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

Model Number N/A

Device Problem Inflation Problem (1310)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2a.Common device name: tube, bronchial (w/wo connector) d2b.Procode: bts e1 - customer person: street: (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 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 Description

It was reported that the arndt endobronchial blocker set balloon did not inflate during a cryobiopsy of the left lung.The physician placed the cook arndt endobronchial blocker through the multiport adapter and tested for inflation using 15 cc/ml inflation volume.When attempting to place the arndt endobronchial blocker the balloon would not inflate.Another arndt endobronchial blocker set was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

In additional information received on (b)(6) 2023, it was confirmed that the volume used to inflate the balloon was 5cc.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 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

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: h6 - annex a investigation ¿ evaluation it was reported that the arndt endobronchial blocker set balloon did not inflate during a cryobiopsy of the left lung.The physician placed the cook arndt endobronchial blocker through the multiport adapter and tested for inflation using 5 ml inflation volume.When attempting to place the arndt endobronchial blocker the balloon would not inflate.Another arndt endobronchial blocker set was used to complete the procedure.There were no adverse effects to the patient 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 function test of the returned device, were conducted during the investigation.Cook received on used aebs balloon catheter.Attempting to inflate the balloon found a pin hole leak next to the bonded area of the balloon.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 dhr for the reported lot and records one relevant non-conformance for balloon damage.There is multiple 100% inspections in place to identify this failure before shipping; all non-conforming material was scrapped.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no non-conforming product for 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.Caution is recommended when working near the hilum.The balloon position should be verified to prevent inadvertent balloon damage.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, device evaluation, and ifu 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 this incident.It is possible that the patient¿s anatomy damaged the balloon, but cook cannot confirm this.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: 18320432
• MDR Text Key: 330467102
• Report Number: 1820334-2023-01696
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 10827002441146
• UDI-Public: (01)10827002441146(17)250930(10)14984933
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K021920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 14984933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 71 KG