NYKANEN RADIOFREQUENCY WIRE KIT (CABLE)

Description of Event or Problem

ON (B)(6) 2026, THE SITE REPORTED CONNECTION FAILURES BETWEEN THE GENERATOR AND TWO SEPARATE CONNECTOR CABLES DURING A PEDIATRIC CASE (MALE, 12 YEARS OLD). WHEN CONNECTING THE FIRST CABLE ASSOCIATED WITH THE NYKANEN RF WIRE KIT (REF RFK-265, LOT RKFA260825) TO THE GENERATOR, THE SYSTEM DISPLAYED AN ERROR (REPORTED AS "AO29"). THE TEAM THEN OPENED A VERSACROSS KIT (REF VXSK0031, LOT 34727339); UPON CONNECTING THAT CABLE, THE SAME ERROR OCCURRED. THE SITE BORROWED A GENERATOR FROM AN ADULT FACILITY AND AGAIN OBSERVED THE SAME ERROR WITH BOTH INITIALLY OPENED CABLES. PER BOSTON SCIENTIFIC SUPPORT'S SUGGESTION TO TRY ANOTHER CABLE, THE TEAM OPENED A THIRD VERSACROSS KIT, AND THAT CABLE CONNECTED SUCCESSFULLY TO THE SITE'S GENERATOR, ALLOWING THE CASE TO PROCEED. PER (B)(6) FOLLOW-UP, THE PATIENT WAS PREPPED AND, ON THE TABLE, AND VASCULAR ACCESS WAS OBTAINED PRIOR TO THE CONNECTION ATTEMPTS. THE EVENT CAUSED A 30-45 MINUTE DELAY. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. WHILE THERE WAS NO ADVERSE EVENT RELATED TO THE USE OF THE BAYLIS MEDICAL TECHNOLOGIES (BMT) DEVICE, BMT CONSIDERS A DEVICE MALFUNCTION LEADING TO A SURGICAL DELAY OF GREATER THAN 15 MINUTES TO BE AN FDA REPORTABLE EVENT. AS A RESULT, THIS REPORT IS BEING SUBMITTED TO THE FDA FOR THE CABLE INCLUDED IN NYKANEN RF WIRE KIT (REF RFK-265, LOT RKFA260825).

Additional Manufacturer Narrative

THIS COMPLAINT IS IN REGARD TO THE RFP-100A CONNECTOR CABLE PACKAGED AS A KIT WITH THE NYKANEN RF WIRE. DEVICE IS IN TRANSIT FOR RETURN, HAS YET TO BE RECEIVED.