ELCA™ 110-004AARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132020033), received between Oct 17, 2018 and Dec 14, 2022 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE PATIENT'S LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. MULTIPLE GUIDE WIRES, CATHETERS, AND A SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER WERE USED TO TREAT THE PATIENT. AFTER THE ELCA MADE 2 PASSES AT 60/60 FLUENCY/RATE AND 5 PASSES AT 80/80 FLUENCY/RATE, IT WAS REMOVED FROM THE PATIENT. DURING THE PROCEDURE, AN LAD PERFORATION WAS DISCOVERED; THE PHYSICIAN STATED THE ELCA CAUSED THE PERFORATION. BALLOONS WERE USED WITHIN THE LAD, AND A COVERED STENT WAS DEPLOYED TO EFFECTIVELY COVER THE PERFORATION. THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE ELCA IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE ELCA DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 15981061 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CORONARY LASER ATHERECTOMY PROCEDURE FOR A CHRONIC TOTAL OCCLUSION OF THE CIRCUMFLEX ARTERY, THE PHYSICIAN WAS UNABLE TO ADVANCE THROUGH THE LESION (BALLOONS, ETC., WOULD NOT WORK). THE PHYSICIAN BEGAN LASING WITH THE ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004. AN ARTERY WAS PERFORATED. THE PHYSICIAN ATTEMPTED TO STOP THE BLEEDING WITH A BALLOON, BUT COULD NOT. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR REPAIR OF THE INJURY. PHYSICIAN WAS UNSURE WHAT CAUSED THE ARTERY PERFORATION. THE PATIENT'S STATUS HAS BEEN REQUESTED FROM THE SITE, BUT NO INFORMATION HAS BEEN PROVIDED OTHER THAN WHAT IS CONTAINED HEREIN.

  Patient problems: Death; Iatrogenic Source; Perforation of Vessels

  MAUDE report 7976271 ↗