CERECYTE PRESIDIO PC4181447-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528003267), received between Oct 7, 2016 and May 18, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

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.

• MalfunctionMay 18, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, PRESIDIO 18 CERE COIL 14MMX47CM (PC418144730, L11951) BECAME IMPEDED. IT COULDN'T ADVANCE WITHIN THE UNSPECIFIED MICRO CATHETER (MC). NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842108 ↗
• MalfunctionOct 7, 2016Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM (15MM IN SIZE) AT HEPATIC ARTERY TWO PRESIDIO COILS (PC4181550-30/C35982, PC4181447-30/C34163) AN ORBIT GALAXY COIL (640CF0721/17383916) WERE STUCK IN THE MICROCATHETER. THE ENPOWER CONTROL CABLE WAS NOT CLEAN UPON OPENING HOWEVER DID NOT PROVIDE ANY REASON. THE LOCATION THAT THE DEVICE WAS NOT CLEAN IS UNKNOWN HOWEVER THE ISSUE WAS NOT DISCOVERED DURING OPENING. THE PATIENT WAS A MALE OF UNKNOWN AGE; THE LEVEL OF TORTUOUSITY WAS HEAVY, AND NO CALCIFICATION OF THE VESSELS. A SHEATH INTRODUCER (TERUMO), A GUIDEWIRE (ASAHI), A PROGREAT MICROCATHETER (TERUMO), A LIGHTHOUSE (PIOLAX), AND A Y CONNECTOR (TERUMO) WERE USED FOR THIS PROCEDURE. THE COMPLAINT PRESIDIO COILS WERE THE FIRST TWO COILS USED IN THE PROCEDURE. THE FIRST COIL WAS STUCK AT THE DISTAL AREA IN THE MICROCATHETER (MC), AND IT WAS RETRIEVED. THE RESISTANCE WAS STRONG WHILE RETRIEVING AS WELL. THE SECOND COIL WAS STUCK IN THE MIDDLE OF MC DURING MC PLACEMENT. IT DIDNMOVE AT ALL AND RETRIEVED WHEN THE MC WAS RETRIEVED. THEN MC WAS REPLACED AND THE PROCEDURE CONTINUED. THE COMPLAINT GALAXY WAS USED AFTER THE PHYSICIAN INSERTED MORE T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6011644 ↗