MAHURKAR

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, DURING CATHETER INSERTION, THE GUIDEWIRE WAS STUCK THROUGH THE PUNCTURE NEEDLE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, THE GUIDEWIRE WAS STUCK THROUGH THE PUNCTURE NEEDLE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS NOT DONE. THE GUIDEWIRE PROVIDED WITH THE KIT WAS THE ONE BEING USED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE GUIDEWIRE WAS UNRAVELED AFTER IT WAS PULLED OUT. THE GUIDEWIRE WAS PULLED OUT AND STILL INTACT WHEN IT WAS REMOVED. THE GUIDEWIRE AND NEEDLE WERE NECESSARY TO REMOVE FROM THE PATIENT SIMULTANEOUSLY (ONE ACTION) DUE TO THE ALLEGED DEFECT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WERE FIVE MILLILITERS OF BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE SAME ID AND LOT ON THE SAME DAY OF THE EVENT. THE PROCEDURE WAS COMPLETED AFTER REMEDIAL ACTION. T HERE WAS NO INTERVENTION/TREATMENT REQUIRED 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, DURING CATHETER INSERTION, THE GUIDEWIRE WAS STUCK THROUGH THE PUNCTURE NEEDLE. THERE WAS NOTHING UNUSUAL TO OBSERVE ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE; THE RESULT WAS NORMAL. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE PROCEDURE WAS COMPLETED AFTER REMEDIAL ACTION. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MOZARC MEDICAL CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED ONE CATHETER AND ONE FRAYED GUIDEWIRE THAT WAS STUCK WITHIN A PUNCTURE NEEDLE. UPON REMOVAL OF THE GUIDEWIRE, FOREIGN MATERIAL WAS NOTED NEAR THE J-HOOK OF THE WIRE. IT WAS REPORTED THAT THE GUIDE WIRE WAS UNABLE TO BE WITHDRAWN. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE ISSUE CAN OCCUR WHEN IDENTITY OF THE MATERIAL WAS A SYNTHETIC POLYMER. 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

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, DURING CATHETER INSERTION, THE GUIDEWIRE WAS STUCK THROUGH THE PUNCTURE NEEDLE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS NOT DONE. THE GUIDEWIRE PROVIDED WITH THE KIT WAS THE ONE BEING USED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE GUIDEWIRE WAS PULLED OUT AND STILL INTACT WHEN IT WAS REMOVED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS 5 MILLILITERS OF BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE SAME ID AND LOT ON THE SAME DAY OF THE EVENT. THE PROCEDURE WAS COMPLETED AFTER REMEDIAL ACTION. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.