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

Catalog Number C-AEBS-9.0-78-SPH-AS

Device Problem Difficult to Advance (2920)

Patient Problem Bleeding (1738)

Event Date 01/15/2015

Event Type  Injury  

Event Description

The initial info provided (b)(6) 2015 stated that: the arndt endobronchial blocker set could not be placed.New info provided 01/26/2015: during a bronchoscopy procedure on a (b)(6) male pt with preexisting condition of chronic heart and lung disease, with lung bleeding, the arndt endobronchial blocker set could not be placed via bronchoscope through the endotracheal tube 2.Per info provided by the initial reporter: the pt experienced adverse effects due to this occurrence: lung bleeding could not be stopped at first and the customer had to use alternatives (longer procedure), and the pt was transferred to a bigger hospital.Additional info in pt outcome note provided 02/06/2015: stated that the arndt endobronchial blocker set could not be placed via bronchoscope through the endotracheal tube 8.5 mm i.D.It was further stated the blocker was not being used to collapse the lung for a procedure, but was being used to stop the bleeding.

Manufacturer Narrative

(b)(4).Per info supplied by the customer, no product will be returned; therefore, reviews of the complain history, instructions for use and quality control were performed for the purpose of this investigation.Quality control final inspection of cohen endobronchial blocker set] states: "verify catheter tubing is smooth and clean." this product is shipped with instruction for use which states: step 6 "advance the bronchoscope into and through the guide loop, coupling the endobronchial blocker to the bronchoscope.This may be done with the multiport adapter, the endotracheal tube or the trachea proper.Note: the endobronchial blocker and bronchoscope may also be coupled together prior to attachment of the arndt multiport airway adapter to the endotracheal tube." step 7: "advance bronchoscope into the section of the lung to be blocked.Note: "the blocker guide loop may be cinched onto the bronchoscope by unscrewing the guide loop port and pulling back the snare.The snare may be affixed in placed by inserting syringe or cpap adapter into the guide loop port." / step 8: "keeping the bronchoscope position stable (loosen guide loop if snare is cinched onto bronchoscope), advance the endobronchial blocker until the guide loop is seen to exit the end of the bronchoscope." per the pt event info: "the rep believes the user has pulled the loop too tight to the bronchoscope; which prevented the blocker from being placed.Per the rep, the blocker was not being used to collapse the lung for a procedure, but was being used to stop the bleeding." we are unable to determine with certainty why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk severity, there is insufficient risk due to low occurrence and high detection.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Type of Device: CBI TUBE, TRACHEAL/BRONCHIAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4561874
• MDR Text Key: 5457743
• Report Number: 1820334-2015-00074
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2017
• Device Catalogue Number: C-AEBS-9.0-78-SPH-AS
• Device Lot Number: 5281551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR