N
Patient 1
NO MEDICAL RECORDS OR IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE HAS NOT BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN 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 A CLINICAL STUDY AFTER IMPLANTATION OF THE VASCULAR GRAFT IN A RIGHT UPPER ARM, THE PATIENT EXPERIENCED ALLEGED BLEEDING. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) DISCOVERED A HEMATOMA IN THE LEFT AXILLA WHICH COMPRESSED THE OUTFLOW OF THE GRAFT; THEREFORE, THE PATIENT WAS RETURNED TO SURGERY AND THE HEMATOMA WAS REMOVED. REPORTEDLY, THE VENOUS ANASTOMOSIS HAD TO BE TAKEN DOWN IN ORDER TO THROMBECTOMIZE THE GRAFT AND RESTORE THE OUTFLOW. FURTHERMORE, THE GRAFT WAS HEPARINIZED AND THE PATIENT WAS COMMENCED ON WARFARIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS POST INTERVENTION.
N
Patient 1
A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION LOT NUMBER WAS UNKNOWN. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, 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. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED. THERE WAS NO SPECIFIC DEFICIENCY ALLEGED. THE INVESTIGATION WAS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE WAS UNKNOWN. LABELING REVIEW: THE CURRENT INSTRUCTION FOR USE (IFU) STATES: ADVERSE REACTIONS POTENTIAL COMPLICATIONS WHICH MAY OCCUR WITH ANY SURGICAL PROCEDURE INVOLVING A VASCULAR PROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO: -DISRUPTION OR TEARING OF THE SUTURE LINE GRAFT, AND/OR HOST VESSEL; SUTURE HOLE BLEEDING; GRAFT REDUNDANCY; THROMBOSIS, EMBOLIC EVENTS, OCCLUSION OR STENOSIS; ULTRAFILTRATION; SEROMA FORMATION; SWELLING OF THE IMPLANTED LIMB; FORMATION OF HEMATOMA OR PSEUDOANEURYSM; INFECTION; ANEURYSM/DILATION; BLOOD LEAKAGE; HEMORRHAGE; STEAL SYNDROME; AND/OR SKIN EROSION. BLOOD ACCESS PROCEDURES LEAVE THE GRAFT IN PLACE FOR APPROXIMATELY TWO WEEKS PRIOR TO USE. THERE IS AN INCREASED RISK OF HEMATOMA FORMATION IF THE GRAFT IS PUNCTURED PRIOR TO COMPLETE HEALING. INSERT THE BLOOD ACCESS NEEDLE AT A 20? TO 45? ANGLE, WITH THE BEVEL UP. WHEN THE GRAFT IS PENETRATED, ADVANCE THE NEEDLE PARALLEL TO THE GRAFT. ROTATE (CHANGE) THE CANNULATION SITES. DO NOT REPEAT CANNULATION IN THE SAME AREA. REPEAT CANNULATION MAY LEAD TO FORMATION OF A HEMATOMA OR A PSEUDOANEURYSM. DO NOT CANNULATE WITHIN THE DIALYSIS NEEDLE?S LENGTH OF THE PROXIMAL AND DISTAL ANASTOMOSIS. STRICTLY ADHERE TO ASEPTIC TECHNIQUE TO MINIMIZE INFECTION. APPLY MODERATE DIGITAL PRESSURE TO THE CANNULATION SITE AFTER NEEDLE WITHDRAWAL. THIS COMPRESSION ASSISTS IN HEMOSTASIS. ADDITIONAL MFR NARRATIVE: DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY, CONCOMITANT MEDICAL PRODUCTS, REPORT SOURCE, DATE RECEIVED BY MFR. DEVICE EVALUATED BY MFR?, (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 A CLINICAL STUDY AFTER IMPLANTATION OF THE VASCULAR GRAFT IN A RIGHT UPPER ARM, THE PATIENT EXPERIENCED ALLEGED BLEEDING. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) DISCOVERED A HEMATOMA IN THE LEFT AXILLA WHICH COMPRESSED THE OUTFLOW OF THE GRAFT; THEREFORE, THE PATIENT WAS RETURNED TO SURGERY AND THE HEMATOMA WAS REMOVED. REPORTEDLY, THE VENOUS ANASTOMOSIS HAD TO BE TAKEN DOWN IN ORDER TO THROMBECTOMIZE THE GRAFT AND RESTORE THE OUTFLOW. FURTHERMORE, THE GRAFT WAS HEPARINIZED AND THE PATIENT WAS COMMENCED ON WARFARIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS POST INTERVENTION. NEW INFORMATION: IT WAS REPORTED THAT IN ADDITION TO THE PATIENT BEING COMMENCED ON WARFARIN, THE PATIENT WAS ALSO COMMENCED ON CLOPIDOGREL FOR PATENCY AS WELL AS OMACOR, IN ADDITION TO HIS PREVIOUS MEDICATIONS. IT WAS FURTHER REPORTED THAT POST SURGERY, THRILL AND BRUIT WERE PRESENT, AND THE PATIENT EXPERIENCED ALLEGED AUDIBLE WHEEZING WITH RESPIRATIONS OF 28 PER MINUTE. THE PATIENT WAS REPORTED TO BE TREATED WITH ALBUTEROL AND ATROVENT, GIVEN VIA NEBULIZER. IT WAS ALSO REPORTED THAT POST-OPERATIVE NAUSEA AND VOMITING WERE TREATED; IV HEPARIN WAS CONTINUED FOR A COUPLE OF DAYS; AND INTRAVENOUS VANCOMYCIN WAS INITIATED FOR PROPHYLACTIC COVERAGE FOLLOWING CONDUIT PLACEMENT, WHICH WAS TO BE ADMINISTERED POST DIALYSIS. ON (B)(6) 2016 THE PATIENT RECEIVED DIALYSIS; HIS IV HEPARIN WAS DISCONTINUED, AND HE WAS PLACED ON A TREATMENT DOSE OF ENOXAPARIN FOR HOME ADMINISTRATION UNTIL HIS INR WAS THERAPEUTIC. ON THE SAME DAY, HE WAS EXAMINED AND WAS DISCHARGED HOME WITH A WORKING GRAFT. INSTRUCTIONS WERE GIVEN TO FOLLOW UP WITH A DUPLEX SCAN WITHIN SEVEN TO FIFTEEN DAYS. THE EVENT WAS REPORTED AS RESOLVED ON THE SAME DAY.
N
Patient 1
MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION LOT NUMBER WAS UNKNOWN. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, 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. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED. THERE WAS NO SPECIFIC DEFICIENCY ALLEGED. THE INVESTIGATION WAS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE WAS UNKNOWN. LABELING REVIEW: THE CURRENT INSTRUCTION FOR USE (IFU) STATES: ADVERSE REACTIONS POTENTIAL COMPLICATIONS WHICH MAY OCCUR WITH ANY SURGICAL PROCEDURE INVOLVING A VASCULAR PROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO: -DISRUPTION OR TEARING OF THE SUTURE LINE GRAFT, AND/OR HOST VESSEL; SUTURE HOLE BLEEDING; GRAFT REDUNDANCY; THROMBOSIS, EMBOLIC EVENTS, OCCLUSION OR STENOSIS; ULTRAFILTRATION; SEROMA FORMATION; SWELLING OF THE IMPLANTED LIMB; FORMATION OF HEMATOMA OR PSEUDOANEURYSM; INFECTION; ANEURYSM/DILATION; BLOOD LEAKAGE; HEMORRHAGE; STEAL SYNDROME; AND/OR SKIN EROSION. BLOOD ACCESS PROCEDURES LEAVE THE GRAFT IN PLACE FOR APPROXIMATELY TWO WEEKS PRIOR TO USE. THERE IS AN INCREASED RISK OF HEMATOMA FORMATION IF THE GRAFT IS PUNCTURED PRIOR TO COMPLETE HEALING. INSERT THE BLOOD ACCESS NEEDLE AT A 20? TO 45? ANGLE, WITH THE BEVEL UP. WHEN THE GRAFT IS PENETRATED, ADVANCE THE NEEDLE PARALLEL TO THE GRAFT. ROTATE (CHANGE) THE CANNULATION SITES. DO NOT REPEAT CANNULATION IN THE SAME AREA. REPEAT CANNULATION MAY LEAD TO FORMATION OF A HEMATOMA OR A PSEUDOANEURYSM. DO NOT CANNULATE WITHIN THE DIALYSIS NEEDLE?S LENGTH OF THE PROXIMAL AND DISTAL ANASTOMOSIS. STRICTLY ADHERE TO ASEPTIC TECHNIQUE TO MINIMIZE INFECTION. APPLY MODERATE DIGITAL PRESSURE TO THE CANNULATION SITE AFTER NEEDLE WITHDRAWAL. THIS COMPRESSION ASSISTS IN HEMOSTASIS. 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 A CLINICAL STUDY AFTER IMPLANTATION OF THE VASCULAR GRAFT IN A LEFT UPPER ARM, THE PATIENT EXPERIENCED ALLEGED BLEEDING. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) DISCOVERED A HEMATOMA IN THE LEFT AXILLA WHICH COMPRESSED THE OUTFLOW OF THE GRAFT; THEREFORE, THE PATIENT WAS RETURNED TO SURGERY AND THE HEMATOMA WAS REMOVED. REPORTEDLY, THE VENOUS ANASTOMOSIS HAD TO BE TAKEN DOWN IN ORDER TO THROMBECTOMIZE THE GRAFT AND RESTORE THE OUTFLOW. FURTHERMORE, THE GRAFT WAS HEPARINIZED AND THE PATIENT WAS COMMENCED ON WARFARIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS POST INTERVENTION. NEW INFORMATION: IT WAS REPORTED THAT IN ADDITION TO THE PATIENT BEING COMMENCED ON WARFARIN, THE PATIENT WAS ALSO COMMENCED ON CLOPIDOGREL FOR PATENCY AS WELL AS OMACOR, IN ADDITION TO HIS PREVIOUS MEDICATIONS. IT WAS FURTHER REPORTED THAT POST SURGERY, THRILL AND BRUIT WERE PRESENT, AND THE PATIENT EXPERIENCED ALLEGED AUDIBLE WHEEZING WITH RESPIRATIONS OF 28 PER MINUTE. THE PATIENT WAS REPORTED TO BE TREATED WITH SALBUTEROL AND ATROVENT, GIVEN VIA NEBULIZER. IT WAS ALSO REPORTED THAT POST-OPERATIVE NAUSEA AND VOMITING WERE TREATED; IV HEPARIN WAS CONTINUED FOR A COUPLE OF DAYS; AND INTRAVENOUS VANCOMYCIN WAS INITIATED FOR PROPHYLACTIC COVERAGE FOLLOWING GRAFT PLACEMENT, WHICH WAS TO BE ADMINISTERED POST DIALYSIS. ON (B)(6) 2016 THE PATIENT RECEIVED DIALYSIS; HIS IV HEPARIN WAS DISCONTINUED, AND HE WAS PLACED ON A TREATMENT DOSE OF ENOXAPARIN FOR HOME ADMINISTRATION UNTIL HIS INR WAS THERAPEUTIC. ON THE SAME DAY, HE WAS EXAMINED AND WAS DISCHARGED HOME WITH A WORKING GRAFT. INSTRUCTIONS WERE GIVEN TO FOLLOW UP WITH A DUPLEX SCAN WITHIN SEVEN TO FIFTEEN DAYS. THE EVENT WAS REPORTED AS RESOLVED ON THE SAME DAY.