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Patient 1
THIS ARTICLE WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY, AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS CORDIS BIOPSY FORCEPS BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. THE CITATION IS AS FOLLOWS: AMITAI ET AL. (2007). "COMPARISON OF THREE-DIMENSIONAL ECHOCARDIOGRAPHY TO TWO-DIMENSIONAL ECHOCARDIOGRAPHY AND FLUOROSCOPY FOR MONITORING OF ENDOMYOCARDIAL BIOPSY." THE AMERICAN JOURNAL OF CARDIOLOGY. AM J CARDIOL; 99: 64 ? 866, DOI: 10.1016/J.AMJCARD.2006.10.050. AS REPORTED IN THE LITERATURE ARTICLE BY AMITAI ET AL., (2007). "COMPARISON OF THREE-DIMENSIONAL ECHOCARDIOGRAPHY TO TWO-DIMENSIONAL ECHOCARDIOGRAPHY AND FLUOROSCOPY FOR MONITORING OF ENDOMYOCARDIAL BIOPSY." THE AMERICAN JOURNAL OF CARDIOLOGY. AM J CARDIOL; 99: 864 ? 866, DOI: 10.1016/J.AMJCARD.2006.10.050; DURING AN ENDOMYOCARDIAL BIOPSY (EMB) PROCEDURE USING CORDIS DISPOSABLE BIOPTOMES, ONE CLINICAL COMPLICATION OCCURRED WITH DOCUMENTED PERFORATION THAT RESULTED IN CARDIAC TAMPONADE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD (DHR) REVIEWS COULD NOT BE PERFORMED. GIVEN THE LIMITED INFORMATION PROVIDED, THE REPORTED EVENTS ?PERFORATION? AND ?CARDIAC TAMPONADE? COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), 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 AND ARE LISTED ON THE IFU. 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. CARDIAC TAMPONADE IS A SERIOUS MEDICAL CONDITION IN WHICH BLOOD OR FLUIDS FILL THE SPACE BETWEEN THE SAC THAT ENCASES THE HEART AND THE HEART MUSCLE. THIS PLACES EXTREME PRESSURE ON YOUR HEART. THE PRESSURE PREVENTS THE HEART'S VENTRICLES FROM EXPANDING FULLY AND KEEPS YOUR HEART FROM FUNCTIONING PROPERLY. VESSEL PERFORATION MAY CAUSE CARDIAC TAMPONADE, AS WAS REPORTED IN THIS CASE. ADDITIONALLY, VESSEL CHARACTERISTICS AND PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. WITHOUT A LOT NUMBER TO CONDUCT A DHR 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE SAME LITERATURE ARTICLE AND THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 1016427-2019-02680.