NANOCROSS 0.14 OTW PTA DILATATION CATHETER

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE NANOCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON, THE BALLOON BURST. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO INJURY, INTERVENTION, OR HEALTH CONSEQUENCES WERE REPORTED FOR THE PATIENT.

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.