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

Catalog Number C-AEBS-5.0-65-SPH-AS

Device Problem Inflation Problem (1310)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510(k) #: k160542.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

It was reported that the balloon of an arndt endobronchial blocker set did not inflate evenly during use.Additional information regarding patient outcome and event details has been requested but is currently unavailable.It is unknown if the patient experienced any adverse effects due to this occurrence.

Manufacturer Narrative

Correction: h6- annex e and f.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 received on 23nov2022, it was confirmed that the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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

Additional information received on 21nov2022.When the balloon was inflated before use, it inflated on only one side.Another device was used to complete the procedure.

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: osaka women¿s and children¿s hospital (japan) informed cook that on 13oct2022 the balloon in an arndt endobronchial blocker set (rpn: c-aebs-5.0-65-sph-as; lot #: 14594765) inflated unevenly.When the balloon was inflated before use, only one side inflated.Another device was used instead.There were no adverse effects experienced by the patient due to this occurrence.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, 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 c-aebs-5.0-65-sph-as.When the balloon was inflated it did not inflate fully/inflated unevenly.The o.D.Of the balloon measured within specification.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 for lot 14594765 and records no relevant non-conformances.A database search for complaints on the reported lot found one additional complaint reported from the field.The complaint is from the same facility and was for the same reported failure of uneven inflation.The investigated for that complaint concluded that there was no problem detected with the device.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: precautions ¿inflate balloon initially under direct vision to ensure correct position and placement.¿ instructions for use ¿1.Fully deflate the balloon on the endobronchial blocker.¿ the information provided upon review of device master record, product labeling, device history record, and 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 available information, inspection of the returned device, and the results of the investigation, cook determined the root cause for this event is customer dissatisfaction.There is no issue with the device and the product meets manufacturing specifications.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 Description

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

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.An mdr guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.A detailed review of complaint history using a validated report revealed that there have been no deaths or serious injuries, per 21 cfr part 803.3, due to irregular/asymmetric inflation of the balloon of an arndt or cohen endobronchial blocker, from (b)(6) 2020 through (b)(6) 2023.Therefore, cook will cease malfunction reporting for events where there is irregular/asymmetric inflation of the balloon of an arndt or cohen endobronchial blocker.The recurrence of a serious injury or death for the same malfunction will trigger the resumption of mandatory reporting, per 21 cfr part 803.50.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.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.

• 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: 15650647
• MDR Text Key: 306902915
• Report Number: 1820334-2022-01649
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 00827002441118
• UDI-Public: (01)00827002441118(17)250314(10)14594765
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-AEBS-5.0-65-SPH-AS
• Device Lot Number: 14594765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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