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

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

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2b additional common device name: tube, bronchial bts.D2a (additional procode): bts.E1: phone : (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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 Description

Cook was notified that a arndt endobronchial blocker catheter would not inflate and was punctured.The product was immediately discarded and replaced.Another new product was used in the procedure and inflated normally.The procedure was completed without any issue.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information was provided on 09apr2024.The inflation volume used to inflate the balloon was 05 cc.The balloon was not test inflated prior to use.The patient did not have tortuous or calcified anatomy.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 19012010
• MDR Text Key: 339117702
• Report Number: 1820334-2024-00452
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 10827002441146
• UDI-Public: (01)10827002441146(17)260405(10)15371497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-AEBS-7.0-65-SPH-AS
• Device Lot Number: 15371497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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 Sex: Female