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

Model Number	N/A
Medical Device Problem Codes	Air Leak (1008); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the balloon portion of an arndt endobronchial blocker set would not remain inflated when used in the patient.The patient presented with bleeding in the lower right lung, so the operator elected to place the blocker in the right main stem.The balloon was then inflated to between 5 and 6 cc's of air.The adaptor was then screwed down, and rendered immovable.However, upon the rescoping of the patient the following day, the balloon was observed to be completely deflated.The balloon was then re-inflated and screwed into place once more - this time with 7 cc's of air; but, 8 hours later, the balloon was again found to be deflated.The bleeding finally ceased following numerous bronchoscopies using cold saline flushes.The patient had emphysema, and was on blood thinners.The product is reportedly unavailable for return.
Additional Manufacturer Narrative
Pma/510(k) #: k0219120.A review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions and quality control was completed during this investigation.The complaint device was not returned as it was discarded at the facility; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record shows no nonconforming events.In addition, there were no other reported complaints for this lot number.The ifu shipped with the arndt endobronchial blocker set states that this device is intended to be used during procedures that require one-lung ventilation and that standard techniques for endobronchial blockers should be employed.The device is not expected to be left unmonitored outside of procedure.Customer testimony that it was left overnight without monitoring is against the device's intended use.A potential contributing factor to the reported failure maybe an unexpectedly long time in use without monitoring; however, based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Common Device Name: CBI TUBE, TRACHEAL/BRONCHIAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6972720
• Report Number: 1820334-2017-03642
• Device Sequence Number: 18956995
• Product Code: CBI
• UDI-Device Identifier: 00827002269071
• UDI-Public: (01)00827002269071(17)200821(10)8158890
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: N/A
• Device Catalogue Number: C-AEBS-7.0-65-SPH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1