Additional Manufacturer Narrative · 1
THE PRODUCT RECEIVED FOR EVALUATION IS A DUAL LUMEN PORT WITH A PRE-ATTACHED SEGMENT OF 10.0 FR. CATHETER. THE COMPLETE ASSEMBLY MEASURES 4.1 INCHES LONG. THE DISTAL TIP OF THE CATHETER HAS TORN EDGES AND A PERMANENTLY FLATTENED OUTER DIAMETER. VIEWING THE PORT FROM THE TOP WITH THE STEM POINTING TOWARD THE EXAMINER, THE OUTER DIAMETER OF THE RIGHT LUMEN PROTRUDES APPROXIMATELY .1 INCH BEYOND THE LEFT LUMEN OUTER DIAMETER AND THE WEB WALL. AS THE CATHETER EXITS THE STRAIN RELIEF IT ANGLES MODERATELY TO THE RIGHT UNTIL THE DISTAL TIP IS APPROXIMATELY 1.25 INCHES OFF CENTER-LINE. A LOT HISTORY REVIEW IS NOT POSSIBLE AS NO PRODUCT OR LOT NUMBERS ARE PROVIDED. EXCEPT FOR AN INDETERMINATE NUMBER OF NEEDLE PUNCTURE SITES IN BOTH SEPTUMS, 5X MAGNIFICATION OF THE PORT IS UNREMARKABLE. MICROSCOPIC EXAM (10X) OF THE CATH-LOCK REVEAL LIGHT IMPRESSIONS IN THE PLASTIC CATH-LOCK. THESE IMPRESSIONS ARE FOUND ON BOTH THE INFERIOR AND SUPERIOR ASPECTS OF THE CATH-LOCK AND ARE EVIDENCE OF USING HEMOSTATS OR SIMILARLY TRAUMATIC CLAMPS WHILE MANIPULATING THE PORT. UNDER 15X MAGNIFICAITON, THE EDGES OF THE CATHETER'S DISTAL TIP APPEAR RAGGED AND UNEVEN. A SHORT CRACK IN THE OUTER DIAMETER FOLLOWS THE WEB WALL ALONG ONE SIDE. THE DISTAL TIP FACE IS BROKEN AND GRANULAR. THE INNER SURFACE OF THE PROTRUDING FLAP CONTAINS AREAS THAT ARE SMOOTH AND WORN. A MICROSCOPIC MICROMETER IS USED TO MEASURE THE FLATTENED DISTAL TIP. THE LONG AXIS IS .138 INCHES AND THE SHORT AXIS IS .080 INCHES (ROUND TUBING AVERAGES .125 INCHES IN OD). THIS TYPE OF DISTAL TIP DAMAGE IS EVIDENCE OF TUBING FAILURE RESULTING FROM CLAVICULAR/FIRST RIB COMPRESSION. TACTUAL EXAM OF THE CATHETER IS UNREMARKABLE. PATENCY TO FLUSHING AND ASPIRATION IS ESTABLISHED BY FLUSHING EACH SEPTUM/LUMEN WITH A WATER-FILLED 12CC SYRINGE FITTED WITH A 19GA. NON-CORING NEEDLE. NO LEAKS ARE NOTED WHEN OCCLUDING THE CATHETER AND HYDRAULICALLY PRESSURIZING EACH SEPTUM TO A SUSTAINED PRESSURED > 25 PSI. THE COMPLAINT OF CATHETER BREAKAGE IS CONFIRMED. THE FLATTENED, OVAL SHAPE OF THE DISTAL TIP IS CONSISTENT WITH A CLAVICLE/FIRST RIB COMPRESSION FRACTURE. THIS IS A COMPLICATION ASSOCIATED WITH THE MEDICAL PLACEMENT OF THE CATHETER IN THE SUBCLAVIAN VEIN. THE INFERIOR ASPECT OF THE CLAVICLE COMPRESSES THE CATHETER TUBING WITH A SCISSORING ACTION AGAINST THE SUPERIOR SURFACE OF THE FIRST RIB UNTIL THE TUBING FAILS. THE SEVERED END OF THE TUBING IS THEN FREE TO TRAVEL WITH THE BLOOD FLOW TOWARD THE HEART. THE PRODUCT INSTRUCTIONS FOR USE CAUTIONS THE USER REGARDING THIS RISK.