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 Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3 - device evaluated by mfg.? device has been returned, and preliminary evaluation has been performed.However, our investigation is ongoing, and device evaluation summary will be included in our follow up report once our investigation has been completed.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
Cook was notified that during preoperative preparation; the balloon was test inflated and was found to inflate symmetrically and leak.The procedure was completed by using another device.The device was returned on (b)(6) 2025 and a pinhole was found in the seam of the balloon.The balloon was inflated with 2 cc of air, but would not stay inflated.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Correction: h6 - annex a.Investigation ¿ evaluation.Cook was notified that during preoperative preparation; the balloon was test inflated and was found to inflate symmetrically and leak.The procedure was completed by using another device.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 procedures, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection and functional test, of the returned device, were conducted during the investigation.One prior to use device was returned to cook for evaluation.A functional test of the device confirmed leakage.Upon visual inspection, a pin hole near the seam was noted.Cook has concluded that the device was manufactured to 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 and the related subassembly lots did not reveal any quality control discrepancies.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 products exist either in house or in field.Cook also reviewed product labeling.The ifu 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 available information, 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 damage occurred during device handling before the procedure however this cannot be confirmed.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 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
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: 23576088
• Report Number: 1820334-2025-01419
• Device Sequence Number: 9532495
• Product Code: CBI
• UDI-Device Identifier: 00827002441095
• UDI-Public: (01)00827002441095(17)271205(10)16367106
• 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): 03/17/2026

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: G44109
• Device Catalogue Number: C-AEBS-5.0-50-SPH-AS
• Device Lot Number: 16367106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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