SEISMIQ
Received Jul 2, 2026 · Event occurred Jun 4, 2026
Report 2124215-2026-35630 · MDR key 25699786
Device
Generic name
Percutaneous Catheter, Ultrasound
Manufacturer
Bolt Medical, Inc.Model number
FG-006913Catalog number
FG-006913
Lot number
0000112545
Product problems
- Material Integrity Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: PHYSICIAN NAME WAS NOT PROVIDED TO BOSTON SCIENTIFIC. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE POWER CORD WAS FOUND DISCONNECTED FROM THE WHITE CONNECTOR THAT PLUGS INTO THE CONSOLE, AND SPARKS WERE OBSERVED AT THE SITE OF DISCONNECTION. THE SEISMIQ IVL CATHETER WAS SELECTED FOR USE. AT THE START OF THE PROCEDURE, SPARKS WERE OBSERVED AT THE DISCONNECTION SITE, AND IT WAS FOUND THAT THE POWER CORD WAS DISCONNECTED FROM THE WHITE CONNECTOR THAT PLUGS INTO THE CONSOLE. WHILE THE INTERNAL WIRES OF THE POWER CORD REMAINED INTACT, THE OUTER CASING HAD SEPARATED FROM THE WHITE CONNECTOR/PLUG-IN. A NON- BSC IVL DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO IMPACT ON THE PATIENT WAS REPORTED AND THE PATIENT FULLY RECOVERED.