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	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon from an arndt endobronchial blocker set leaked.The device was required for a cryopulmonary biopsy.The balloon was test inflated with 4 ml when the leak was discovered.The procedure was completed by using another, new device as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D2a: additional common name: bts, tube, bronchial (w/wo connector).D2b: additional product code: bts.H3: device evaluated by mfg? device evaluation is anticipated but has 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.
Additional Manufacturer Narrative
Additional information: d9, e1 - phone number and email correction: d4 - primary udi number.E1 - phone number: (b)(6).Investigation ¿ evaluation: it was reported that the balloon from an arndt endobronchial blocker set leaked.The device was required for a cryopulmonary biopsy.The balloon was test inflated with 4 ml when the leak was discovered.The procedure was completed by using another, new 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), and quality control procedures, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.Cook received one prior to use set.The balloon was found to be ruptured and leaking.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 lot found one possible related discrepancy, in which all discrepant product was scrapped and the remaining inspected prior to further production.A complaint history search did not identify any additional events reported for this lot.Cook did not review product labeling.The manufacturer does not apply an ifu for this product.Instructions for use are applied by the local distribution partner.The information provided upon review of the dmr, dhr, and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out 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 became damaged during the pre-test; however, cook cannot confirm this 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 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: 22322595
• Report Number: 1820334-2025-00765
• Device Sequence Number: 8811951
• Product Code: CBI
• UDI-Device Identifier: 00827002441149
• UDI-Public: (01)00827002441149(17)280110(10)16413252
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: G44114
• Device Catalogue Number: C-AEBS-7.0-65-SPH-AS
• Device Lot Number: 16413252
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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 Age: 45 YR
• Patient Sex: Female
• Patient Weight: 41 KG