MAHURKAR

Description of Event or Problem

ACCORDING TO THE REPORTER, ON THE EVENT DAY, DURING THE DIALYSIS SESSION, THE PHYSICIAN OBSERVED INADEQUATE BLOOD FLOW FROM THE CATHETER, RESULTING IN INSUFFICIENT DIALYSIS, AND TEGO WAS NOT UTILIZED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY CONTINUOUS REPOSITIONING OF THE CATHETER, WHICH WAS TIME-CONSUMING AND INCREASED THE WORKLOAD OF THE MEDICAL STAFF, LEADING TO PATIENT DISCOMFORT AND ANXIETY. A REPAIR KIT WAS NOT USED. THERE WAS NO BLOOD TRANSFUSION REQUIRED DUE TO THE EVENT. 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.