HydroSoft Helical 100206H2HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777022899), received between Oct 18, 2018 and Jul 31, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT FOR A RUPTURED POSTERIOR COMMUNICATING (PCOM) ANEURYSM, THE MICROCATHETER WAS POSITIONED INSIDE THE ANEURYSM OVER A TRAXCESS WIRE. AFTER DEPLOYING A COUPLE OF COILS, RESISTANCE WAS FELT WHILE PUSHING THE HYDROSOFT COIL INSIDE THE MICROCATHETER, AND THE PHYSICIAN DECIDED TO RE-SHEATH THE COIL. AFTER PULLING BACK THE PUSHER WIRE INTO THE COIL INTRODUCER SHEATH, IT WAS OBSERVED THE COIL HAD DETACHED INSIDE THE MICROCATHETER AND ONLY THE PUSHER WIRE WAS RETRIEVED. A FEW RUNS REVEALED 90% ANEURYSM OCCLUSION, SO THE PHYSICIAN DECIDED TO WITHDRAW THE MICROCATHETER AND STOP THE PROCEDURE. THE PATIENT WAS SHIFTED TO THE ICU POST PROCEDURE AND LATER DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431292 ↗
• MalfunctionDec 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED THROUGH THE RAGE STUDY, A PATIENT WITH A HISTORY OF HYPERTENSION AND HYPOTHYROIDISM PRESENTED WITH A ONE DAY HISTORY OF HEADACHES AND CONFUSION. THE PATIENT WAS FOUND TO HAVE DIFFUSE SUBARACHNOID HEMORRHAGE WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM ON CTA. THE PATIENT UNDERWENT ENDOVASCULAR, BALLOON ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH EXCELLENT OBLITERATION OF ANEURYSM, CONSISTENT WITH RAYMOND ROY GRADE 1. THE PROCEDURE WAS COMPLICATED BY INTRAPROCEDURAL RUPTURE. REPORTEDLY, FOLLOWING INSERTION OF A HYDROFRAME 5MM X 10CM EMBOLIZATION COIL IMPLANT (SEE MDR 2032493-2021-00502) , THE COIL WAS NOTED TO BE PARTIALLY PROTRUDING THROUGH THE ANEURYSM WALL INTO THE SUBARACHNOID SPACE. A TRANSFORM BALLOON WAS INFLATED AND A SECOND COIL WAS RAPIDLY PLACED WITHOUT EVIDENCE OF EXTRAVASATION ON THE FOLLOWING INJECTION. THE LAST COIL IMPLANT PARTIALLY HERNIATED INTO THE ANTERIOR COMMUNICATING ARTERY, BUT WITHOUT EVIDENCE OF SURROUNDING THROMBOSIS OR FLOW LIMITATION. DYNA CT SHOWED EVIDENCE OF NEW HEMORRHAGE, HOWEVER, WITH MILD HYDROCEPHALUS NECESSITATING EVD INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015994 ↗
• MalfunctionOct 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING RE-POSITIONING OF THE COIL IN THE ANEURYSM, THE COIL DETACHED WITHOUT USE OF THE CONTROLLER. THE COIL REMAINS IMPLANTED IN THE ANEURYSM. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY AS A RESULT OF THE ISSUE. THE PATIENT WAS REPORTED TO BE OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979388 ↗