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

Model Number	G13279
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: assistant chief inahlo.Pma/510(k) #: k160542.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the balloon in an arndt endobronchial blocker set did not inflate evenly.The balloon only inflated on one side.Another balloon was needed to complete the procedure.The procedure being performed was an isolation of the lung for thoracic surgery.No other adverse effects have been reported for this incident.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a functional test, dimensional verification, and visual inspection of the returned device was conducted during the investigation.One aebs catheter was returned to cook for investigation.Upon visual inspection, only one side of the balloon was inflated.A functional test was performed to test the balloon's ability to inflate and remain inflated.The balloon¿s diameter was measured within specification, therefore there is no indication the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the complaint lot (9716354) found no non-conformances that could be potentially related to this event.A database search revealed no other events associated with the provided complaint lot.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no related non-conformances, and no additional complaints from the same lot, cook has concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿arndt endobronchial blocker set¿ [c_t_aebs_rev6], provides the following information to the user related to the reported failure mode: instructions for use: -¿for a french size 5.0 catheter, the recommended average inflation volume is.5 cc - 2.0 cc.¿ how supplied: -¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned product, and the results of our investigation, a concluding cause can likely be traced to device component failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.

• 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: 9273405
• Report Number: 1820334-2019-02766
• Device Sequence Number: 114440
• Product Code: CBI
• UDI-Device Identifier: 00827002132795
• UDI-Public: (01)00827002132795(17)220506(10)9716354
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 05/06/2022
• Device Model Number: G13279
• Device Catalogue Number: C-AEBS-5.0-50-SPH
• Device Lot Number: 9716354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1