CLOSUREFAST 6FR CATHETER

Description of Event or Problem

IT WAS REPORTED THAT THE CLOSUREFAST CATHETER WAS NOT RESPONDING AND WAS NOT RECOGNIZED BY THE RADIOFREQUENCY GENERATOR DURING A PROCEDURE FOR VENOUS INSUFFICIENCY. THE GENERATOR DISPLAYED THE MESSAGE: "THE CONNECTED DEVICE IS UNSUPPORTED. PLEASE CONNECT ANOTHER DEVICE." THERE WAS DAMAGE TO THE CATHETER PLUG, IT WAS JUST NOT RECOGNIZED BY THE RADIOFREQUENCY GENERATOR. THE RED MARK WAS ALIGNED WHEN THE CONNECTOR WAS INSERTED INTO THE GENERATOR. NO BENT PINS, ALL PINS REMAINED ON THE CATHETER CONNECTOR AND THE RFG SOCKET WAS INSPECTED. THE SOFTWARE VERSION ON THE GENERATOR WAS RADIO FREQUENCY GENERATOR 3 VERSION 1.14.2. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE PROBE WAS DAMAGED.

Additional Manufacturer Narrative

PRODUCT ANALYSIS DAMAGE WAS NOTED ALONG THE HEATING COIL/ELEMENT. MICROSCOPIC EXAMINATION REVEALED PEELING/ BUBBLING OF THE FEP LAYER OF THE HEATING ELEMENT/COIL. EXAMINATION ALSO REVEALED THE HEATING ELEMENT/COIL OF THE DEVICE WAS EXPOSED DEVICE DID NOT UNDERGO FUNCTIONAL AND CONTINUITY/RESISTANCE TESTING DUE TO THE DAMAGE SEEN TO THE HEATING ELEMENT/COIL. THE CATHETER CABLE CONNECTOR WAS EXAMINED: THE CATHETER REFERENCE KEY SHOWS EVIDENCE OF WEAR, AND THE RED INK WAS VISIBLE IN SOME AREAS. ALL PINS WERE VISUALLY INSPECTED TO BE STRAIGHT VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THREE KINKS ALONG THE SHAFT, THE KINKS WERE OBSERVED AT APPROX. 33.9 CM, 42.1 CM45.0 CM FROM THE DISTAL TIP OF THE DEVICE 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.