, device, and event has been requested but is currently unavailable.Rashid1, ali m.¿pneumothorax, an underappreciated complication with an airway exchange catheter.¿ journal of thoracic disease, dec.2012, jtd.Amegroups.Com/article/view/632/html.
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Event Description
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No additional patient/event information has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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H6 ¿ method code: (4114) device not returned.Investigation - evaluation: it was reported in a journal article (pneumothorax, an underappreciated complication with an airway exchange catheter, rashid et al, 2012) that a patient experienced tension pneumothorax leading to cardiovascular collapse.An aintree intubation catheter (c-cae-19.0-56-aic) was used with jet ventilation.Cook became aware of this event on 21apr2020 upon reading the journal article.The patient eventually became stable after prolonged hospitalization.A review of the instructions for use (ifu), quality control and trends 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.A review of the device master record (dmr) concluded that sufficient controls are in place to detect potentially related failure modes prior to release.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) could not be completed due to a lack of lot information from the user facility.Based on this information, cook has concluded that the device was manufactured to specification and that there is no evidence of non-conforming product existing either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document for the aintree intubation catheter is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿warnings use of the rapi-fit adapter for oxygenation may be associated with a risk of barotrauma.Use of an oxygen source should only be considered if the patient has sufficient egression of the insufflated gas volume.If a high-pressure oxygen source is used for insufflation (e.G., jet ventilator), begin at a lower pressure and work up gradually.Rising chest wall, pulse oximetry and oral air flow should be carefully monitored.¿ based on the information provided, no product returned, and the results of the investigation, a root cause was potentially traced to unintended user error.The ifu describes that use of the rapi-fit adapter for oxygenation may be associated with a risk of barotrauma.It warns to start at a low pressure then work up gradually if using a high-pressure oxygen source, such as the jet ventilation described in the journal article.No information was provided regarding the device position, or ventilation technique, so it cannot be confirmed whether or not the attending physician failed to follow these instructions.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.
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