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

Model Number	N/A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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 (b)(6) patient underwent a thoracoscopy for a chest wall tumor biopsy.An arndt endobronchial blocker set was employed to for anesthesia management during the procedure.The device was tested for leaks prior to use then inserted into one lung and inflated.The conditions, manipulations and circumstances surrounding the initial testing of the device are not known.The balloon deflated at an unspecified time during the procedure.The device was removed and a new device used.The event resulted in an extension of the procedure and anesthesia time.There were no reported adverse patient consequences.No further patient or device events were reported.Post removal examination of the device by the user revealed a leak at the junction of the pilot balloon assembly tube and the blue wing shaped component.The user commented that it was difficult to assess the leakage because the amount of leakage was dependent upon the orientation of the device; one orientation allowed for a slow leak which maintained balloon inflation and another orientation allowed for a rapid leak and subsequent deflation of the balloon.The instructions for use (ifu) state in the warnings section that " the enclosed blocker balloon is a high volume, low pressure design.Excessive manipulation over a prolonged period may cause balloon rupture or deflation.".
Additional Manufacturer Narrative
Method: labeling evaluation.Investigation ¿ evaluation: a review of the device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection and functional test of the returned device were conducted during the investigation.The visual inspection of the returned device noted no apparent damage to the device.However, a leak test confirmed that there was a leak within the device.There were no pinholes in the balloon; the leak was found in the extension tubing, at the connection between it and the manifold assembly.Additionally, a document based investigation evaluation was 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 that there are no other complaints reported 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 health 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: 6396866
• Report Number: 1820334-2017-00517
• Device Sequence Number: 1001897
• Product Code: CBI
• UDI-Device Identifier: 00827002269071
• UDI-Public: (01)00827002269071(17)191006(10)7336898
• Combination Product (Y/N): N
• 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): 04/27/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-AEBS-7.0-65-SPH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/27/2017
• 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: Required Intervention