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

Catalog Number C-AEBS-7.0-65-SPH-AS

Device Problems Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the balloon of an arndt endobronchial blocker set deflated.The device was placed in the user facility's intensive care unit (icu) in response to hemoptysis due to pulmonary hemorrhage in a covid-19 positive patient.The device was inflated in the evening in the "main tern bronchus", but found deflated in the morning.Consequently, a bronchi blood clot developed and another device had to be placed.No other adverse effects to the patient have been reported.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Annex a.Customer (person): postal code: (b)(6).Investigation - evaluation: chuv (switzerland) informed cook that on (b)(6) 2021, the balloon in an arndt endobronchial blocker set (rpn: c-aebs-7.0-65-sph-as, lot: 13474984) deflated overnight.The patient was covid-19 positive and had pulmonary hemorrhage.The arndt endobronchial blocker was reported to have been used to prevent hemoptysis.The balloon was inflated in the main stem bronchus on the evening of (b)(6) 2021; however, the balloon was found to be deflated in the morning on (b)(6) 2021.The device was removed.The customer reported that the patient suffered a blood clot in the bronchi.In an additional procedure, another arndt endobronchial blocker was placed in the patient.A review of documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (13474984) revealed no recorded non-conformances relevant to the failure mode.A database search revealed two other complaints from the field associated with the reported device lot.One complaint was for occlusion and was determined to be unrelated to this failure mode (reported under medwatch report #:1820334-2021-01458).The other was reported from the same customer as this event (reported under medwatch report #:1820334-2021-01523).The failure occurred for the same procedural use in these two events.The complaint investigation for the similar complaint concluded the cause of the event was the user's failure to follow instructions and that there is no evidence of manufacturing deficiency.Based on the available information, cook has concluded that this device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [c_t_aebs_rev6] ¿arndt endobronchial blocker set,¿ provides the following information to the user related to the reported failure mode: intended use: "the arndt endobronchial blocker set is intended to differentially intubate a patient¿s bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation." warnings: ¿the enclosed blocker balloon is a high-volume, low-pressure design.Excessive manipulation over a prolonged period may cause balloon rupture or deflation.¿ precautions: ¿ caution is recommended when working near the hilum.The balloon position should be verified to prevent inadvertent balloon damage.Care should be taken to ensure the balloon remains fully inflated during longer procedures.¿ 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, no product returned, and the results of our investigation, the cause for this event has been traced to the user's failure to follow instructions.The ifu supplied with the device instructs users to ensure the balloon remains fully inflated during longer procedures.In this event, the device was used to isolate one lung due to pulmonary hemorrhage.The device remained in place overnight and as such, was not being used as an adjunct device within a primary procedure that required one-lung isolation (which is its intended use).Cook will send a letter to the customer informing them of off label use.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Type of Device: CBI TUBE, TRACHEAL/BRONCHIAL
• MDR Report Key: 12017212
• MDR Text Key: 256740914
• Report Number: 1820334-2021-01527
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 10827002441146
• UDI-Public: (01)10827002441146(17)231007(10)13474984
• Combination Product (y/n): N
• PMA/PMN Number: K021920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Catalogue Number: C-AEBS-7.0-65-SPH-AS
• Device Lot Number: 13474984
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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): Life Threatening; Required Intervention