JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 7F X 50CM MAXI-CURVED

Additional Manufacturer Narrative

SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Description of Event or Problem

"ON MY LAST PASS FOR BIOPSIES UNDER ECHO GUIDANCE THE BIOPTOME GOT STUCK IN PRESUMABLY THE RV, AND I WAS UNABLE TO PULL IT BACK WITHOUT SIGNIFICANT RESISTANCE AND COULD NOT OPEN THE JAWS OR MANEUVER IT MUCH. THE PATIENT WENT INTO AN SVT AND FELT VERY UNCOMFORTABLE. DUE TO HER ARRHYTHMIA AND DISCOMFORT, I PULLED THE BIOPTOME WITH SIGNIFICANT TENSION NOTED AT THE TIME AND RETRIEVED A FAIRLY LARGE PIECE OF TISSUE ON THE END THOUGH THE JAWS REMAINED SHUT AND I COULD NOT RELEASE THE TISSUE PIECE. THAT IS STILL ATTACHED TO THE BIOPTOME AND THE DEVICE WAS COLLECTED TO SEND TO THE MANUFACTURER. THE PATIENT IMMEDIATELY FLIPPED OUT OF HER SVT RHYTHM, FELT BETTER AND REMAINED HEMODYNAMICALLY STABLE."

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. IFU UNDER PRECAUTIONS- "THE FORCEP SHOULD BE THOROUGHLY RINSED WITH HEPARINIZED SALINE PRIOR TO EACH SPECIMEN COLLECTION DURING THE PROCEDURE." ONE OPENED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WOULD NOT ACTUATE WHEN RECEIVED AND ACTUATING WIRE WAS BENT IN THE HANDLE. DISTAL END OF DEVICE WAS SOAKED FOR FIFTEEN MINUTES IN ALCOHOL AND REMOVED. DEVICE WOULD THEN SLIGHTLY START TO OPEN UPON ACTUATION. JAW WAS MANIPULATED OPEN AND THEN THE DEVICE WAS SOAKED AGAIN AND PERIODICALLY ACTUATED. AFTER FINAL REMOVAL FROM ALCOHOL SOAK, THE DEVICE WOULD ACTUATE. ROOT CAUSE OF THE DEVICE NOT WORKING PROPERLY IS MOST LIKELY A FOREIGN SUBSTANCE(ORGANIC) CAUGHT IN THE CLEVIS AREA MECHANISM OF THE DISTAL TIP(JAWZ). A RESULT OF THE DEVICE NOT BEING THOROUGHLY RINSED. SINCE THIS ISSUE WAS BELIEVED TO BE CAUSED BY THE USER NOT THOROUGHLY RINSING WITH HEPARINIZED SALINE, NO CORRECTIVE ACTION IS NECESSARY. THE IFU HAS BEEN RECENTLY UPDATED TO FURTHER STRESS THE IMPORTANCE OF CLEANING THE DEVICE UPON REMOVAL.

Description of Event or Problem

"ON MY LAST PASS FOR BIOPSIES UNDER ECHO GUIDANCE THE BIOPTOME GOT STUCK IN PRESUMABLY THE RV, AND I WAS UNABLE TO PULL IT BACK WITHOUT SIGNIFICANT RESISTANCE AND COULD NOT OPEN THE JAWS OR MANEUVER IT MUCH. THE PATIENT WENT INTO AN SVT AND FELT VERY UNCOMFORTABLE. DUE TO HER ARRHYTHMIA AND DISCOMFORT, I PULLED THE BIOPTOME WITH SIGNIFICANT TENSION NOTED AT THE TIME AND RETRIEVED A FAIRLY LARGE PIECE OF TISSUE ON THE END THOUGH THE JAWS REMAINED SHUT AND I COULD NOT RELEASE THE TISSUE PIECE. THAT IS STILL ATTACHED TO THE BIOPTOME AND THE DEVICE WAS COLLECTED TO SEND TO THE MANUFACTURER. THE PATIENT IMMEDIATELY FLIPPED OUT OF HER SVT RHYTHM, FELT BETTER AND REMAINED HEMODYNAMICALLY STABLE".

Additional Manufacturer Narrative

SAMPLE IS NOT AVAILABLE FOR RETURN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Description of Event or Problem

"ON MY LAST PASS FOR BIOPSIES UNDER ECHO GUIDANCE THE BIOPTOME GOT STUCK IN PRESUMABLY THE RV, AND I WAS UNABLE TO PULL IT BACK WITHOUT SIGNIFICANT RESISTANCE AND COULD NOT OPEN THE JAWS OR MANEUVER IT MUCH. THE PATIENT WENT INTO AN SVT AND FELT VERY UNCOMFORTABLE. DUE TO HER ARRHYTHMIA AND DISCOMFORT, I PULLED THE BIOPTOME WITH SIGNIFICANT TENSION NOTED AT THE TIME AND RETRIEVED A FAIRLY LARGE PIECE OF TISSUE ON THE END THOUGH THE JAWS REMAINED SHUT AND I COULD NOT RELEASE THE TISSUE PIECE. THAT IS STILL ATTACHED TO THE BIOPTOME AND THE DEVICE WAS COLLECTED TO SEND TO THE MANUFACTURER. THE PATIENT IMMEDIATELY FLIPPED OUT OF HER SVT RHYTHM, FELT BETTER AND REMAINED HEMODYNAMICALLY STABLE".