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Blank fields on this form indicate the information is unknown or unavailable.B3 - date of event: event occurred on a tuesday.E1 - customer (entity): (b)(6) hospital, postal code:(b)(6).G4 ¿ pma/510(k) #: exempt.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 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 or that a death or serious injury occurred; nor is it admission 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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It was reported that a cook airway exchange catheter separated.A patient required long-term ventilatory management and tracheostomy was performed.After placing the tracheostomy tube, it was determined that a longer, spiral tube was required to accommodate the thickness of the subcutaneous tissue.The cook airway exchange catheter (cae) was obtained to assist with the tube exchange.Difficulty was experienced during the insertion of the tube as it was soft, and a decrease in oxygenation was observed.The cae it was removed and suctioning and ventilation were performed.Then the skin incision was extended by 1 cm and the tracheostomy was palpated.A new tracheostomy tube with a hole for guide wire access was inserted and the procedure was completed.It was noted that after tracheostomy placement, x-ray imaging was performed "almost daily"; however, the attending physician and nurse determined no abnormality on the images by comparing them to the previous day.About two weeks later, the tracheostomy tube was exchanged, and x-ray was performed to confirm the placement.At this time, the anesthesiologist identified a suspected foreign body on the image.A computed tomography (ct) scan was subsequently ordered which confirmed the presence a tubular foreign body directly under the glottis.The foreign body was removed with a nasal fiberoptic scope and forceps under general anesthesia.The patient then returned to the hospital ward.It was noted that the cae is an infrequently used device as it is typically only used in emergencies.No other adverse effects were reported for this incident.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that a cook airway exchange catheter separated.A patient required long-term ventilatory management and tracheostomy was performed.After placing the tracheostomy tube, it was determined that a longer, spiral tube was required to accommodate the thickness of the subcutaneous tissue.The cook airway exchange catheter (cae) was obtained to assist with the tube exchange.Difficulty was experienced during the insertion of the tube as it was soft, and a decrease in oxygenation was observed.The cae was removed, and suctioning and ventilation were performed.Then the skin incision was extended by 1 cm and the tracheostomy was palpated.A new tracheostomy tube with a hole for guide wire access was inserted and the procedure was completed.It was noted that after tracheostomy placement, x-ray imaging was performed "almost daily"; however, the attending physician and nurse determined no abnormality on the images by comparing them to the previous day.About two weeks later, the tracheostomy tube was exchanged, and x-ray was performed to confirm the placement.At this time, the anesthesiologist identified a suspected foreign body on the image.A computed tomography (ct) scan was subsequently ordered which confirmed the presence a tubular foreign body directly under the glottis.The foreign body was removed with a nasal fiberoptic scope and forceps under general anesthesia.The patient then returned to the hospital ward.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu) of the complaint 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.Based on the dmr and dhr, there is no indication the complaint device was manufactured out of specification.Cook did not identify any additional nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_cae_rev6] ¿cook airway exchange catheters with rapi-fit adapters,¿ provides the following information to the user related to the reported failure mode: ¿how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, cook concluded the cause of event to be component failure unrelated to any manufacturing design or deficiencies.The customer stated that after exchanging a tracheal tube, a foreign matter shading was noticed when anesthesiologists were checking over an x-ray photograph to confirm the position.A ct was ordered, and a residual tubular foreign matter was confirmed directly under the glottis.It was removed by nasal fiber and forceps while the patient was under anesthesia.It¿s possible the device was re-sterilized prior to the procedure, however based on the provided information, this cannot be confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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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