PulseRider Aneurysm Neck Reconstruction Device 303-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859030005109), received between Oct 10, 2018 and Aug 24, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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.

• MalfunctionAug 24, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FILED, A PULSERIDER T ANEURYSM NECK RECONSTRUCTION DEVICE (4MM, 8MM ARCH) WAS USED WITH A PROWLER SELECT PLUS MICROCATHETER (MC) FOR BIFURCATIONS OF THE INTERNAL CAROTID ANEURYSM. AT THE END OF THE PROCEDURE AND IT WAS ATTEMPTED TO BE DETACHED WITH A CABLE (PRDSACE 30393939). THE PROPER INDICATOR FOR DETACHMENT WAS CONFIRMED AND THE COMPLAINT DEVICE WAS RETRACTED SLOWLY BUT THE COMPLAINT DEVICE WAS FALLEN DROP APPROXIMATE 1 OR 2 MM AND IT WAS DETACHED AT THE SAME TIME. THIS COMPLAINT DEVICE SEEMED NOT TO HAVE BEEN DETACHED COMPLETELY. THE PROCEDURE WAS COMPLETED BY MAKING BODY FILLING. THE COIL WAS COVED THE BLOOD VESSEL OF THE BIFURCATION SLIGHTLY BUT THERE WERE NO COMPLICATIONS. THE PULSERIDER WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445782 ↗
• InjuryOct 10, 2018Malposition of Device; Malposition of Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A (B)(6) FEMALE PATIENT PRESENTED WITH AN ANEURYSM FROM THE TOP OF THE BASILAR ARTERY ON NEUROIMAGING STUDIES THAT WAS DONE IN WORK UP AFTER EXPERIENCING A 3-DAY HISTORY OF CONFUSION IN (B)(6) 2018. THE PATIENT UNDERWENT SELECTIVE ANGIOGRAPHY ON (B)(6) 2018, THAT DEMONSTRATED A SMALL, BROAD-BASED ANEURYSM MEASURING 1.8MM X 3.5MM FROM THE TOP OF THE BASILAR ARTERY, PROJECTING SUPERIORLY AND SLIGHTLY TO THE LEFT. THE BASE OF THE ANEURYSM WAS OFFSET TO THE LEFT TO MORE INVOLVE THE COMMON ORIGIN OF THE LEFT POSTERIOR CEREBRAL SUPERIOR CEREBELLAR ARTERIES. A MILD FOCAL NARROWING WAS NOTED AT THE DISTAL BASILAR ARTERY. ELECTIVE TREATMENT WAS RECOMMENDED GIVEN THE SIZE AND LOCATION OF THE ANEURYSM. THE PATIENTLY REPORTEDLY DECLINED NEUROSURGICAL REFERRAL FOR CLIP LIGATION CONSIDERATION; ENDOVASCULAR APPROACH WITH RECONSTRUCTION OF THE ANEURYSM NECK WAS OFFERED USING EITHER THE NEUROFORM STENT OR THE PULSERIDER DEVICES WAS OFFERED. WITH THE LESION LOCATION AT THE DISTAL BASILAR ARTERY, THE PULSERIDER DEVICE WAS CHOSEN. THE PATIENT WAS STARTED ON DUAL ANTIPLATELET THERAPY PRIOR TO THE PULSERIDER PROCEDURE. THE PULSERIDER PROCEDURE TOOK PLACE ON (B)(

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

  MAUDE report 7952298 ↗