NO MEDICAL RECORDS OR 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 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 PREPARATION, THE BEADING FROM THE VASCULAR GRAFT WAS ALLEGEDLY UNRAVELED. IT WAS FURTHER REPORTED THAT THE VASCULAR GRAFT WAS ALLEGEDLY TORN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
N
Patient 1
MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED, THE LOT MET ALL RELEASE CRITERIA. VISUAL INSPECTION: THE SAMPLE WAS BLOODY. AS THE REPORTED EVENT WAS REPORTED TO OCCUR DURING PREPARATION, THE BLOOD MOST LIKELY TRANSFERRED TO THE DEVICE. THE SEGMENTS RETURNED COULD NOT BE MEASURED FOR LENGTH DUE TO RETURNED CONDITION. THE FIRST SEGMENT IS THE SMALLER OF THE TWO RETURNED SEGMENTS. THE BEADING IS UNRAVELED FROM THE SEGMENTS AND IS TORN ALONG THE BEADING TRACK. THERE WERE NO SUTURE HOLES IDENTIFIED ALONG THE LENGTH OF THE RETURNED SEGMENT. THE SECOND SEGMENT CONSIST OF WHAT APPEARS TO BE THE REMAINDER OF THE GRAFT. THE BEADING IS UNRAVELED ALONG MOST OF THE LENGTH OF THE SEGMENT. THE GRAFT SEGMENT IS TORN IN A SPIRAL MANNER ALONG THE BEADING TRACK. REMNANTS OF EPTFE CAN BE IDENTIFIED ON THE REMOVED BEADING. THERE WERE NO SUTURE HOLES IDENTIFIED ALONG THE LENGTH OF THE RETURNED SEGMENT. FUNCTIONAL/PERFORMANCE EVALUATION: FUNCTIONAL TESTING IS NOT PREFORMED FOR THIS TYPE OF FAILURE. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: ONE DIGITAL PHOTO WAS REVIEWED. A GRAFT PRODUCT CAN BE IDENTIFIED WITHIN PACKAGING. ONE END OF THE GRAFT APPEARS TO BE TORN SPIRALLY ALONG THE BEADING TRACK. IT CAN NOT BE DETERMINED IF THE BEADING IS REMOVED FROM THE GRAFT. BASED ON THE IMAGE THE INVESTIGATION CAN BE CONFIRMED FOR TORN MATERIAL. CONCLUSION: THE DEVICE WAS RETURNED FOR EVALUATION. ONE PHOTO WAS ALSO PROVIDED FOR REVIEW. THE INVESTIGATION IS CONFIRMED FOR TORN MATERIAL, AS THE RETURNED DEVICE EXHIBITED SPIRAL TEARS ALONG THE LENGTH OF THE BEADING TRACK. LABELING REVIEW: THE CURRENT 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. (B)(4). 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 PREPARATION, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. THERE WAS NO PATIENT CONTACT.