CERECYTE PRESIDIO PC4181550-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528003274), received between Sep 14, 2016 and May 5, 2017 — classified as 2 malfunctions.

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

• MalfunctionMay 5, 2017Unraveled Material; Physical Resistance; Unraveled Material; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT INTERNAL ILIAC ARTERY, THERE WAS DIFFICULTY WITH THE PROWLER SELECT PLUS ((B)(4)) HANDLING, BUT FINALLY THE MICROCATHETER WAS PLACED; HOWEVER A PRESIDIO ((B)(4)) WAS GOT STUCK IN THE MICROCATHETER AND THE PHYSICIAN WITHDREW THE COIL IN THE MICROCATHETER, BUT THE COIL UNRAVELED. THE COIL WAS REPLACED WITH ANOTHER ONE. FIVE COILS (PRESIDIO/CASHMERE) WERE USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED OR PROCEDURE DELAY. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCTS WERE NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6547083 ↗
• MalfunctionSep 14, 2016Failure to Advance; 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'T 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 THAN 1

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5951542 ↗