CATHERA

Additional Manufacturer Narrative

RECEIVED FROM MEDWATCH: MW5104101. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

2021-OCT-04 MW5104101 (OTH): MEDTRONIC RECEIVED INFORMATION THAT A PHENOM CATHETER TIP HAD SHEARED OFF AND A SECOND MARKER TIP WAS NOTICED ON A QAPEL WAHOO CATHETER. IT WAS REPORTED THAT SUBOPTIMAL APPOSITION OF THE STENT AT THE DISTAL END AND INTRODUCED A TRANSFORM 7X7MM BALLOON ALONG WITH THE TRAXCESS MICROWIRE. DURING THE INTRODUCTION OF THE MICROCATHETER, IT WAS NOTICED THERE WAS A SECOND RADIO-OPAQUE MARKER AT THE TIP OF THE WAHOO JUST AS THE MICROWIRE WAS ABOUT TO REACH THE END OF THE WAHOO TIP. HOWEVER, BY THEN, IT WAS TOO LATE AS THE MICROWIRE GENTLY TOUCHED THE RADIO-OPAQUE MARKER AND IT TRAVELLED DISTALLY INTO THE LEFT DISTAL PCA. IT WAS AT THIS TIME THAT THE PHENOM PLUS CATHETER WAS CHECKED AND NOTED THAT THE TIP WAS SHEARED OFF. HOWEVER, GIVEN THE DISTAL LOCATION OF THE CURRENT MARKER TIP LOCATION, AND IT DOES NOT APPEAR TO BE OCCLUSIVE. REPEAT ANGIOGRAM DID NOT SHOW THROMBOSIS. WE FELT THAT IT WOULD BE SAFER TO LEAVE IT AS IT IS