ARNDT ENDOBRONCHIAL BLOCKER SET

Description of Event or Problem

IT WAS REPORTED THAT THE BRONCHIAL BLOCKER BALLOON INCLUDED IN AN ARNDT ENDOBRONCHIAL SET LEAKED. AN UNKNOWN PATIENT WAS UNDERGOING AN ENDOBRONCHIAL BIOPSY IN WHICH THE BRONCHIAL OCCLUSION CATHETER NEEDED TO BE PRE-POSITIONED TO PREVENT MASSIVE HEMOPTYSIS. DURING PREOPERATIVE PREPARATION, AN INFLATION TEST WAS PERFORMED ON THE BALLOON, REVEALING THAT THE BALLOON FAILED TO INFLATE NORMALLY. THE BALLOON WAS THEN PRESSURIZED (INFLATED) AND RETESTED UNDER WATER; EXTENSIVE AIR BUBBLES WERE OBSERVED IN THE WATER, CONFIRMING AIR LEAKAGE OF THE PRODUCT. TO ENSURE A SMOOTH PROCEDURE, THE CLINICIAN IMMEDIATELY REPLACED IT WITH A NEW DEVICE, AND THE SUBSEQUENT OPERATION WAS COMPLETED WITHOUT INCIDENT. A CUSTOMER PROVIDED VIDEO REVEALS THE REPORTED AIR LEAKAGE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 - PHONE NUMBER: (B)(6). H3 - DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. AWAITING DEVICE RETURN. 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.