TRANSFORM SUPER COMPLIANT 4MM X 10MM- CE

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MES SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. ON VISUAL/MICROSCOPIC INSPECTION IT WAS NOTED THAT THE BALLOON HAD BEEN SHEARED OFF AND THE LDPE/LLDPE TUBING JAGGED AS. DRIED CRYSTALIZED PROCEDURAL FLUID WAS ALSO PRESENT. A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED DUE TO DAMAGE TO THE 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. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATION WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALY NOTED TO THE DEVICE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THERE WERE NO ANOMALIES NOTED TO THE DEVICE PRIOR TO USE, CONTINUOUS FLUSH WAS MAINTAINED AND THE LUMEN OF THE CATHETER WAS FLUSHED THROUGH WITH HEPARINIZED SALINE. THE BALLOON CATHETER SYSTEM WAS USED AS PER DFU AND THE BALLOON INFLATED/DEFLATED DURING PREP. THE CORRECT AMOUNT OF INFLATION MEDIA WAS USED TO INFLATE THE BALLOON, 50% CONTRAST - 50% SALINE WAS USED DURING PREPARATION AND PROCEDURE. THERE WAS NO LEAKAGE NOTED DURING PREPARATION AND THE MATERIAL WAS PREPARED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS FOR USE. THE BALLOON WAS INSIDE THE PATIENT WHEN INFLATION ISSUE OCCURRED. THE TIP OF THE GUIDEWIRE WAS APPROXIMATELY 2-3CM TO THE DISTAL PART OF THE BALLOON IN RELATION TO THE TIP OF THE BALLOON CATHETER. THE PATIENT¿S ANATOMY WAS A LITTLE TORTUOUS. THE ANATOMY LOCATION WAS THE RIGHT INTERNAL CAROTID, SUPERIOR PITUITARY ARTERY WHEN THE BALLOON DID NOT INFLATE. PRODUCT ANALYSIS FOUND THE BALLOON HAD BEEN SHEARED OFF AND THE LDPE/LLDPE TUBING WAS JAGGED WHICH INDICATES THE DEVICE ENCOUNTERED A SIGNIFICANT MANIPULATION DURING PREPARATION. THE REPORTED EVENT WAS CONFIRMED DURING PRODUCT ANALYSIS. THE AS REPORTED ¿BALLOON FAILED TO INFLATE¿ AND AS ANALYZED ¿BALLOON DETACHED/SEPARATED¿ AND ¿BALLOON DAMAGED' WILL BE ASSIGNED PROCEDURAL FACTORS AS THESE DEFECTS APPEAR TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL OR ANATOMICAL FACTORS DURING USE.

Description of Event or Problem

THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT SUBJECT BALLOON WAS DETACHED/SEPARATED. THE SUBJECT BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.