VIEWFLEX XTRA ICE CATHETER

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND A BROKEN TIP OCCURRED. THE RETURNED DEVICE - ID 0611471 REPROCESSED UNDER LOT 2126248 (1ST TIME REPROCESSING) - WAS RECEIVED COILED INSIDE A RESEALABLE PLASTIC BAG. THE FIRST 2CM OF THE DISTAL TIP (COLORED DARK GREY), HOUSE THE TRANSDUCER AND IS NOT MEANT TO BE FLEXED AND IS RIGID. THIS SECTION WAS OBSERVED TO BE FRACTURED AND BENT, EXPOSING THE INTERNAL STRUCTURE. HOWEVER, THE TIP WAS STILL INTACT AND IN ONE PIECE; IT WAS BROKEN BUT THERE ARE NO UNACCOUNTED FOR OR MISSING PIECES AS IT DID NOT SEPARATE OR DETACH INTO TWO OR MORE PIECES. THERE WERE ALSO TWO OBSERVED KINKS IN THE SHAFT (THE FIRST WAS 7CM FROM THE DISTAL TIP; THE SECOND WAS 10CM FROM THE DISTAL TIP). THE FOUR-WAY DEFLECTION CAPABILITIES OF THE DEVICE OCCUR IN THE NEXT PORTION (9.5CM) OF THE SHAFT (COLORED LIGHT GREY). THE FINDINGS OF THE PHOTO INVESTIGATION WERE VERIFIED. THE OBSERVATION OF THE DAMAGED TIP WAS CONFIRMED. HOWEVER, IT IS NOT DETERMINED IF THE CURRENT APPEARANCE OF THE DEVICE WAS DUE TO ITS HANDLING DURING USE, OR THE MANNER IN WHICH IT WAS RETURNED. REVIEW OF FDA MAUDE ADVERSE EVENT DATABASE REPORTS FROM THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) RELATED SPECIFICALLY TO THE VIEWFLEX D087031 MODEL, THE DISTAL TIP BECOMING FRACTURED "¿IS CONSISTENT WITH DAMAGE DURING USE." THIS DAMAGE IS A NOTED, REPEATED MALFUNCTION.PER FAILURE MODES AND EFFECTS ANALYSIS (FMEA) FOR ST. JUDE VIEWFLEX ICE CATHETER, "CATHETER SHAFT BROKEN BUT NOT DETACHED - DISTAL (INSIDE PATIENT)/(OUTSIDE THE PATIENT)" IS LISTED AS A POTENTIAL HAZARD. THE CAUSE OF SUCH A HAZARD IS "DAMAGE DURING PROCEDURE." THERE IS NO EVIDENCE THAT THE DAMAGE IS A RESULT OF REPROCESSING OR ITS PACKAGING. THE DEVICE HISTORY RECORD FOR LOT 2126248 WAS REVIEWED AND THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING PRIOR TO BEING DISTRIBUTED TO THE FIELD. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED NONCONFORMANCES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND A BROKEN TIP OCCURRED. THE CATHETER WAS REMOVED. THERE WAS NO PATIENT CONSEQUENCE. TWO PHOTOGRAPHS WERE BEEN PROVIDED SHOWING THE DISTAL PORTION OF A CATHETER¿S SHAFT. BOTH PHOTOS SHOW A DAMAGED, BENT DISTAL TIP. ONE PHOTO SHOWS A FRACTURE ACROSS THE SHAFT¿S INSULATION, BUT THERE¿S NO INDICATION OF EXPOSURE OF THE INNER ELEMENTS AND MECHANISMS. WHILE THE SHAFT ALSO APPEARS TO HAVE BENDS AND CURVES FORMED IN, IT CANNOT BE DETERMINED AS TO WHY OR HOW THIS HAS HAPPENED TO THE TIP AND SHAFT. THE CATHETER WAS REMOVED FROM ITS PACKAGING AND HANDLED IN AN UNKNOWN MANNER AND ENVIRONMENT, AND IT WAS PRESENTED AS COILED IN THE PHOTO. THERE WERE NO OTHER IDENTIFYING FEATURES TO VERIFY IF THIS IS EVEN A STERILMED REPROCESSED DEVICE, LET ALONE WHETHER IT IS LINKED TO REPORTED LOT NUMBER 2126248. THERE ARE NO FULL SHOTS OF THE ACCOMPANYING PACKAGE AND LABEL IN ORDER TO EVALUATE THE CONDITION OF THE PACKAGING MATERIALS. BASED SOLELY ON THE AREA OF THE DEVICE THAT IS CAPTURED BY THE PHOTO, THE REPORTED ISSUE OF A BROKEN TIP IS CONFIRMED. AS THE EVENT WAS NOTED TO HAVE OCCURRED INTRA-OP, AND THE APPEARANCE IS INDICATIVE OF DAMAGE DURING USE, THE PHOTOGRAPH IS INSUFFICIENT TO ESTABLISH A CAUSE FOR THE OBSERVED DAMAGE AND NOTHING IN IT CAN BE ATTRIBUTED TO A FAILURE IN THE PACKAGING. WHILE THE CATHETER FROM THE PHOTO CANNOT BE VERIFIED AS COMING FROM THIS LOT 2126248, A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THE DEVICES REPROCESSED UNDER IT PASSED ALL FINISHED GOODS VISUAL CRITERIA PRIOR TO BEING SHIPPED TO THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED NONCONFORMANCES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. HOWEVER, A PHOTO WAS OBTAINED OF THE DEVICE WHICH IS UNDER REVIEW. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND A BROKEN TIP OCCURRED. THE CATHETER WAS REMOVED. THERE WAS NO PATIENT CONSEQUENCE.