MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem Laceration(s) of Esophagus (2398)

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: product information currently unavailable.Common device name: unknown.Pma/510(k): unknown.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 a provider was performing a bedside tracheostomy with a percutaneous tracheostomy device when the patient developed a serious bleed in their lung.The user believes it was from the wire included in the tracheostomy kits.The report stated the patient was receiving extracorporeal membrane oxygenation (ecmo) during the procedure and the bleed was resolved with a bronchial blocker successfully.No other adverse events have been reported to date.As reported, "the patient is okay.".

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control were conducted during the investigation.Cook did not receive a device for investigation from the complainant.Cook has not received any related complaints with the same failure mode where the device was returned for investigation, so no past device investigation could be reference.At this time, there is no evidence suggesting that the device was manufactured out of specification.However, a document based investigation evaluation was performed.Cook completed a review of the product device master record and has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also completed a review of the device history record and found no nonconformances relevant to the failure mode on either the supplied final set lots, the wire component lots, or any additional final set lots that include the wire component lots.No devices from the supplied final set lots were able to be pulled from the distribution center for further testing, and a software search for complaints on all final lots consisting of the wire component lots found no additional complaints from the field.From this information, there is no evidence suggesting that there is nonconforming product in house or in the field.Based on the information provided, no inspection of returned product and the results of the investigation, a definitive cause could be established.Cook concluded that component failure, without design or manufacturing issue, contributed to the incident.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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

It was reported in additional information received on 24apr2019 that there was concern from the physician that the wire had caused the patient to bleed.The physician though that that dilator did not go well over the wire.The procedure was completed.The patient passed away a couple of days ago due to massive injuries from a trauma.No additional procedure was required and no further events have been reported to the endoscopy manager.In additional information received on 20may2019 reported that, the patient arrived on (b)(6)2019 as a result of a motorcycle vs.Vehicle accident.The patient was put on ecmo and a tracheostomy was performed.Heparin was administered.Bleeding in the lung was discovered on (b)(6) 2019 by pulmonology.A 9fr arndt blocker was used and collapsed the lung.This stopped the bleed in the lung and the patient became stable.On (b)(6) 2019, the patient died as a result of the injuries sustained from the accident with the vehicle.It was reported that the wire felt more stiff as usual and dilation was difficult during the tracheostomy procedure.The flexible end of the wire was inserted into the patient.No autopsy report, x-rays or death certificate will be available.A bronchoscope was used during the procedure.The lot number of the device used during the procedure could not be confirmed.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8551397
• MDR Text Key: 143213170
• Report Number: 1820334-2019-00995
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9FR ARNDT BLOCKER
• Patient Outcome(s): Required Intervention