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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2017
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
International customer reported that a patient was undergoing a video assisted thorascopic surgery (vats) procedure for an unspecified indication.An arndt endobronchial blocker set was employed to selectively isolate an unspecified pulmonary lobe for ventilation.The customer stated that the device had a major leakage while attempting to ventilate the patient.The device could not be "tightened;" the leakage could not be controlled or stopped.The instructions for use indicate that air leakage can be controlled by screwing down the cap on the blocker port.It is not known what actions were taken to address or complete the procedure, however a nurse reported that the device was not used once the leak was noted.No further information was provided.The device is not available for examination.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the device history record, documentation, drawing, instructions for use, manufacturing instructions, quality control, specifications, trends, and a visual inspection of the returned device were conducted during the investigation.The inspection of the returned device confirmed that, although the balloon was asymmetrical upon inflation, it did not leak during testing.The reported condition was therefore not confirmed.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 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, the examination of the returned product, 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.

• 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: 6432150
• Report Number: 1820334-2017-00619
• Device Sequence Number: 19068336
• Product Code: CBI
• UDI-Device Identifier: 00827002441095
• UDI-Public: (01)00827002441095(17)190309(10)6801122
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K002288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2017

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-5.0-50-SPH-AS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 17