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	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a - additional common device name- bts tube, bronchial (w/wo connector).D2b - additional product code: bts.H3 - device evaluated by mfg: device evaluation anticipated but 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 failed to inflate and leaked during an airway cryobiopsy procedure in a patient of unknown age and gender.The balloon was inflated with 5ml of air.The procedure was successfully completed using a new device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - medical device problem code (annex a).Additional information: e1 - address, city, and email.Investigation ¿ evaluation.It was reported that the balloon included in the arndt endobronchial blocker set failed to inflate and leaked during an airway cryobiopsy procedure in a patient of unknown age and gender.The balloon was inflated with 5ml of air.The procedure was successfully completed using a 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), drawing, quality control procedures, manufacturing instructions, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one used balloon catheter from the customer.Visual inspection confirmed that the balloon was damaged/ruptured.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 device lot found some relevant nonconformance that could have contributed to the reported failure mode in which all the nonconforming products were scrapped.It should be noted that there were no other complaints associated with the final product lot number.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.Following insertion of the blocker balloon through he multiport adapter, the balloon should be test inflated¿ 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.9.Do not overinflate balloon.Average inflation volumes 7.0 adult spherical 2.0cc-6.0cc¿ evidence gathered upon review of dmr, ifu, dhr, and device failure analysis indicates the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Based on the information provided, inspection of the returned product, and the results of the investigation, it was concluded that a component failure unrelated to manufacturing deficiencies contributed to the reported event.It is possible that the balloon was damaged after insertion, but cook cannot confirm this.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.

• 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: 21701082
• Report Number: 1820334-2025-00295
• Device Sequence Number: 7844477
• Product Code: CBI
• UDI-Device Identifier: 00827002441149
• UDI-Public: (01)00827002441149(17)270905(10)16238077
• 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): 08/14/2025

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: 16238077
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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