BIOPSY FORCEP

Description of Event or Problem

AS REPORTED, A 5.5F 50CM STANDARD (STD) BIOPSY FORCEPS BECAME "STUCK" IN A PATIENT'S ANASTOMOSIS SITE DURING THE ENDOMYOCARDIAL BIOPSY (EMB) PART OF THE PROCEDURE. THE PHYSICIAN WAS NOT ABLE TO FREE THE DEVICE AND AFTER SEVERAL ATTEMPTS WITH MULTIPLE DIFFERENT TECHNIQUES, THE PATIENT HAD TO GO TO THE OPERATING ROOM TO HAVE THE DEVICE REMOVED. IT WAS REPORTED THAT THE INCIDENT WAS NOT FATAL. IT WAS NOT DETERMINED IF THIS WAS A DEVICE FAILURE OR IF THE PATIENT'S ANATOMY WAS THE CAUSE OF THE INCIDENT. THE PHYSICIAN HISTORICALLY SHAPED THE FORCEPS WITH A SLIGHT CURVE TO FAVOR THE ANGLE OF ENTRY INTO THE RIGHT VENTRICLE, BUT THE EXTENT OF SHAPING OR RESHAPING FOR THIS PROCEDURE WAS NOT KNOWN. PRIOR TO THE INCIDENT THERE WERE NO REPORTED DIFFICULTIES OPENING OR CLOSING THE JAWS OF THE BIOPSY FORCEPS BECAUSE SAMPLES WERE OBTAINED BEFORE THE ISSUE OCCURRED. SAMPLES WERE SUCCESSFULLY TAKEN BEFORE THE DEVICE BECAME STUCK. THE PATIENT WAS A HEART TRANSPLANT PATIENT. THE INCIDENT OCCURRED DURING A RIGHT HEART CATHETERIZATION WITH ENDOMYOCARDIAL BIOPSY (EMB) PROCEDURE. DEVICE STORAGE, PREPARATION, AND USE ACCORDING TO THE INSTRUCTIONS FOR USE WERE DESCRIBED AS COMMON PRACTICE AT THE FACILITY. THE ACCESS SITE WAS THE RIGHT JUGULAR VEIN. THE OPERATOR WAS VERY WELL TRAINED ON THE DEVICE AND HAD EXTENSIVE EXPERIENCE WITH IT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION. LOT, MANUFACTURED DATE AND EXPIRATION DATE WILL REMAIN UNKNOWN, IF LOT INFORMATION IS RECEIVED, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.