NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION 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. THERE WAS NO REPORTED PATIENT INJURY.
N
Patient 1
MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THE LOT MET ALL RELEASE CRITERIA. THE DHR REVIEW SHOWED THAT ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION AND THAT THIS LOT OF GRAFTS PASSED ALL PHYSICAL TESTING REQUIREMENTS. THERE WAS NO EVIDENCE OF ANY DEFICIENCIES WITHIN THE LOT THAT WOULD CONTRIBUTE TO THIS COMPLAINT. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, A VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT RETURNED; THEREFORE, FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THE INVESTIGATION WAS INCONCLUSIVE FOR TORN MATERIAL. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT WAS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. 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. THERE WAS NO REPORTED PATIENT INJURY.