PulseRider Aneurysm Neck Reconstruction Device 301-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00859030005116), received between Dec 27, 2017 and Jun 27, 2019 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Unintended Movement; Unintended Movement

  THE EVENT WAS REPORTED THROUGH THE (B)(6) STUDY THAT THE (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPERTENSION, HYPERLIPIDAEMIA, PERIPHERAL ARTERY DISEASE, PERIPHERAL VASCULAR DISEASE (TWO STENTING SURGERIES FOR PVD), HEADACHES, SMOKING, LEFT LEG NUMBNESS, GUILLAIN-BARRÉ SYNDROME, AND RENAL INSUFFICIENCY PRESENTED WITH A MIDLINE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH THE FOLLOWING CHARACTERISTICS AND DIMENSIONS: 2.3MM PARENT VESSEL DIAMETER, MAXIMUM ANEURYSM DIAMETER WAS 8.9MM, 5.7MM DOME, 4.3MM NECK SIZE, AND A DOME TO NECK RATIO OF 1.3MM UNDERWENT THE STENT-ASSISTED EMBOLIZATION INDEX PROCEDURE ON (B)(6) 2019. ONE OF THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICES (ANRD) THAT WAS CHOSEN WAS THE PULSERIDER Y, 3MM, 8MM ARCH (301D / W3274-13). THE PULSERIDER DEVICE WAS DEPLOYED AT THE TARGET SITE AND PRIOR TO DETACHMENT, THE DEVICE MOVED AWAY FROM ITS INTENDED POSITION OF PLACEMENT. DUE TO THE TORTUOSITY OF THE PATIENT¿S VASCULATURE, THE PULSERIDER DEVICE WAS NOT IMPLANTED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742185 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PATIENT DEVELOPED DIPLOPIA TWO HOURS FOLLOWING A PULSERIDER-ASSISTED (301D/W3121-02) COIL EMBOLIZATION OF A 9.3 X 6.3 X 6.8MM INCIDENTAL BASILAR TIP ARTERY ANEURYSM (8.6-MM ARCH WIDTH, 2.7 - 3.5MM PARENT VESSEL DIAMETER). EYE EXAM REVEALED RIGHT INTERNUCLEAR OPHTHALMOPLEGIA. DESPITE TREATMENT, THE DOUBLE VISION RETURNED AND WAS AGAIN TREATED. MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 1-MM HEMORRHAGE IN THE RIGHT PARAMEDIAN MIDBRAIN, THE LOCATION OF THE MEDIAL LONGITUDINAL FASCICULUS. IT WAS FURTHER STATED THAT THE SWELLING THAT RESULTED FROM THE HEMORRHAGE MAY HAVE CAUSED THE DOUBLE VISION. THE DIPLOPIA RESOLVED WITHIN 24 HOURS WITH DEXAMETHASONE. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY TWO. THE INDEX PROCEDURE WAS UNEVENTFUL AND CONSIDERED SUCCESSFUL. THERE WERE NO KNOWN INTRAPROCEDURAL ADVERSE EVENTS OR PRODUCT MALFUNCTIONS/DIFFICULTIES. MEDTRONIC AXIUM 3D, MEDTRONIC PRIME, AND MEDTRONIC HELICAL COILS WERE PLACED DURING THE CASE. THERE WAS NO EVIDENCE OF COIL PROTRUSION INTO THE PARENT VESSEL. THE DURATION OF THE PROCEDURE WAS APPROXIMATELY 75 MINUTES. THE PHYSICIAN WAS REPORTEDLY SATISFIED WITH THE RESULTS OF THE CASE. OF NOT

  Patient problems: Infarction, Cerebral; Intracranial Hemorrhage

  MAUDE report 7579336 ↗
• InjuryFeb 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, POST PROCEDURE OF A COIL EMBOLIZATION WITH A PULSERIDER (301D, W3090-16), THE PATIENT DISPLAYED ATYPICAL BEHAVIOR WHEN COMING OUT OF ANESTHESIA. UPON SUBSEQUENT EVALUATION UNDER FLURO IT WAS DETERMINED THE PATIENT¿S ANTERIOR CEREBRAL VESSEL (A1) WAS BLOCKED. THE PATIENT WAS TAKE BACK TO THE TABLE AND AFTER SEVERAL RUNS UNDER FLURO THE VESSEL OPENED. THE PATIENT¿S SYMPTOMS RESOLVED WITH NO RESIDUAL AND IS NOW FULLY FUNCTIONAL AND BACK TO WORK. THIS WAS A COIL EMBOLIZATION TO AN INTRA-ANEURYSM TO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE ANEURYSM WAS 6.6 MM IN HEIGHT, 5.6 MM IN WIDTH AND 5.8 MM IN DEPTH. THE NECK SIZE WAS 6.8 MM AND THE TARGET VESSEL SIZE WAS 2.8. THE VESSEL WAS MILDLY TORTUOUS. THE PULSERIDER WAS SUCCESSFULLY PLACED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A 5 MM PROWLER SELECT PLUS MICROCATHETER. IN ADDITION TO THE PULSERIDER DEVICE, 6 ORBIT COILS WERE USED TO SUCCESSFULLY PLACED TO EMBOLIZE THE ANEURYSM. THE PROCEDURE WAS DEEMED SUCCESSFUL BY THE PHYSICIAN AS THE ANEURYSM WAS EFFECTIVELY EMBOLIZED. THE PHYSICIAN DOES NOT FEEL THE INCIDENT WAS ASSOCIATED WITH THE PULSERIDER DEVICE. CONCOMITANT DEVICES INCLUDE A 7F

  Patient problems: Obstruction/Occlusion

  MAUDE report 7295625 ↗
• DeathDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PULSERIDER (301D/ W262306) ASSISTED COIL EMBOLIZATION PROCEDURE OF A RECANALIZED BASILAR TIP ANEURYSM (PREVIOUS COILS UNKNOWN), THE ANEURYSM WAS RUPTURED BY THE TINES OF THE PULSERIDER. IT WAS REPORTED THAT THE VESSEL WAS MODERATELY TORTUOUS AND THE ANEURYSM WAS NOT RUPTURED PRIOR TO THE PROCEDURE. THE PULSERIDER WAS REPOSITIONED TWICE TO GET IT IN THE LEFT PCA AND INSIDE THE ANEURYSM ON THE RIGHT SIDE-THE TAKEOFF OF THE PCA¿S WAS A LITTLE DIFFICULT. THE ANEURYSM WAS COILED WITH NON-CODMAN COILS. THE PATIENT WAS STABLE THE ENTIRE TIME AND THERE WAS NO CHANGE IN THE PATIENT¿S VITALS. THE RUPTURE WAS ONLY DISCOVERED WHEN DOING A RUN AFTER THE PROCEDURE. ADDITIONAL COILS WERE IMPLANTED WITH BALLOON ASSISTANCE, AND THE BLEEDING SUBSIDED. THE PATIENT WAS DOING FINE; HOWEVER, AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED TO RELIEVE PRESSURE THAT WAS PLACED DUE TO THE RUPTURE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS.

  Patient problems: Aneurysm; Death; Hemorrhage, Subarachnoid; Intracranial Hemorrhage; Rupture

  MAUDE report 7150256 ↗
• MalfunctionDec 27, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PULSERIDER Y 3MM, 8MM ARCH (301D/W2607-01) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WOULD NOT ADVANCE INTO THE PROWLER SELECT MICROCATHETER (606SXXX/UNKNOWN LOT). THE PROWLER SELECT MICROCATHETER WAS EXCHANGED WITHOUT SUCCESS. THE PULSERIDER ANRD WAS SUBSEQUENTLY REPLACED. THE REPLACEMENT PULSERIDER ANRD COULD BE ADVANCED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY. THE DEVICES WERE PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PULSERIDER ANRD WILL BE RETURNED FOR ANALYSIS.THE PROWLER SELECT MICROCATHETER WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148564 ↗