GATEWAY OTW 2.0MM X 15MM - CE

Description of Event or Problem

THE BALLOON (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHEN THE SUBJECT BALLOON WAS PLACED AT TARGET LOCATION AND ATTEMPTED TO INFLATE THE BALLOON FAILED TO MAINTAIN ITS SHAPE, RAISING SUSPICION OF A LEAK. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

Additional Manufacturer Narrative

D4 ¿ EXPIRATION DATE ¿ ADDED D4 ¿ GTIN ¿ UPDATED D9 - PRODUCT AVAILABLE TO STRYKER - UPDATED D9 - RETURNED TO MANUFACTURER ON ¿ UPDATED H3 - DEVICE EVALUATED BY MFG ¿ UPDATED H4 ¿ MANUFACTURING DATE - ADDED THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, NO NOTABLE VISUAL ANOMALIES WERE NOTED TO THE DEVICE. AS A PART OF FUNCTIONAL INSPECTION AN ATTEMPT WAS MADE TO INFLATE THE BALLOON HOWEVER IT WAS NOTED TO BE LEAKING FROM THE MID-SECTION OF THE BALLOON, THE BALLOON WAS UNABLE TO BE INFLATED. THE REPORTED EVENT OF 'BALLOON FAILED TO INFLATE' AND 'BALLOON LEAK DURING USE' WERE CONFIRMED BASED ON THE DEVICE ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RECEIVED, BASED ON THE DAMAGE NOTED TO THE RETURNED DEVICE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. IT WAS REPORTED THAT A SUBJECT BALLOON CATHETER WAS PREPARED, FLUSHED PROPERLY, AND THEN DELIVERED TO THE TARGET SITE. UPON INFLATION AT THE LESION, THE BALLOON FAILED TO MAINTAIN ITS SHAPE, RAISING SUSPICION OF A LEAK. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE AND THE PATIENT'S ANATOMY WAS SEVERELY TORTUOUS. THE DEVICE WAS RETURNED AND THE DEVICE WAS CONFIRMED TO BE LEAKING AND UNABLE TO INFLATE. IT IS PROBABLE THAT THE DEVICE SUSTAINED DAMAGE DURING NAVIGATION THROUGH THE PATIENTS SEVERELY TORTUOUS ANATOMY, CAUSING IT TO LEAK DURING THE ATTEMPT TO INFLATE THE BALLOON. BASED ON REVIEW OF ALL AVAILABLE INFORMATION AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYZED EVENT OF 'BALLOON FAILED TO INFLATE' AND 'BALLOON LEAKED DURING USE', AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

Description of Event or Problem

THE BALLOON (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHEN THE SUBJECT BALLOON WAS PLACED AT TARGET LOCATION AND ATTEMPTED TO INFLATE THE BALLOON FAILED TO MAINTAIN ITS SHAPE, RAISING SUSPICION OF A LEAK. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.