HydroSoft 3D 7110-0102-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777025319), received between Sep 12, 2018 and Nov 14, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE RAGE STUDY THAT A SMALL TRIANGULAR ACOMM ANEURYSMAL REMNANT POST PREVIOUS COILING WITH SUBSEQUENT COIL MIGRATION INTO THROMBUS. THE SUBJECT UNDERWENT RETREATMENT WITH THE PLACEMENT OF A FLOW DIVERTER. THE COIL MIGRATION INTO THROMBUS WAS NOTED DURING THE RETREATMENT PROCEDURE ON (B)(6) 2020. THE PATIENT COMPLETED THE STUDY ON THE SAME DATE (B)(6) 2020) AND WAS EXITED FROM THE STUDY. PREVIOUS COILING PROCEDURE DATE: (B)(6) 2019 ANEURYSM LOCATION: ANTERIOR COMMUNICATING ARTERY ANEURYSM SIDE: MIDLINE HEIGHT: 2.4MM, WIDTH: 3.3MM, DEPTH: 4.8MM, NECK SIZE: 2.4MM, DOME TO NECK RATIO: 1.38MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689580 ↗
• MalfunctionNov 3, 2024Premature Separation; Premature Separation

  PLEASE SEE H6 & H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595772 ↗
• InjurySep 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A BALLOON-ASSISTED COILING PROCEDURE WAS PERFORMED ON A PATIENT WITH A RECURRENT BASILAR TIP SACCULAR ANEURYSM. AFTER DELIVERY OF A BALLOON CATHETER INTO THE POSTERIOR CEREBRAL ARTERY, TWO COILS WERE SUCCESSFULLY PLACED IN THE ANEURYSM. SUBSEQUENTLY, A COIL LOOP WAS NOTED TO PROJECT AT THE BASILAR BIFURCATION, MORE TOWARDS THE ORIGIN OF THE RIGHT P1 ARTERY. THE BALLOON WAS INFLATED MULTIPLE TIMES, WHICH REPOSITIONED THE COIL MASS AND CENTRALIZED THE COIL LOOP AT THE BASILAR BIFURCATION. BOTH POSTERIOR CEREBRAL ARTERIES WERE PATENT. THE DECISION WAS MADE TO STOP TREATMENT AT THAT POINT AND MAINTAIN THE PATIENT ON DUAL ANTIPLATELET THERAPY FOR 3 MONTHS. THE PATIENT AWOKE FROM GENERAL ANESTHESIA NEUROLOGICALLY INTACT AND WAS REPORTED TO BE STABLE WITH NO NEW NEUROLOGICAL DEFICITS UPON HOSPITAL DISCHARGE. THE PATIENT IS ENROLLED IN A POST-MARKET CLINICAL TRIAL AND IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7871435 ↗