MAUDE Adverse Event Report: COOK INC ARNDT ENDOBRONCHIAL BLOCKER SET; CBI TUBE, TRACHEAL/BRONCHIAL

Model Number N/A

Device Problems Break (1069); Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that the balloon of an arndt endobronchial blocker set leaked during an unknown procedure on an unknown patient.As the device was placed with the aid of a bronchoscope, it was discovered that the balloon had a leak and would not inflate as expected.The device was then removed from the patient, and the user confirmed the presence of an air leak in the balloon.The user noted that the device was not tested before insertion.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Initial reporter name and address: customer (person): phone: (b)(6).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 cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

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 cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information from the customer, it was reported that the patient did not have tortuous anatomy.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: a representative of (b)(6) (china) informed cook that on (b)(6) 2022, the balloon in an arndt endobronchial blocker set (rpn: c-aebs-7.0-65-sph-as; lot: 14374771) was leaking.After fixing the balloon to the bronchoscope, it was found that the balloon would not inflate like normal.The balloon was retracted, and it was confirmed there was a leaking issue.The balloon was not test inflated prior to insertion.It was reported that the patient did not experience any adverse effect due to this occurrence.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection and functional test for the returned device, were conducted during the investigation.Cook received one used c-aebs-7.0-65-sph-as device.A pin hole leak was noted in the balloon, but not at the seam or the bonds.This part is supplied to cook, and a supplier investigation was sent.The supplier investigation was not able to identify a root cause but found no issues with the reported lot.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 14374771 and raw material lot records no non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no non-conforming product from this lot exists 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.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.¿ the information provided upon review of the dmr, dhr, ifu and dfa (device failure analysis) does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or 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 the event.The customer stated that they did not test inflate before inserting the balloon into the patient.It is possible that the balloon became damaged after being inserted, but cook cannot confirm this without more 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.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Type of Device: CBI TUBE, TRACHEAL/BRONCHIAL
• 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: 16023514
• MDR Text Key: 308374350
• Report Number: 1820334-2022-01874
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• PMA/PMN Number: K021920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-AEBS-7.0-65-SPH-AS
• Device Lot Number: 14374771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS SOFT MIRROR