ELCA Coronary Laser Atherectomy Catheter 110-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00813132025458), received between Oct 15, 2018 and Apr 29, 2026 — classified as 2 deaths, 6 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT WITH A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER. DURING USE, THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM DISPLAYED AN ERROR CODE WHEN INCREASING THE FLUENCY, AND THE CATHETER COULD NOT BE UTILIZED. AFTER RECALIBRATION AND RESTARTING THE LASER SYSTEM, THE SAME ISSUE OCCURRED. WHEN LOWERING THE PULSE AND FLUENCY, THE ELCA DEVICE PERFORMED WITHOUT FURTHER ISSUE, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 08APR2026, VISUAL INSPECTION FOUND BROKEN FIBERS AND MISSING EPOXY AT THE ELCA DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH MISSING MATERIAL; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029741 ↗
• MalfunctionMar 19, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT USING A SPECTRANETICS ECLA LASER ATHERECTOMY CATHETER. DURING A THIRD PASS ATTEMPT, THE FOOT PEDAL OF THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM WAS PRESSED; HOWEVER, THE ELCA WAS NOT WORKING. THE LASER SYSTEM WAS RESTARTED, THE ELCA WAS RE-CALIBRATED, BUT THE SAME ISSUE OCCURRED. THE ELCA WAS REMOVED, AND NEW ELCA WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. DURING EVALUATION ON 19FEB2026, VISUAL INSPECTION FOUND A BREACH TO THE WORKING LENGTH, WITH BROKEN FIBERS. MELTING OF THE OUTER JACKET WAS OBSERVED 4 MM FROM THE DISTAL TIP. CALIBRATION WAS NO POSSIBLE DUE TO THE BREACH AT THE WORKING LENGTH. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24645888 ↗
• MalfunctionMar 19, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A SPECTRANETICS ECLA LASER ATHERECTOMY CATHETER WAS BEING CALIBRATED; HOWEVER, CALIBRATION WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE ELCA, WITH NO REPORTED PATIENT HARM. DURING EVALUATION ON 19FEB2026, VISUAL INSPECTION FOUND A BREACH/PUNCTURE TO THE WORKING LENGTH, WITH A BROKEN FIBER VISIBLE. MELTING OF THE OUTER JACKET WAS OBSERVED 86 MM FROM THE DISTAL TIP. CALIBRATION WAS NOT POSSIBLE DUE TO THE BREACH AT THE WORKING LENGTH. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24645863 ↗
• MalfunctionMar 12, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER, ALONG WITH A 0.014 GUIDEWIRE (MANUFACTURER UNKNOWN), TERUMO 6F INTRODUCER SHEATH, AND A CORDIS 6F GUIDE CATHETER, WERE USED TO TREAT THE PATIENT. DURING USE, LASER LIGHT WAS OBSERVED EMITTING NEAR THE PLUG. THE ELCA WAS REMOVED AND A NEW ELCA WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 24586029 ↗
• MalfunctionMar 6, 2026Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION. A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM DISPLAYED AN ERROR CODE, AND THE CATHETER COULD NOT BE UTILIZED. OTHER METHODS WERE USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 12FEB2026: VISUAL INSPECTION FOUND A SMALL BUMP, DEAD FIBERS, AND MISSING EPOXY AT THE ELCA DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH MISSING MATERIAL; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532741 ↗
• MalfunctionFeb 19, 2026Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE MID CIRCUMFLEX ARTERY. DURING USE OF A SPECTRANETICS ECLA LASER ATHERECTOMY CATHETER, WHEN REMOVING THE CATHETER FROM THE BODY, A ZIPPER TEAR WAS OBSERVED AT THE DISTAL END OF THE OUTER JACKET. THE CATHETER WAS REMOVED AND A BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24393144 ↗
• MalfunctionNov 18, 2025Entrapment of Device; Entrapment of Device

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER, ALONG WITH A NON-PHILIPS GUIDEWIRE AND GUIDE CATHETER WERE BEING USED TO TREAT THE PATIENT. DURING PULLBACK, IT WAS NOTED THAT THE ELCA WAS STUCK IN THE GUIDE CATHETER. THEREFORE, THE PHYSICIAN CUT THE ELCA AND GUIDEWIRE, AND REMOVED EVERYTHING TOGETHER, INCLUDING THE GUIDE CATHETER, KEEPING THE DISTAL PORTION OF THE GUIDEWIRE IN PLACE. TREATMENT WAS COMPLETED USING A BALLOON, WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO ENTRAPMENT, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583296 ↗
• MalfunctionNov 12, 2025Entrapment of Device; Entrapment of Device

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED USING A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING ADVANCEMENT TO THE LESION, THE CATHETER BECAME STUCK ON A NON-PHILIPS GUIDEWIRE; THEREFORE, REMOVED AS A SYSTEM. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537737 ↗
• MalfunctionJul 28, 2025Activation, Positioning or Separation Problem

  FROM STAFF: SUCCESSFUL TAVR [TRANSCATHETER AORTIC VALVE REPLACEMENT] PROCEDURE, COMPLICATED BY VALVE EMBOLIZATION REQUIRING CONVERSION TO SURGICAL AVR [AORTIC VALVE REPLACEMENT] WITH PLACEMENT OF A NUMBER 23 EDWARDS SAPIEN INSPIRIS VALVE. FROM OPERATIVE REPORT: ESSENTIALLY THE VALVE DID NOT DEPLOY CORRECTLY INTO THE AORTIC ANNULUS AND SUBSEQUENTLY EMBOLIZED INTO THE LEFT VENTRICLE. WE IMMEDIATELY RECOGNIZED THIS AND CALLED FOR BACKUP SURGICAL ASSISTANCE, PERFUSION, AND ALL PREPARATION FOR STERNOTOMY CUT DOWN AND BAILOUT. PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THIS TIME. WE ELECTED TO LEAVE THE SHEATH AND TAVR DEVICE IN THE CAROTID ARTERY WHICH WAS COVERED TO PREVENT DISLODGEMENT. WE MADE A STERNOTOMY INCISION AND THEN PROCEEDED TO OPEN THE PERICARDIUM. THE PATIENT'S ACT [ACTIVATED CLOTTING TIME] WAS NOTED TO BE OVER 400 SECONDS FROM PREVIOUSLY ADMINISTERED HEPARIN. GIVEN THE RELATIVE HEMODYNAMIC STABILITY WITH LOW PRESSOR REQUIREMENT, WE ELECTED TO PROCEED WITH CENTRAL CANNULATION RATHER THAN FEMORAL CANNULATION FOR CARDIOPULMONARY BYPASS. CONCENTRIC PURSE STRINGS WERE PLACED IN THE AORTA (AT AN AREA FREE OF CALCIFICATION AND PLAQUE) AND THE RIGHT ATRIUM AND CANNULAE WERE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622868 ↗
• MalfunctionJun 24, 2025Off-Label Use; Material Separation; Off-Label Use; Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT VIA RADIAL ACCESS (OFF-LABEL USE). DURING USE, THE CATHETER COULD NOT BE RECOGNIZED AFTER INSERTION AND FAILED TO CALIBRATE. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 29MAY2025, VISUAL INSPECTION FOUND THE INNER LUMEN WAS DEFORMED INWARD, AND THERE WAS MISSING AND BROKEN EPOXY, WITH CHIPPED FIBERS AT THE ELCA DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH MISSING MATERIAL, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318195 ↗
• MalfunctionApr 29, 2025Entrapment of Device; Entrapment of Device

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER WAS PLACED OVER A TERUMO 0.014 RUNTHROUGH GUIDEWIRE, AND INSERTED THROUGH A CORDIS 6F GUIDE CATHETER. DURING ADVANCEMENT, RESISTANCE WAS ENCOUNTERED INSIDE OF AN EXISTING STENT; HOWEVER, THE ELCA PROGRESSED UNTIL IT REACHED THE LAD LOCATED WITHIN ANOTHER STENT DISTALLY, AND ACTIVATED. RESISTANCE WAS ENCOUNTERED AGAIN; THEREFORE, FLUENCY AND RATE OF THE LASER CATHETER WAS INCREASED, WITHOUT SUCCESS. THE DECISION WAS THEN MADE TO ABANDON THE PROCEDURE, AND WHEN ATTEMPTING TO REMOVE THE ELCA, IT WOULD NOT RETREAT BACK INTO THE GUIDE CATHETER, EVEN AFTER SOME TROUBLE SHOOTING. THE ENTIRE SYSTEM WAS REMOVED FROM THE BODY, WHEN THE PATIENT EXPERIENCED ARM PAIN; AND WAS ADMINISTERED STANDARD MEDICATION TO RELIEVE THE PAIN. (PER PHILIPS CLINICAL ASSESSMENT, THE ARM PAIN IS NOT RELATED TO THE ELCA OR THE GUIDE WIRE, AND WAS LIKELY RELATED TO ARTERIAL SPASM AROUND THE GUIDE CATHETER.) OUTSIDE OF THE PATIENT, A PIECE OF PLASTIC WAS OBSERVED EXTENDING OUT FROM THE GUIDEWIRE EXIT PORT, ALONG WITH A DAMAGED GUIDEWIRE THAT WAS REMOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931154 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. MULTIPLE DEVICES (SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER, PHILIPS OMNIWIRE PRESSURE GUIDE WIRE, PHILIPS EAGLE EYE PLATINUM IVUS CATHETER, PHILIPS ANGIOSCULPT SCORING BALLOON CATHETER, TERUMO 0.014 RUNTHROUGH GUIDEWIRE, TERUMO 6F INTRODUCER SHEATH, AND MEDTRONIC 6F GUIDE CATHETER) WERE USED TO TREAT THE PATIENT. DURING USE OF THE ELCA CATHETER, A PERFORATION WAS NOTED IN THE LAD. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING AN ABBOTT GRAFTMASTER CORONARY STENT GRAFT SYSTEM, A BALLOON TO SEAL THE PERFORATION, AND SURGICAL TREATMENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE ELCA IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 21861246 ↗
• InjuryMar 11, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THIS ADVERSE EVENT IS NO LONGER REPORTABLE BECAUSE THE PERFORATION WAS NOT DUE TO THE ELCA DEVICE; RATHER IT WAS A WIRE FROM A DIFFERENT MANUFACTURER.

  Patient problems: Perforation of Vessels

  MAUDE report 21576971 ↗
• MalfunctionJan 29, 2025Sharp Edges; Sharp Edges

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE IN THE RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE CATHETER GAVE AN ERROR TWO TO THREE SECONDS AFTER LASER EXPOSURE. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. UPON COMPLETION OF THE ELCA DEVICE EVALUATION ON 10JAN2025, VISUAL INSPECTION FOUND SHARP EDGES AT THE DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH SHARP EDGES AT THE DISTAL TIP, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269037 ↗
• MalfunctionOct 22, 2024Material Separation; Sharp Edges; Material Separation; Sharp Edges

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL CIRCUMFLEX ARTERY. A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING THE PROCEDURE, THE DISTAL TIP OF THE CATHETER APPEARED DAMAGED, AND USE OF THE DEVICE WAS DISCONTINUED. ANOTHER 0.9MM CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION 17OCT2024, MISSING MATERIAL AND SHARP EDGES WERE DISCOVERED AT THE ELCA DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH MISSING MATERIAL AND SHARP EDGES AT THE DISTAL TIP, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511149 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT MODERATELY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER THE ATHERECTOMY WAS COMPLETED, THE ELCA GOT CAUGHT ON THE 7F GUIDE CATHETER, AND BOTH THE GUIDE CATHETER AND ELCA WERE REMOVED AS A SYSTEM. UPON REMOVAL, IT WAS OBSERVED THAT THE ELCA EXIT WIRE PORT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. UPON COMPLETION OF THE ELCA DEVICE EVALUATION AND INVESTIGATION ON 19SEP2024, A BREACH IN THE OUTER JACKET WAS DETECTED, WITH VISIBLE FIBERS PRESENT IN THE AREA OF THE BREACH. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20322266 ↗
• MalfunctionAug 21, 2024Material Separation; Sharp Edges; Material Separation; Sharp Edges

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION (WITHIN AN EXISTING STENT) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS BEING USED TO TREAT THE PATIENT. DIFFICULTY WAS ENCOUNTERED WHILE PASSING THROUGH THE LESION, AND AFTER LASING NEAR THE STENT, ANGIOGRAPHY DETECTED THAT THE STENT WAS SLIGHTLY DEFORMED. UPON REMOVAL OF THE ELCA, IT WAS NOTED THAT THE OUTER JACKET WAS PEELING AT THE DISTAL TIP, ALONG WITH A BURNING SMELL. A BALLOON WAS USED TO COMPLETE THE PROCEDURE, WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 20017979 ↗
• MalfunctionSep 12, 2023Material Separation; Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER LASING 8 TIMES SUCCESSFULLY, AN ATTEMPT WAS MADE TO LASE FOR THE 9TH TIME, WHEN THE SURGEON HAD A FEELING OF ELECTRICAL LEAKAGE. AN ABRASION IN THE EPIDERMAL LAYER OF THE CATHETER WAS NOTED, AND USE OF THE DEVICE WAS DISCONTINUED. SOME OF THE CONTRAST MEDIA IN THE CORONARY ARTERIES REMAINED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17733285 ↗
• InjuryJun 21, 2023Failure to Calibrate; Failure to Calibrate

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT HAD BEEN PREPPED WITH GROIN ACCESS, ANGIOGRAMS HAD BEEN TAKEN, AND GIVEN MODERATE SEDATION. A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER COULD NOT BE CALIBRATED. TWO DIFFERENT LASER SYSTEMS WERE USED TO ATTEMPT CALIBRATION WITH NO SUCCESS; CALIBRATION OF A NEW ELCA WAS THEN ATTEMPTED, BUT FAILED AS WELL. THE PROCEDURE WAS ABORTED SINCE NO OTHER TREATMENT WAS AVAILABLE. THE GROIN ACCESS REQUIRED CLOSURE AND THE PATIENT SURVIVED, WITH PLANS TO RESCHEDULE THE PROCEDURE AT A LATER DATE. THIS REPORT CAPTURES THE SECOND ELCA WHICH WOULD NOT CALIBRATE AFTER THE PROCEDURE HAD BEGUN, REQUIRING INTERVENTION (GROIN CLOSURE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172761 ↗
• InjuryMay 18, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) OF THE PATIENT''S RIGHT CORONARY ARTERY (RCA). AN ELCA CORONARY ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER SEVERAL ATTEMPTS AT CLEARING THE LESION, THE ELCA WAS REMOVED FROM THE BODY. THE TIP OF THE CATHETER WAS DISCOVERED TO BE DAMAGED, AND RADIOGRAPHY SHOWED THERE SEEMED TO BE FOREIGN BODIES REMAINING IN THE CROWN OF THE LESION. IT COULD NOT BE CONFIRMED IF THE FOREIGN BODIES WERE COMPONENTS OF THE ELCA. ADDITIONAL METHODS TO ATTEMPT DILATION WERE NOT SUFFICIENT TO OPEN THE LESION. THE ORIGINAL CTO WAS NOT CLEARED, THE PATIENT''S VITAL SIGNS REMAINED STABLE, AND NO FURTHER FOLLOW UP WAS PERFORMED. THE PATIENT SURVIVED. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION, TO CAPTURE THE ELCA WITH SUSPECTED MARKER BAND SEPARATION, POSSIBLY RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956254 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE PATIENT'S PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER WAS SELECTED TO TREAT THE PATIENT. THE ELCA CALIBRATED SUCCESSFULLY, BUT DURING USE IN THE PATIENT AN "ERROR 3" CODE WAS DISPLAYED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER AND THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED PATIENT HARM. DURING THE PRODUCT RETURN EVALUATION, A BREACH IN THE OUTER JACKET WAS DISCOVERED. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16765639 ↗
• MalfunctionApr 25, 2022Break; Break

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE PATIENT'S MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PHYSICIAN USED A SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, THE DEVICE WAS REMOVED AND IT WAS OBSERVED THAT AN INTERNAL PIECE OF THE DEVICE WAS STICKING OUT OF THE PROXIMAL PORTION OF THE RAPID EXCHANGE PORT WHERE THE GUIDE WIRE IS INSERTED. A NEW ELCA DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14197298 ↗
• MalfunctionMar 8, 2022Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION A DISTAL SAPHENOUS VEIN GRAFT (SVG) TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER TO TREAT THE PATIENT. WHEN THE ELCA CATHETER WAS TURNED ON INSIDE THE PATIENT, THE DEVICE WOULD NOT WORK. THE PHYSICIAN REMOVED THE CATHETER AND NOTICED THE DISTAL PART OF THE CATHETER HAD A HOLE IN IT, WITH A THREAD OF SOMETHING STUCK OUT OF THE HOLE. IN THE PHOTOS PROVIDED TO THE MANUFACTURER, MATERIAL DEFORMATION WAS APPARENT IN A PORTION OF THE DEVICE''S WORKING LENGTH. THE PHYSICIAN ABORTED THE PROCEDURE WITH NO REPORTED PATIENT HARM. BASED ON THE EVENT DESCRIPTION AND PHOTOS PROVIDED, THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13690737 ↗
• InjuryMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERCUTANEOUS CORONARY INTERVENTION (PCI) COMMENCED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) OF THE PATIENT'S MID RIGHT CORONARY ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS 9F ELCA CORONARY ATHERECTOMY CATHETER. THE PHYSICIAN PERFORMED FOUR PASSES THROUGH THE LESION, ALL WITH A CONTINUOUS FORWARD MOTION. THE ELCA DEVICE SAT, LASING AT THE CAP OF THE LESION FOR APPROXIMATELY THREE SECONDS FOR EITHER THREE OR FOUR OF THE PASSES. AFTER TREATMENT, THE ELCA DEVICE WAS REMOVED WITH EASE. APPROXIMATELY FIFTEEN MINUTES LATER, THE SCRUB TECH NOTICED THAT THE RADIOPAQUE MARKER BAND WAS NOT SEEN AT THE DEVICE'S DISTAL TIP. FLUOROSCOPIC IMAGES WERE TAKEN, AND THE PHYSICIAN STATED HE WAS SURE THE MARKER BAND WAS OUT OF THE BODY. THE POLYMER COATED WIRE THAT WAS USED CONCOMITANTLY WITH THE ELCA DEVICE WAS REMOVED FROM THE PATIENT AS WELL. THE PHYSICIAN USED ANOTHER GUIDE WIRE TO RE-CROSS THE LESION, AND THE PROCEDURE WAS COMPLETED USING A ROTABLATOR, A BALLOON AND A STENT WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE ELCA DEVICE IN USE WHEN THE DEVICE'S MARKER BAND DETACHED, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638866 ↗
• MalfunctionAug 7, 2020Break; Break

  A CORONARY VASCULAR INTERVENTION PROCEDURE WAS BEING PERFORMED, WITH THE PHYSICIAN USING A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. IT WAS INITIALLY REPORTED TO THE MANUFACTURER ON 12 JUNE 2020 THAT WHILE PREPPING THE DEVICE ON THE SURGICAL TABLE, THE GUIDE WIRE CAME OUT OF THE DEVICE FROM AN OPENING OTHER THAN THE GUIDE WIRE PORT. IT WAS REPORTED THE CATHETER WAS TORN 2 INCHES FROM THE DEVICE''S DISTAL TIP. FOLLOW UP QUESTIONS WERE ASKED OF THE PHILIPS REPRESENTATIVE ON (B)(6) 2020; PER REPORT, THE FACILITY SAW NO EXPOSED OR VISIBLE FIBERS FROM THE REPORTED HOLE, NOR DID THEY SEE LIGHT COMING FROM THE HOLE. IT WAS REPORTED THAT THEY WEREN'T AWARE OF THE DEVICE ENTERING THE PATIENT''S BODY, AND THEY ALSO REPORTED OBSERVING A HOLE IN THE DEVICE''S PACKAGING WHEN THE GUIDE WIRE WAS THREADED INTO THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND ELCA DEVICE WITH NO REPORTED PATIENT HARM. HOWEVER, WHEN THE ELCA DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATED ON (B)(6) 2020, A BREACH IN THE DEVICE''S CONSTRUCTION WAS IDENTIFIED. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10378952 ↗