UNKNOWN BIOPSY FORCEPS

Additional Manufacturer Narrative

COMPLAINT CONCLUSION: AS REPORTED IN THE SURVEY RESPONSES FOR BI-PAL, A PHYSICIAN COMMENTED ¿VERY HAPPY WITH ITS CHARACTERISTICS. I HAVE REMEMBERED JUST ONE CASE OF PERFORATION IN 24 YEARS.¿ THE USER¿S SPECIALTY IS INTERVENTIONAL CARDIOLOGY. HE/SHE HAS USED FIFTEEN BI-PAL BIOPSY FORCEPS DEVICES WITHIN THE LAST YEAR, AND THE MOST COMMONLY USED LENGTH WAS 104CM. THE PHYSICIAN ALSO USES THE FEMORAL ACCESS SITE 100% OF THE TIME WHEN USING THE BI-PAL DEVICES. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, PRODUCT HISTORY RECORD (PHR) REVIEWS COULD NOT BE PERFORMED. WITHOUT THE RETURN OF THE DEVICE OR PROCEDURAL IMAGES, THE REPORTED ¿VESSEL PERFORATION¿ CANNOT BE CONFIRMED AND THE EXACT ROOT CAUSE CANNOT BE DETERMINED. PROCEDURAL/HANDLING FACTORS OR USER TECHNIQUE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, THE INSTRUCTIONS FOR USE (IFU) PRECAUTIONS, ¿IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE FORCEPS.¿ THE RECOMMENDED PROCEDURE STATES, ¿THESE BIOPSY FORCEPS ARE FORMABLE AT THE TIP. TO MODIFY THE ANGLE OF THE EXISTING CURVE, GRASP THE DISTAL END BETWEEN THE THUMB AND INDEX FINGER. SLIDE FINGERS ALONG TIP WHILE BENDING TO DESIRED ANGLE. REFER TO THE ¿DESCRIPTION¿ SECTION FOR AID IN SELECTING THE SIZE OF THE SHEATH INTRODUCER AND BIOPSY FORCEPS TO BE USED. USING FLUOROSCOPY, ADVANCE THE FORCEPS THROUGH THE APPROPRIATE SHEATH INTRODUCER AND INTO THE RIGHT OR LEFT VENTRICLE. AFTER CONFIRMING THAT THE TIP OF THE FORCEPS IS IN THE VENTRICLE, OPEN THE JAWS. ADVANCE THE OPEN JAWS TO THE HEART WALL. CLOSE THE JAWS FIRMLY TO OBTAIN A TISSUE SPECIMEN. MAINTAIN SUFFICIENT PRESSURE ON THE DOUBLE RINGS TO ASSURE RETENTION OF SPECIMEN DURING WITHDRAWAL. NOTE: CLOSING OF THE JAWS AND WITHDRAWAL OF THE BIOPTOME SHOULD BE PERFORMED IN A SINGLE MOTION. FLUSH THE SHEATH INTRODUCER CONTINUOUSLY WITH HEPARINIZED SALINE WHILE SLOWLY WITHDRAWING THE FORCEPS. REMOVE THE SAMPLE FROM JAWS.¿ ¿COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: HEMATOMA AT THE PUNCTURE SITE, INFECTION, PERFORATION OF THE VESSEL WALL OR THE MYOCARDIUM, VESSEL TRAUMA, EMBOLISM, AND DEATH.¿ WITHOUT A LOT NUMBER TO CONDUCT A PHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

AS REPORTED IN THE SURVEY RESPONSES FOR BI-PAL, A PHYSICIAN IN SPAIN COMMENTED ¿VERY HAPPY WITH ITS CHARACTERISTICS. I HAVE REMEMBERED JUST ONE CASE OF PERFORATION IN 24 YEARS.¿ THE ONLY OTHER RELEVANT INFORMATION PROVIDED IN THIS SURVEY BY THE USER IS THAT HIS/HER SPECIALTY IS INTERVENTIONAL CARDIOLOGY WITH 24 YEARS IN PRACTICE POST-RESIDENCY, AND MAJORITY OF THE TIME, THE USER IS AT AN ACADEMIC MEDICAL CENTER. HE/SHE HAS USED FIFTEEN (15) BI-PAL BIOPSY FORCEPS DEVICES WITHIN THE LAST YEAR, AND THE MOST COMMONLY USED LENGTH WAS 104CM. THE PHYSICIAN ALSO USES THE FEMORAL ACCESS SITE 100% OF THE TIME WHEN USING THE BI-PAL DEVICES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.