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

Model Number N/A

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: administration officer.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 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 Description

It was reported that the balloon of a arndt endobronchial blocker set would not inflate for use during a cryobronchoscopy procedure, so a new device was obtained.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

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

Additional information from the customer confirmed that the balloon was inflated with saline and was tested prior to use.

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 unknown, unavailable, or unchanged.Investigation ¿ evaluation.(b)(6) hospital (australia) informed cook that on (b)(6) 2022 the balloon in a arndt endobronchial blocker set (rpn: c-aebs-5.0-65-sph-as; lot number: unknown) would not inflate for use during a cryobronchoscopy procedure.The balloon was tested prior to use, and saline was used to test inflation.A new set was used to complete the procedure.It was reported that there were no adverse effects to the patient due to this event.Reviews of documentation including the quality control procedure, specifications, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used aebs device was returned to cook for evaluation.The balloon was inflated, and a pin hole leak was noted at the distal bond of the balloon.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint devices.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.The information provided upon review of device master 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.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: ¿following insertion of the blocker balloon through the multiport adapter, the balloon should be test inflated.¿ instructions for use: ¿9.Under bronchoscopic vision, inflate the balloon with air using the pilot balloon assembly.¿ 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 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 Description

Preliminary review the returned device noted a pinhole leak near the distal end of the balloon.

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 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 ; 8128294891
• MDR Report Key: 15472678
• MDR Text Key: 306256594
• Report Number: 1820334-2022-01517
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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-5.0-65-SPH-AS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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