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

Model Number	G44109
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A5: ethnicity: chinese.H3: device evaluated by mfg? device evaluation anticipated, not yet begun.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
It was reported that the balloon included in the arndt endobronchial blocker set leaked during a cryopulmonary biopsy procedure for a 52-year-old female patient.Before the procedure, the device was pre-positioned.Upon insertion of the balloon into the airway, a leakage was observed, preventing effective occlusion.The device was replaced with a new one to complete the procedure successfully.The balloon was inflated with a volume of 10 mm.Additionally, the blocker, bronchoscope, and endotracheal tube were generously lubricated before advancing the blocker.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported that the balloon included in the arndt endobronchial blocker set leaked during a cryopulmonary biopsy procedure for a 52-year-old female patient.Before the procedure, the device was pre-positioned.Upon insertion of the balloon into the airway, a leakage was observed, preventing effective occlusion.The device was replaced with a new one to complete the procedure successfully.The balloon was inflated with a volume of 10 mm.Additionally, the blocker, bronchoscope, and endotracheal tube were generously lubricated before advancing the blocker.As reported, 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), quality control, manufacturing instructions (mi), and instructions for use (ifu), as well as a functional test and dimensional verification of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.A functional test of the device was unable to replicate the leakage failure after submerging the balloon into the water.The balloon was inflated with 2cc of air for 3-4min, and the balloon remained larger then the 0.275¿ o.D.Minimum.Cook did not confirm 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 dhrs for the reported complaint device lot revealed related non-conformances in which all non-conforming devices were scrapped.A complaint history search did not identify any other events associated with the reported device lot.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 ifu, [c_t_aebs_rev6] ¿arndt endobronchial blocker set¿, supplied with the device states the following in consideration of 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.How supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ 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 the event.It is possible the device was damaged during test inflation; however, this cannot be confirmed without additional information.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 toa 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: 21470300
• Report Number: 1820334-2025-00188
• Device Sequence Number: 8840022
• Product Code: CBI
• UDI-Device Identifier: 00827002441095
• UDI-Public: (01)00827002441095(17)261208(10)15795119
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K160542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: G44109
• Device Catalogue Number: C-AEBS-5.0-50-SPH-AS
• Device Lot Number: 15795119
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Race: Asian