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

Model Number	N/A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
During a esophagectomy on a (b)(6) female patient, while the balloon was inflating, the device failed to inflate evenly to isolate one lung which resulted in an impression and subsequent bleeding of part of airway in main stem bronchus, right side.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, functional and visual inspection of the returned device was conducted during the investigation.One arndt endobronchial blocker set was returned for evaluation.Visual exam noted no visible defects to the manifold.Both proximal and distal balloon bonds were secure.Functional testing was conducted by inflating and submerging the device.The balloon was found to be free of leaks and the customer report of asymmetrical balloon inflation was confirmed.There is no requirement in final inspection regarding the shape or degree of asymmetric inflation.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Customer reported that a patient underwent a planned esophagectomy for an esophageal repair.An arndt endobronchial blocker set was used to selectively block one lung during the procedure.The device was set within the main bronchus of the right lung and reportedly failed to inflate evenly.The event allegedly caused an impression / indentation of the lung tissue ( bronchus) with localized capillary bleeding.No intervention was needed to alleviate the impression or to control the capillary ooze.

• 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: 6092502
• Report Number: 1820334-2016-01268
• Device Sequence Number: 1694402
• Product Code: CBI
• UDI-Device Identifier: 00827002441149
• UDI-Public: (01)00827002441149(17)190112(10)6512913
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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-AS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 52