Additional Manufacturer Narrative · 1
THE 2 FR SILICONE PICC WAS REPORTED TO HAVE ERODED THROUGH THE RIGHT BASILAR VEIN AFTER INDWELLING FOR FOUR DAYS. UTMD CONFIRMED WITH THE REPORTING HOSP THAT, IT WAS THE BASILICA VEIN IN THE ARM, NOT THE BASILAR VEIN IN THE BRAIN. UTMD WAS UNABLE TO LEARN OF THE NEONATE'S CONDITION FOLLOWING THE EVENT. THE CATHETER WAS NOT RETURNED FOR UTMD EVAL. THIS IS THE FIRST REPORT (TOGETHER WITH ANOTHER MEDWATCH FILED BY THE SAME INSTITUTION FOR A JUGULAR VEIN EROSION OCCURRING IN ANOTHER PT ON THE SAME DAY, IN WHICH A PICC FROM THE SAME LOT WAS INSERTED ON THE SAME DAY) OF VASCULAR EXCORIATION OR EROSION, SINCE, THE 2 FR SILICONE PICC WAS CLEARED FOR MARKETING UNDER 510(K) NUMBER K001874 IN 2000. THIS CONSTITUTES A "RARE" EVENT. REVIEWS OF UTMD'S AND SILICONE TUBING VENDOR'S DOCUMENTATION INDICATES NO CHANGES HAVE OCCURRED IN THE COMPOSITION OF THE MATERIAL OF THE CATHETER BODY. IN ADDITION, NO COMPLAINTS WHATSOEVER, HAVE BEEN RECEIVED BY UTMD TO DATE REGARDING 1345 CATHETERS ASSEMBLED AND SHIPPED TO CUSTOMERS FROM THE SAME LOT OF SILICONE TUBING. CLINICALLY, VASCULAR EROSION IS A RISK IN PICC PLACEMENTS, PARTICULARLY IN INSTANCES OF POOR INSERTION TECHNIQUE, MALPOSITIONING, OR INADEQUATE SECUREMENT LEADING TO MIGRATION; OR IN INSTANCES OF COMPROMISED NEONATAL CONDITION INCLUDING UNDERSIZED VASCULATURE RELATIVE TO THE SIZE OF THE CATHETER OR SEPSIS. PRODUCT NOT RETURNED.