BIOPSY FORCEP

Additional Manufacturer Narrative

LOT #, CATALOG #, EVENT DATE UNKNOWN AS THIS IS A SURVEY COMPLAINT. AS REPORTED IN BIOPSY FORCEPS SURVEY THE RESPONDENT EXPERIENCED INFECTION. 14 DAYS POST IN IMMUNOCOMPROMISED PATIENT. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED IF THE EVENT ¿INFECTION¿ IS MANUFACTURING RELATED. INFECTION IS A KNOWN COMPLICATION DURING MYOCARDIAL BIOPSIES AND IS DOCUMENTED IN THE IFU AS SUCH. HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿PROCEDURES REQUIRING BIOPSY FORCEPS SHOULD NOT BE ATTEMPTED BY PHYSICIANS UNFAMILIAR WITH THE POSSIBLE COMPLICATIONS. COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: ARTERIOVENOUS FISTULA FORMATION, BLEEDING AND/OR HEMATOMA AT THE PUNCTURE SITE, DEATH, EMBOLISM, INFECTION, LESIONS OF THE TRICUSPID VALVE, NERVE INJURY, PERFORATION OF THE VESSEL WALL OR THE MYOCARDIUM, PNEUMOTHORAX, THROMBOSIS, VARIOUS TYPES OF ARRYTHMIAS, VESSEL TRAUMA¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

AS REPORTED, IN THE BIOPSY FORCEPS SURVEY, THE RESPONDENT #32 EXPERIENCED INFECTION. THIS OCCURRED 14 DAYS POST IN IMMUNOCOMPROMISED PATIENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.