MAUDE Adverse Event Report: COOK INC ARNDT ENDOBRONCHIAL BLOCKER SET; CBI TUBE, TRACHEAL/BRONCHIAL

Model Number	N/A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k160542.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the balloon of a arndt endobronchial blocker set was not able to inflate properly.The user attempted to inflate the balloon prior to patient use, but found that only one side was able to inflate.No patient contact was made.Additional information regarding the device and event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.H6 - method code: analysis of data provided by user/third party (4112) investigation ¿ evaluation.It was reported to cook that a prior to use arndt endobronchial blocker set (rpn: c-aebs-5.0-65-sph from lot# 13314786) only inflated on one side of the balloon.This incident was reported by(b)(6) in japan on (b)(6) 2020.Further communication with the user facility clarified that the procedure was completed using another c-aebs-5.0-65-sph.No adverse effects were reported.A review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control, as well as a visual inspection, functional test, and dimensional verification of the returned device was conducted during the investigation.One unused arndt endobronchial blocker with photos was returned for evaluation.No visible damage was noted to the device.The balloon inflated without difficulty; however, only one side of the balloon expanded.A dimensional verification of the device confirmed that the device was manufactured within specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 13314786 found one related nonconformance for balloon damage, in which one device was scrapped.It should be noted that there were no other complaints associated with this lot lumber.As adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information related to the reported failure mode: precautions ¿inflate balloon initially under direct vision to ensure correct position and placement.¿ instructions for use ¿fully deflate the balloon on the endobronchial blocker.¿ based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that the main cause of failure was attributed to a component failure unrelated to manufacturing or design deficiencies.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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 patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: g4- date received by manufacturer: the initial date reported was 16nov2020.However, this date has been updated to 18nov2020.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 or Problem Description
In additional information received on 24nov2020, it was reported that a second same device was used to complete the procedure.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Common Device Name: CBI TUBE, TRACHEAL/BRONCHIAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10870027
• Report Number: 1820334-2020-02163
• Device Sequence Number: 2636080
• Product Code: CBI
• UDI-Device Identifier: 00827002132801
• UDI-Public: (01)00827002132801(17)230720(10)13314786
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: N/A
• Device Catalogue Number: C-AEBS-5.0-65-SPH
• Device Lot Number: 13314786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 02/15/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 11/25/2020; 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1