PulseRider Aneurysm Neck Reconstruction Device 203-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859030005147), received between Oct 10, 2018 and Apr 18, 2023 — 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.

• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CERENOVUS SALES REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT EMPLOYED THE USE OF A PULSERIDER T SHAPE, 8MM , 3.5MM ¿ 4.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (203D / LOT# UNKNOWN); THE PULSERIDER ANRD WAS IMPLANTED ¿BUT THERE WAS ISSUE.¿ AT THE COMPLAINT INITIATION, THE SALES REPRESENTATIVE REPORTED THAT ¿DETAILS ARE UNKNOWN.¿ ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN SAID, ¿I HAVE BEEN TOLD THAT THERE HAS BEEN A CASE OF THROMBOSIS FOLLOWING THE USE OF PULSERIDER. I HAVE NOT BEEN ABLE TO IDENTIFY THE FACILITY OR THE PATIENT.¿ ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO FURTHER INFORMATION CAN BE OBTAINED. THE PHYSICIAN WHO REPORTED THIS EVENT DOES NOT KNOW AT WHICH FACILITY THE EVENT OCCURRED AT AND THERE IS NO MEANS TO INVESTIGATE FURTHER. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 30-MAR-2023 AND 17-APR-2023, THE EVENT WILL BE CONSERVATIVELY REPORTED TO THE FDA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16764083 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE TREATMENT OF A 4.5MM X 4.0MM WITH A 4.4MM NECK BASILAR TIP ANEURYSM ON A (B)(6) YEAR OLD FEMALE PATIENT WITH A 3-DAY HISTORY OF CONFUSION IN (B)(6) 2018, WHO PRESENTED WITH AN ANEURYSM FROM THE TOP OF THE BASILAR ARTERY. THE PATIENT UNDERWENT SELECTIVE ANGIOGRAPHY ON (B)(6) 2018, WAS STARTED ON DUAL ANTIPLATELET THERAPY PRIOR TO THE PULSERIDER PROCEDURE. ON (B)(6) 2018, AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO POSITION AND DEPLOY THE PULSERIDER Y, 4MM, 8MM ARCH (303D / W2618-07), THE PHYSICIAN DECIDED TO TRY THE PULSERIDER T, 4MM, 8MM ARCH (203D / W3262-02). THE PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED OVER THE WIRE INTO THE BASE OF THE ANEURYSM AND THE PULSERIDER T WAS INTRODUCED THROUGH THE MICROCATHETER. THE DISTAL MARKERS WERE SEEN OPENING AT THE BASE WITHIN THE ANEURYSM. THE LEAVES ON THE DEVICE WERE SEEN FOLLOWING NICELY INTO THE RESPECTIVE POSTERIOR CEREBRAL ARTERIES. THE DEVICE WAS THEN GENTLY ADVANCED TO BRING THE DISTAL MARKERS FLUSH AGAINST THE UPPER WALLS OF THE VESSELS. THE MICROCATHETER WAS WITHDRAWN TO UNSHEATHE AND DEPLOY THE STEM OF THE PULSERIDER T DEVICE, WHICH WAS SEEN OPPOSING THE WALLS OF THE VESSEL VERY

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 7952299 ↗