MAUDE Adverse Event Report: COOK INC

Catalog Number	UNKNOWN
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch form indicates product code: tube, tracheal (w/wo connector) (btr), brand: exchange catheter, device type: tube, tracheal (w/wo connector).Customer contact information was not included in the report.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.See mw5087359.
Event or Problem Description
It was reported in a medwatch form that was received by cook inc.On 24jun2019 that a patient had an iatrogenic foreign body placed in their airway, which was promptly removed with a bronchoscope and forceps.The patient's endotracheal tube exchange was unsuccessful over a 14fr catheter (no device information).To confirm proper placement of endotracheal tube post exchange, a routine bronchoscopic exam was completed.During this exam, it was found that a small piece of yellow-colored material was visualized in the patient's main stem bronchus.The initial airway exchange catheter (no device information) was carefully examined and it was found that a small piece appeared to be missing from the distal end of the device.It is alleged that this piece sheared off from contact with a somewhat sharp intra-luminal surface with the double lumen endotracheal tube (no device information).Wire forceps were obtained and the foreign body was promptly removed by the anesthesia and thoracic surgery teams.No trauma was evident after removal and no sequela was anticipated.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
B4: report date was inadvertently left out of previous follow up medwatch report.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation.A review of documentation including complaint history, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned, therefore no physical examination could be performed.However, a document-based investigation was performed.Based on the review of current documentation, cook has concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode.A review of the device history record could not be completed due to unknown lot information.There is no evidence to suggest there is any nonconforming product in house or in field.The complaint was able to be confirmed based on customer testimony.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use: "warnings: 'ensure proper sizing of the exchange catheter within a double lumen endotracheal tube.Failure to do so may cause small fragments to be shaved off during removal of the exchange catheter'." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided and the results of the investigation, a definitive cause could not be established and the cause could not be traced to the device.It is possible that issues during the procedure or patient anatomy contributed to the failure.If too large of a catheter was chosen, it could have become caught somewhere in the airway during manipulation, leading to separation.It is also possible that the patient anatomy was tortuous, or calcified, leading to separation with any manipulation of the device.The various components used with the exchange catheter during the procedure also could have led to a portion becoming separated off.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.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8776596
• Report Number: 1820334-2019-01658
• Device Sequence Number: 2131562
• Product Code: BTR
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 09/05/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/05/2019; 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention