PALINDROME

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3. CORRECTION: B5, H6. 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, THERE WAS A GUIDE WIRE DEFECT WITH A FUNCTIONING CENTRAL VENOUS CATHETER (CVC). THIS WAS A CENTRAL VENOUS CATHETER PLACEMENT FOR DIALYSIS IN THE RIGHT JUGULAR VEIN, A ONE-HOUR PROCEDURE. ONCE THE VENIPUNCTURE WAS PERFORMED, THE GUIDE WIRE WAS INSERTED THROUGH THE NEEDLE, BUT THERE WAS NO MOVEMENT (NO SLIPPAGE), AND THE GUIDE WIRE GOT STUCK. THE GUIDEWIRE THAT WAS PROVIDED WITH THE KIT WAS USED. THIS WAS THE FIRST TIME THE DEVICE WAS USED. THE GUIDEWIRE WAS REMOVED BY HAND, AND IT WAS NECESSARY TO REMOVE THE GUIDEWIRE AND THE NEEDLE FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. EVERYTHING WAS REMOVED, REVEALING A BROKEN GUIDE WIRE (FRAYED). IT WAS ALSO STATED THAT WHEN REMOVED, THE GUIDEWIRE WAS SPIRAL BUT NOT BROKEN, AND THERE WAS NO RESIDUE ON THE PATIENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE ON THE CATHETER WITH NO PROBLEM. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE GUIDEWIRE WAS CHANGED. THE PROCEDURE WAS COMPLETED, AND THE REPORTED CATHETER WAS IMPLANTED ON THE SAME DAY OF THE EVENT. THE OPERATOR REPORTED THE INCIDENT TO THE OPERATOR'S MANAGEMENT. THERE WAS NO PATIENT CONDITION RELATED TO THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO MEDICAL INTERVENTION/TREATMENT DONE TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

Description of Event or Problem

ACCORDING TO THE REPORTER, THERE WAS A GUIDE WIRE DEFECT WITH A FUNCTIONING CENTRAL VENOUS CATHETER (CVC). THIS WAS A CENTRAL VENOUS CATHETER PLACEMENT/IMPLANT FOR DIALYSIS IN THE RIGHT JUGULAR VEIN, A ONE-HOUR PROCEDURE. ONCE THE VENIPUNCTURE WAS PERFORMED, THE GUIDE WIRE WAS INSERTED THROUGH THE NEEDLE, BUT THERE WAS NO MOVEMENT (NO SLIPPAGE), AND THE GUIDE WIRE GOT STUCK. EVERYTHING WAS REMOVED, REVEALING A BROKEN GUIDE WIRE AND FRAY. IT WAS NECESSARY TO REMOVE THE GUIDEWIRE AND THE NEEDLE SIMULTANEOUSLY IN ONE ACTION DUE TO THE ALLEGED DEFECT. THIS WAS THE FIRST TIME THE DEVICE WAS USED. AS A CONSEQUENCE AND REMEDIAL ACTION, THE CATHETER NEEDED TO BE REPLACED WITH ANOTHER MEDICAL DEVICE. THE GUIDEWIRE IN THE KIT WAS THE ONE BEING USED. THE GUIDEWIRE WAS REMOVED BY HAND. THE GUIDEWIRE AND NEEDLE WERE REMOVED. THE GUIDEWIRE WAS SPIRAL, NOT BROKEN, AND THERE WAS NO RESIDUE ON THE PATIENT. THE PROCEDURE WAS COMPLETED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NO PROBLEM. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO CLEANING AGENT WAS USED ON THE DEVICE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT WAS DONE TO THE PATIENT AS A RESULT OF 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.

Description of Event or Problem

ACCORDING TO THE REPORTER, THERE WAS A GUIDE WIRE DEFECT, WITH A FUNCTIONING CENTRAL VENOUS CATHETER (CVC). THIS WAS A CENTRAL VENOUS CATHETER PLACEMENT/IMPLANT FOR DIALYSIS IN THE RIGHT JUGULAR VEIN, A ONE HOUR PROCEDURE. ONCE THE VENIPUNCTURE WAS PERFORMED, THE GUIDE WIRE WAS INSERTED THROUGH THE NEEDLE, BUT THERE WAS NO MOVEMENT (NO SLIPPAGE), AND THE GUIDE WIRE GOT STUCK. EVERYTHING WAS REMOVED, REVEALING A BROKEN GUIDE WIRE. THIS WAS THE FIRST TIME THE DEVICE WAS USED. AS A CONSEQUENCE, THE CATHETER NEEDED TO BE REPLACED WITH OTHER MEDICAL DEVICE. 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.

Description of Event or Problem

ACCORDING TO THE REPORTER, THERE WAS A GUIDE WIRE DEFECT WITH A FUNCTIONING CENTRAL VENOUS CATHETER (CVC). THIS WAS A CENTRAL VENOUS CATHETER PLACEMENT/IMPLANT FOR DIALYSIS IN THE RIGHT JUGULAR VEIN, A ONE-HOUR PROCEDURE. ONCE THE VENIPUNCTURE WAS PERFORMED, THE GUIDE WIRE WAS INSERTED THROUGH THE NEEDLE, BUT THERE WAS NO MOVEMENT (NO SLIPPAGE), AND THE GUIDE WIRE GOT STUCK. EVERYTHING WAS REMOVED, REVEALING A BROKEN GUIDE WIRE AND FRAY. IT WAS NECESSARY TO REMOVE THE GUIDEWIRE AND THE NEEDLE SIMULTANEOUSLY IN ONE ACTION DUE TO THE ALLEGED DEFECT. THIS WAS THE FIRST TIME THE DEVICE WAS USED. AS A CONSEQUENCE AND REMEDIAL ACTION, THE CATHETER NEEDED TO BE REPLACED WITH ANOTHER MEDICAL DEVICE. THE GUIDEWIRE IN THE KIT WAS THE ONE BEING USED. THE GUIDEWIRE WAS REMOVED BY HAND. THE GUIDEWIRE WAS SPIRAL, NOT BROKEN, AND THERE WAS NO RESIDUE ON THE PATIENT. THE PROCEDURE WAS COMPLETED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NO PROBLEM. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO CLEANING AGENT WAS USED ON THE DEVICE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT WAS DONE TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

CORRECTION: B5, G3. 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.