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 Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
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 on a arndt endobronchial blocker set would not inflate and hold shape during a lung procedure.The bronchial blocker was placed in a single lumen tube from the package.The clinical team placed the balloon inside the lung in a one lung ventilation case.After placement the team attempted to fill the balloon, however, it would not inflate and hold shape.The device was removed from the patient and the balloon was visually inspected.The balloon appeared to be punctured or torn.A different blocker was used successfully in the patient.The arndt endobronchial blocker was not tested prior to being placed in the patient.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One catheter, syringe and adapter were returned for evaluation.Physical examination of the returned device showed a tear on the distal bonded area of the balloon to the catheter.The tear expands 2mm.No additional surface damage was noted on the surface of the device.The balloon was filled with air and did not hold shape.The balloon was then submerged in a beaker filled with water, and a syringe was used to fill the balloon with air.Only one tear was verified to be in the balloon.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.Design verifications are in place to meet design requirements related to this failure mode.A review of the device history record for lot 9597903 found no relevant nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for this lot number.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 not be established.Appropriate measures have been taken to address this failure mode.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and 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.

• 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: 8855770
• Report Number: 1820334-2019-01926
• Device Sequence Number: 2548952
• Product Code: CBI
• UDI-Device Identifier: 00827002132825
• UDI-Public: (01)00827002132825(17)220318(10)9597903
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 03/18/2022
• Device Model Number: N/A
• Device Catalogue Number: C-AEBS-9.0-78-SPH
• Device Lot Number: 9597903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 82