MAUDE Adverse Event Report: COOK INC

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

Patient Problems Air Embolism (1697); Bradycardia (1751); Paralysis (1997); Loss of consciousness (2418); Low Oxygen Saturation (2477); Convulsion/Seizure (4406)

Event Type  Injury  

Manufacturer Narrative

Date of event: prior to (b)(6) 2020.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 a literature article that a patient experienced cerebral air embolism during a pleural lavage for management of an empyema with the use of an unknown cook 14-french wayne catheter.The (b)(6) female patient presented to the user facility for left pleural effusion.Analysis of the pleural fluid revealed "low glycopleuria, a majority of altered neutrophils, and positive cultures for veillonella atypica and prevotella melaninogenica".In response, the wayne catheter was inserted into the pleural cavity for daily saline irrigation (500 ml).Following, concomitant intravenous antibiotics were started.On day 7, immediately after pleural lavage with saline irrigation, the patient presented with focal neurologic seizures and other signs related to cerebral air embolism.Her condition "worsened with desaturation, bradycardia, and loss of consciousness (glasgow scale 7)".A neurologic examination revealed right hemiplegia along with central facial paralysis.The patient was then admitted to the user facility's intensive care unit (icu), where she had a generalized tonic-clonic seizure requiring mechanical ventilation.No fever was noted, and blood lactate level was reported normal at 1.7 mmol/l.A brain ct scan revealed multiple airisodense spots in the left corona radiata region, suggesting cerebral air embolisms.It was also reported that the "electroencephalogram was normal".Due to persistent neurological deficit, within four hours, the patient underwent hyperbaric oxygen therapy (hbot protocol- "a 10-minute session at 4 ata followed by 50 minutes of 100% oxygen at 1.9 ata") with a siphoning pleural catheter to prevent barotrauma.Another brain ct scan (48 hours) revealed regression of the air-isodense spots as well as an ischemic left precentral lesion.It was reported that the patient's condition had "rapidly improved" and that "she had favorable neurologic evolution within a few days, without parenchymal sequelae on brain mri 6 weeks later".Fibrinolytics were not used.Saline serum was delivered by gravity.No pressure was applied to increase infusion speed.To allow free drainage, the catheter was placed in the siphoning position following each saline delivery.During the episode of sudden desaturation, the patient "was free of venous catheter".Capron, t., guinde, j., laroumagne, s., dutau, h., & astoul, p.(2020, october 1).Cerebral air embolism after pleural lavage for empyema.The annals of thoracic surgery.Https://www.Annalsthoracicsurgery.Org/article/s0003-4975(20)30445-8/fulltext.

Event Description

In additional information received on 21jun2021, it was reported that the patient suffered from emphysema of the pleura requiring the installation of a drain to wash the pleura, as it was very damaged.The physician confirms that the drain is not believed to be the cause of the air embolism.As the author of the article has left the facility, no further information regarding this event is available.

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

Cook received a complaint via the journal article "cerebral air embolism after pleural lavage for empyema" by thibaut capron, phd et.Al.The event occurred at hopital nord in france, and the device is an unspecified 14fr wayne catheter.The device reportedly was in place when the patient experienced a cerebral air embolism after daily pleural lavage for empyema.The device was being used for daily saline irrigation and concomitant intravenous antibiotics.On day seven, immediately after the end of the pleural lavage, her condition worsened with desaturation, bradycardia, and loss of consciousness.Neurologic examination found right hemiplegia and central facial paralysis.She was admitted to the intensive care unit, where she experienced a generalized tonic-clonic seizure, and mechanical ventilation was required.She had no fever and blood lactates were normal.The embolism was confirmed via brain computed tomography (ct) scan.Owing to the persistent neurological deficit, the patient received hyperbaric oxygen therapy with a siphoning pleural catheter to prevent barotrauma.The brain ct scan at 48 hours found a regression of the air-isodense spots but the appearance of an ischemic left precentral lesion.Her condition rapidly improved, and she had favorable neurologic evolution within a few days.The patient had several pre-existing conditions including emphysema of the pleura.A review of the complaint history, instructions for use (ifu), and quality control procedures of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be conducted.However, a document based investigation evaluation was performed.A device master record (dmr) review, including device quality control document, concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the current product labeling.The product ifu, [c_t_waynemod_rev5] ¿wayne pneumothrax set,¿ provides the following information to the user related to the reported failure mode: contraindications: ¿not recommended for large accumulation or hemothorax.¿ precautions: ¿lung puncture may result in an air embolus, which could lead to ischemia or infarction of major organs, including the brain or cardiac system.¿ the lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The information provided upon review of the dmr and the ifu, suggest that there is no evidence the device was manufactured out of specification or that there are non-conforming devices in house or out in the field.The user facility stated that the cook device did not contribute to the reported adverse event.Based on the information provided and the results of the investigation, it was concluded that the adverse event was possibly related to the procedure and/or patient's condition due to the noted pre-existing conditions.The appropriate internal personnel have been notified.Per the 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.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12025808
• MDR Text Key: 266411830
• Report Number: 1820334-2021-01542
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 09/16/2021
• Supplement Dates FDA Received: 06/24/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 69 YR