SLS II Laser Sheath 500-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132020293), received between Sep 12, 2018 and Aug 31, 2020 — 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 18, 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.

• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A LEFT VENTRICULAR (LV) LEAD DUE TO NON FUNCTION. A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD WERE PRESENT IN THE PATIENT, BUT WERE NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LV LEAD TO ACT AS A TRACTION PLATFORM TO AID IN EXTRACTION. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS 12F SLSII LASER SHEATH. THE PHYSICIAN REPORTEDLY LASED IN THE CORONARY SINUS, NEAR THE OSTIUM. THE LV LEAD WAS SUCCESSFULLY REMOVED. HOWEVER, THE PHYSICIAN NOTED HEMODYNAMIC CHANGES IN THE PATIENT, TEN MINUTES AFTER THE EXTRACTION WAS COMPLETED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. A 2 CM INJURY WAS DISCOVERED, 1-2CM INTO THE CORONARY SINUS FROM THE OSTIUM. BASED ON THE INJURY LOCATION AND SHAPE, THE PHYSICIAN BELIEVES IT WAS A COMBINATION OF THE SCAR TISSUE TEARING AWAY FROM THE PROXIMAL CORONARY SINUS ALONG WITH LASER USE. THE REPAIR TO THE AREA WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT IS BEING SUBMITTED SINCE THE SLSII DEVICE WAS REPORTEDLY LASING IN THE AREA OF INJURY. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICE IN US

  Patient problems: Iatrogenic Source; Perforation of Vessels

  MAUDE report 10473298 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS DOCUMENTED AS PART OF A LITERATURE REVIEW COMPLETED BY CLINICAL DEPARTMENT AT SPECTRANETICS (SPNC). SPNC WAS MADE AWARE OF THIS INFORMATION ON (B)(6) 2018. THE FEBRUARY 2018 ARTICLE FROM THE EUROPEAN SOCIETY OF CARDIOLOGY ENTITLED, "NEW ONSET OF PHRENIC NERVE PALSY AFTER LASER-ASSISTED TRANSVENOUS LEAD EXTRACTION: A SINGLE-CENTRE EXPERIENCE", DOCUMENTED A NEW ONSET OF PHRENIC NERVE PALSY (PNP) AFTER LASER-ASSISTED TRANSVENOUS LEAD EXTRACTION IN FIVE PATIENTS, CONFIRMED BY A NEWLY ELEVATED HEMIDIAPHRAGM AFTER EXTRACTION; ALL THE PATIENTS WHO EXHIBITED PNP WERE REFERRED FOR LEAD EXTRACTION BETWEEN JANUARY 2009 AND SEPTEMBER 2012, WITH ACTUAL PROCEDURE DATE UNKNOWN, SO IS POPULATED AS 1ST OF JANUARY, 2009. PATIENT HAD A RIGHT VENTRICULAR (RV) LEAD EXTRACTED USING AN SLS DEVICE. AFTER A BROAD DIAGNOSTIC WORKUP, INCLUDING ECHOCARDIOGRAPHY AND REPEATED REPROGRAMMING OF THE DEVICE, A CHEST X-RAY REVEALED AN IPSILATERAL ELEVATION OF THE HEMIDIAPHRAGM ALLOWING THE DIAGNOSIS OF PNP. PATIENT HAD EXPERIENCED ATYPICAL CHEST PAIN, DIAGNOSED WITH PNP AFTER TWO WEEKS. SYMPTOMS IMPROVED GRADUALLY AND DISAPPEARED WITHIN 3-6 MONTHS WITHOUT NECESSITY OF ANY TREATMENT.

  Patient problems: Iatrogenic Source; Nerve Damage

  MAUDE report 7870049 ↗