MAHURKAR

Description of Event or Problem

ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PATIENT UNDERWENT SIX HOURS OF HEMODIALYSIS FOR UREMIA. DUE TO THE PATIENT'S INTERMITTENT AGITATION, THE PATIENT¿S LEG SUDDENLY RAISED, CAUSING THE FIXATION WING OF THE FEMORAL VEIN CATHETER TO BE TORN BY SUTURES, RESULTING IN CATHETER DISPLACEMENT. EXAMINATION BY MEDICAL STAFF REVEALED NO BLEEDING AT THE INSERTION SITE, THE SUTURES REMAINED INTACT, AND THE PATIENT'S SKIN WAS UNHARMED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. AS A REMEDIAL ACTION AND INTERVENTION, AFTER MEDICAL ASSESSMENT, THE NURSING STAFF REMOVED THE FEMORAL VEIN CATHETER. THE FOLLOWING DAY, AFTER ESTABLISHING A NEW HEMODIALYSIS ACCESS, TREATMENT WAS CONTINUED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

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.