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 Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon of an arndt endobronchial blocker set ruptured during an attempt to stop bleeding in the trachea of an unknown patient.During an emergency situation, the blocker balloon was cuffed to stop tracheal bleeding.After a few short minutes, the physicians realized that the balloon had lost pressure.A second attempt was made to cuff the balloon; however, the attempt was unsuccessful.It appeared that the balloon had been damaged.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding event details has been requested but is currently unavailable.
Additional Manufacturer Narrative
D2a - common device name: additional names: bts; tube, bronchial (w/wo connector) d2b - product code: additional product codes: bts.H3 - device evaluated by mfg? device evaluation anticipated but has not 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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was provided on 25feb2026.The patient did not have tortuous anatomy.It is unknown if the device was test inflated before insertion because it was an emergency and no one is able to remember.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.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 unchanged, unknown, or unavailable.Additional information: d9 - date returned to mfg.Investigation ¿ evaluation it was reported that the balloon of an arndt endobronchial blocker set ruptured during an attempt to stop bleeding in the trachea of an unknown patient.During an emergency situation, the blocker balloon was cuffed to stop tracheal bleeding.After a few short minutes, the physicians realized that the balloon had lost pressure.A second attempt was made to cuff the balloon; however, the attempt was unsuccessful.It appeared that the balloon had been damaged.The patient did not have tortuous anatomy.It is unknown if the device was test inflated before insertion.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), drawings, manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one catheter and two adapters.Visual inspection of the catheter confirmed that the balloon had burst.There was no indication that the device was manufactured out of specification.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 revealed three devices were scrapped for a potentially related issue.The remainder of the lot was inspected with relevant 100% inspection activities.A complaint history search identified no other events reported for the related failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either 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: warnnings ¿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.¿ 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 unknown if the device was test inflated prior to use.Additionally, the device was used during an emergency situation, which may have caused damage to the balloon; 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: 24367763
• Report Number: 1820334-2026-00176
• Device Sequence Number: 18561693
• Product Code: CBI
• UDI-Device Identifier: 00827002441149
• UDI-Public: (01)00827002441149(17)280320(10)16518295
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 16518295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 04/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 02/26/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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