NO DEVICE, NO MEDICAL RECORDS, OR NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. REPORTEDLY, ANOTHER VASCULAR GRAFT WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
N
Patient 1
MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED, THE LOT MET ALL RELEASE CRITERIA. VISUAL INSPECTION: THE SAMPLE WAS NOT PROVIDED; THEREFORE, A VISUAL COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT PROVIDED; THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: TWO DIGITAL PHOTOS WERE REVIEWED. THE FIRST PHOTO SHOWS ONE GRAFT WHICH APPEARS TO HAVE ONE END CLAMPED INTO LOCATION. THE OTHER END OF THE GRAFT DOES NOT LOOK TO BE SECURED. TWO BLUE LINES CAN BE IDENTIFIED RUNNING DOWN THE LENGTH OF THE GRAFT SHOWN IN THE PHOTO IDENTIFYING THE GRAFT AS A BARD GRAFT. A TEAR CAN BE SEEN IN AN AREA TO WHICH THE BEADING HAS BEEN REMOVED. THE SECOND PHOTO SHOWS WHAT APPEARS TO BE A FULLY IMPLANTED GRAFT. TWO BLUE LINES CAN BE IDENTIFIED RUNNING DOWN THE LENGTH OF THE GRAFT SHOWN IN THE PHOTO IDENTIFYING THE GRAFT AS A BARD GRAFT. NO CLEAR TEAR CAN BE LOCATED ALONG THE LENGTH OF THE EXPOSED GRAFT. BASED ON THE PHOTO REVIEW THE INVESTIGATION IS CONFIRMED FOR TORN MATERIAL. CONCLUSION: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. TWO DIGITAL PHOTOS WERE RETURNED AND REVIEWED. BASED ON THE PROVIDED PHOTOS, THE INVESTIGATION CAN BE CONFIRMED FOR TORN MATERIAL AS A TEAR IN THE GRAFT CAN BE IDENTIFIED ALONG THE BEADING TRACK. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: PRECAUTIONS - WHEN REMOVING THE EXTERNAL SPIRAL SUPPORT (BEADING) OF THE GRAFT, THE BEADING MUST BE REMOVED SLOWLY AND AT A 90? ANGLE TO THE GRAFT. RAPID UNWINDING AND /OR REMOVAL AT LESS THAN A 90? ANGLE MAY RESULT IN GRAFT DAMAGE. DO NOT USE SURGICAL BLADES OR SHARP, POINTED INSTRUMENTS TO REMOVE THE BEADING AS THIS MAY DAMAGE THE GRAFT WALL. IF DAMAGE OCCURS, THAT SEGMENT OF THE GRAFT SHOULD NOT BE USED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. REPORTEDLY, ANOTHER VASCULAR GRAFT WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.