MAUDE Adverse Event Report: COOK INC ARNDT ENDOBRONCHIAL BLOCKER SET; CBI - TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Model Number	G44114
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon of an arndt endobronchial blocker set did not inflate during test inflation with a syringe.Other devices were used to complete the one-lung ventilation procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D2a - common device name: additional names: tube, bronchial (w/wo connector) d2b - procode: additional product codes: bts e1 - customer (person): phone: (b)(6).H3 - device evaluated by mfg?: device evaluation anticipated but has yet begun.Awaiting device return.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex a).Additional information: b5, d9.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 or Problem Description
The device was returned for investigation on 13nov2025.During preliminary device evaluation, it was determined the balloon of the arndt endobronchial blocker catheter was torn.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that the balloon of an arndt endobronchial blocker set did not inflate during test inflation with a syringe.Other devices were used to complete the one-lung ventilation procedure.There were no adverse effects to the patient due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, drawing, and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one balloon catheter from the customer.Visual inspection confirmed the balloon was torn; therefore, the device cannot inflate.Additionally, 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 dhr for the reported complaint device lot records two quality control discrepancies for failed leak test.There are 100% inspections in place to identify this failure before shipping and all discrepancies were scrapped.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no non-conforming product from this lot exists in house or in the 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: 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: ¿care should be taken to ensure the balloon remains fully inflated during longer procedures.¿ instructions for use: ¿warning: the lungs should be carefully auscultated following initial endobronchial blocker placement and balloon inflation to ensure proper functioning of the endobronchial blocker.¿ the information provided upon review of dmr, dhr, ifu, and device failure analysis, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible the balloon was over inflated causing the balloon to burst; however, cook cannot confirm this.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.
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, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• 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: 22566493
• Report Number: 1820334-2025-00880
• Device Sequence Number: 19838923
• Product Code: CBI
• UDI-Device Identifier: 00827002441149
• UDI-Public: (01)00827002441149(17)270909(10)NS16241102
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K021920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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 Model Number: G44114
• Device Catalogue Number: C-AEBS-7.0-65-SPH-AS
• Device Lot Number: NS16241102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/16/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/17/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown