TRUFILL DCS ORBIT 637CF0615Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704029465), received between Jun 20, 2017 and Jun 20, 2017 — 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.

• InjuryJun 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE ARTICLE ¿UNUSUAL DELAYED HYDROCEPHALUS AFTER BARE PLATINUM COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM¿ BY KOUICHI MISAKI, NAOYUKI UCHIYAMA, MASANOA MOHRI, YUICHI HIROTA, YUTAKA HAYASHI, JUN-ICHIRO HAMADA, PUBLISHED NEUROL MED CHIR (TOKYO) 50, 581-585, 2010, THE AUTHORS PRESENT A CASE OF A PATIENT WHO DEVELOPED HYDROCEPHALUS AFTER EMBOLIZATION OF AN INCIDENTALLY DETECTED UNRUPTURED LARGE INTERNAL CAROTID ARTERY ANEURYSM WITH BARE PLATINUM COILS INCLUDING TWO ORBIT COMPLEX FILL COILS (CATALOG 637CF0615, LOTS 13297196 AND 13259950). A (B)(6)-YEAR-OLD WOMAN WAS ADMITTED FOR ENDOVASCULAR TREATMENT OF AN INCIDENTALLY DETECTED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY. MAGNETIC RESONANCE IMAGING REVEALED NO ANEURYSMAL THROMBUS FORMATION AND NO PERI-ANEURYSMAL BRAIN EDEMA, AND NO EVIDENCE OF SUBARACHNOID HEMORRHAGE, VENTRICULAR OBSTRUCTION, OR NEOPLASM. THREE DAYS PRIOR TO THE PROCEDURE ADMINISTRATION OF ASPIRIN (100MG/DAY) WAS BEGUN. ENDOVASCULAR OCCLUSION WAS PERFORMED UNDER GENERAL ANESTHESIA, AND SYSTEMIC HEPARINIZATION. FIFTEEN GUGLIELMI DETACHABLE COILS (GDC18: 280 CM, GDC10: 220 CM) AND TWO ORBIT COILS WITH A TOTAL LENGTH OF 515 CM WERE POSITIONED IN THE ANEURY

  Patient problems: Hydrocephalus

  MAUDE report 6653546 ↗
• InjuryJun 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE ARTICLE ¿UNUSUAL DELAYED HYDROCEPHALUS AFTER BARE PLATINUM COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM¿ BY KOUICHI MISAKI, NAOYUKI UCHIYAMA, MASANOA MOHRI, YUICHI HIROTA, YUTAKA HAYASHI, JUN-ICHIRO HAMADA, PUBLISHED NEUROL MED CHIR (TOKYO) 50, 581-585, 2010, THE AUTHORS PRESENT A CASE OF A PATIENT WHO DEVELOPED HYDROCEPHALUS AFTER EMBOLIZATION OF AN INCIDENTALLY DETECTED UNRUPTURED LARGE INTERNAL CAROTID ARTERY ANEURYSM WITH BARE PLATINUM COILS INCLUDING TWO ORBIT COMPLEX FILL COILS (CATALOG 637CF0615, LOTS 13297196 AND 13259950). A (B)(6) WOMAN WAS ADMITTED FOR ENDOVASCULAR TREATMENT OF AN INCIDENTALLY DETECTED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY. MAGNETIC RESONANCE IMAGING REVEALED NO ANEURYSMAL THROMBUS FORMATION AND NO PERI-ANEURYSMAL BRAIN EDEMA, AND NO EVIDENCE OF SUBARACHNOID HEMORRHAGE, VENTRICULAR OBSTRUCTION, OR NEOPLASM. THREE DAYS PRIOR TO THE PROCEDURE ADMINISTRATION OF ASPIRIN (100MG/DAY) WAS BEGUN. ENDOVASCULAR OCCLUSION WAS PERFORMED UNDER GENERAL ANESTHESIA, AND SYSTEMIC HEPARINIZATION. FIFTEEN GUGLIELMI DETACHABLE COILS (GDC18: 280 CM, GDC10: 220 CM) AND TWO ORBIT COILS WITH A TOTAL LENGTH OF 515 CM WERE POSITIONED IN THE ANEURYSM. POST-

  Patient problems: Hydrocephalus

  MAUDE report 6653487 ↗