MAHURKAR ELITE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B1, B2, B5, E1(FIRST NAME, LAST NAME, STREET 1, STREET 2, PHONE NUMBER), E2, E3, G3, H1, H6 NEW INFORMATION HAS BEEN RECEIVED PERTAINING TO THE EVENT. THIS EVENT HAS BEEN REASSESSED AND THE REPORTABILITY HAS BEEN DETERMINED TO BE A SERIOUS INJURY. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, AFTER INSERTING THE NEEDLE INTO THE VEIN AND INSERTING THE GUIDE WIRE, THE NEEDLE GOT STUCK IN THE GUIDE WIRE AND WAS NOT REMOVED. BOTH TWO KITS HAD THE SAME ISSUE AND WERE USED ON THE SAME PATIENT. BOTH KITS WERE OBSERVED DURING THE SAME EVENT. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. THE GUIDE WIRE WAS NEITHER FRAYED, COILED, NOR UNRAVELED. THE PUNCTURE NEEDLE WAS PROVIDED WITH THE KIT BEING USED. FLUSHING WAS DONE PRIOR TO USE, BUT THE RESULT WAS NOT PROVIDED. THE GUIDE WIRE WAS REMOVED AT THE SAME TIME AS THE NEEDLE, AND IT REMAINED INTACT WHEN REMOVED. THE KIT WAS REPLACED. THE PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS, BUT NO INFORMATION ON THE AMOUNT OF BLOOD LOST WAS PROVIDED, AND A BLOOD TRANSFUSION WAS REQUIRED. MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MOZARC MEDICAL CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED A GUIDEWIRE THAT HAD BEEN INSERTED INTO A PUNCTURE NEEDLE, WITH VISIBLE SIGNS OF USE. WHEN REMOVING THE GUIDEWIRE FROM THE PUNCTURE NEEDLE, ABNORMAL RESISTANCE WAS FELT, AND BIOLOGICAL TISSUE WAS SPOTTED. IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT BE WITHDRAWN. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS NOT TRACED TO THE DEVICE BUT RATHER TO BIOLOGICAL OBSTRUCTION. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MOZARC MEDICAL QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

CORRECTION: H3 H3 EVALUATION SUMMARY: MOZARC MEDICAL CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT BE WITHDRAWN. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MOZARC MEDICAL QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, AFTER INSERTING THE NEEDLE INTO THE VEIN AND INSERTING THE GUIDE WIRE, THE NEEDLE GOT STUCK IN THE GUIDE WIRE AND WAS NOT REMOVED. THIS WAS OBSERVED IN BOTH OF THE TWO (2) KITS. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

D10 - CONCOMITANT PRODUCT: 8888222220 12FR 20CM ELITE CURV DL KIT, 8888222220, LOT: 2127300074, 8888222220 12FR 20CM ELITE CURV DL KIT, 8888222220, LOT: 2127300074, MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.