ULTIPAQ FSR100308-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528001638), received between Jul 19, 2017 and Sep 16, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another 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.

• MalfunctionSep 16, 2021Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA), RESISTANCE WAS ENCOUNTERED WHEN TRYING TO INTRODUCE THE ULTIPAQ 10 SR, 3MMX8CM COIL ((B)(4)) INTO THE UNSPECIFIED MICROCATHETER (MC). THE USER REPORTED THAT THE RESISTANCE WAS FELT AT THE MC/RHV/INTRODUCER SHEATH JUNCTION WHEN TRYING TO TRANSFER THE COIL FROM INTRODUCER SHEATH TO MC. THE DEVICE NEVER ENTERED THE MC. SHE ALSO REPORTS A BREACH IN THE SHEATH UPON REMOVAL AND INSPECTION. THIS WAS NOTICED BEFORE COIL ENTERED INTO THE MC. THERE WAS NO EFFECT TO THE CASE OR PATIENT¿S OUTCOME. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482024 ↗
• InjuryJul 19, 2017Migration or Expulsion of Device; Material Separation; Stretched; Device Damaged by Another Device; Migration or Expulsion of Device; Material Separation; Stretched; Device Damaged by Another Device

  AS REPORTED BY A PHYSICIAN, DURING COIL EMBOLIZATION OF A 5MM (NECK 3MM) ANTERIOR COMMUNICATING ARTERY ANEURYSM, AFTER SUCCESSFUL DEPLOYMENT OF THE FIRST COIL, A 4MM X 15CM MICRUSPHERE (SPH10040020/C31600), AN ULTIPAQ 3MM X 8CM (CATALOG FSR10030820/C27386) MILDLY BULGED INTO THE PARENT ARTERY. IT WAS DECIDED TO WITHDRAW THE COIL; HOWEVER, WHILE TAKING IT OUT, THE COIL WAS ENTANGLED WITH THE PREVIOUS COIL, STRETCHED AND SEPARATED WITH THE PROXIMAL END SEEN IN THE THORACIC AORTA AND THE DISTAL END IN THE ANEURYSMAL CAVITY, RESULTING IN REDUCTION OF BLOOD FLOW THROUGH THE ARTERY. WHILE TAKING OUT THE EXCELSIOR SL 10 (1.7F DISTAL END) MICROCATHETER WITH THE COIL, THE WHOLE COIL MASS MOVED AND MIGRATED INTO THE PARENT ARTERY. THE ATTEMPT TO REPLACE THE COIL MASS USING A PUSHER WIRE AND MICROWIRE WERE INEFFECTIVE. THERE WAS PARTIAL REPOSITIONING BY BALLOON ANGIOPLASTY WITH A SCEPTER BALLOON; HOWEVER, THE COILS REMAINED IN THE PATIENT WITH THE PROXIMAL END OF THE ULTIPAQ FLOATING WITHIN THE THORACIC AORTA. WHEN THE PATIENT WAS EXTUBATED, SHE WAS NOT ABLE TO MOVE HER RIGHT ARM AND LEG. THE PATIENT WAS RE-CANNULATED AND FOUND TO HAVE THROMBOGENIC A1 OCCLUSION AND WAS POTENTIALLY MORE VULNE

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA; Thrombosis

  MAUDE report 6724976 ↗