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	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: teleflex ez blocker.Phone: (b)(6).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 the catheter from an arndt endobronchial blocker set leaked during an inflation test prior to an unknown procedure.To complete the procedure, the operator performed one lung ventilation with another endobronchial blocker from another manufacturer.The product did not make contact with the patient.No further information was provided regarding patient demographics or pre-existing conditions.
Additional Manufacturer Narrative
Investigation - evaluation: a review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and trends, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.A balloon catheter was returned for evaluation.No surface damage was noted, and relevant measurements were found to be within specification.A leak test was performed, with the balloon being submerged while inflated.Air bubbles were noted, and some deflation was visible over the course of 30 seconds.There appears to be a pinhole leak in the balloon near or on the bonded area.Due to this pinhole, balloon measurements could not be completed accurately.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product¿s design history file shows evidence of verifications in place to meet design requirements related to this failure mode.A review of the device history file found no nonconformances in lot ns9181292 that could have contributed to the failure mode.It should be noted that one other complaint was reported in this lot that concerns a separate failure mode for a missing component, and this, is unrelated to this complaint.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: this product is intended for use by clinicians trained and experienced in the use of bronchoscopes and airway anatomy.Standard techniques for use of bronchoscopes and endobronchial blockers should be employed.Following insertion of the blocker balloon through the multiport adapter, the balloon should be test inflated.How supplied: upon removal form package, inspect the product to ensure no damage has occurred.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could be traced to a component failure unrelated to design or manufacturing issues.The pinhole leak was noted prior to patient contact, so tortuous patient anatomy could not have been the cause.It is possible that the pinhole was caused by manipulation during the reported inflation testing, but this cannot be confirmed without additional information.Appropriate measures have been taken to investigate this failure mode.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 new event description information to report at this time.

• 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: 8617112
• Report Number: 1820334-2019-01231
• Device Sequence Number: 2180745
• Product Code: CBI
• UDI-Device Identifier: 00827002441200
• UDI-Public: (01)00827002441200(17)210921(10)NS9181292
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: 09/21/2021
• Device Model Number: N/A
• Device Catalogue Number: C-AEBS-9.0-78-SPH-AS
• Device Lot Number: NS9181292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1