CERECYTE PRESIDIO PC4100730-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00878528003038), received between May 5, 2017 and Mar 23, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A CEREBRAL ANEURYSM, THE COIL INTRODUCER OF THE 7MM X 30CM PRESIDIO 10 CERECYTE COIL (PC410073030 / L15246) WAS IMPEDED AT THE DISTAL TIP OF THE HEADWAY® 21 MICROCATHETER (MICROVENTION-TERUMO); THERE WAS RESISTANCE ENCOUNTERED AT THE DISTAL TIP OF THE MICROCATHETER. THE REPORTED ISSUE OCCURRED WHEN THE PHYSICIAN WAS ACCESSING THE MICROCATHETER THROUGH THE COIL INSERTER. THE COIL WAS REPLACED WITH THE 6MM X 25CM DELTAMAXX CERECYTE COIL (CDX18062530 / S14432) BUT THE SAME ISSUE WAS ENCOUNTERED. THE COIL INTRODUCER OF THIS REPLACEMENT COIL BECAME IMPEDED IN THE MICROCATHETER. A THIRD COIL WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE TARGET POSITION WAS NOT LOST AS THE CONCOMITANT HEADWAY® 21 MICROCATHETER REMAINED IN THE TARGET LESION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS 3/18/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868342 ↗
• MalfunctionOct 15, 2019Difficult to Remove; Difficult to Remove

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE DOCTOR DEPLOYED THE 7MMX30CM PRESIDIO 10 CERE COIL (PC410073030, UNKNOWN LOT) THROUGH AN UNKNOWN PROWLER LP ES MICROCATHETER (MC). AFTER DEPLOYING THE COIL FULLY, THE MICROCATHETER KICKED BACK. THE DOCTOR TRIED TO REPOSITION THE CATHETER SO HE TRIED TO PULL BACK AND RE SHEATH THE COIL SO THAT HE CAN REPOSITION THE CATHETER. THE DOCTOR HAD DIFFICULTY IN PULLING BACK THE COIL INSIDE THE CATHETER, THEREFORE, AFTER SOME ATTEMPTS HE PULLED BOTH THE MICROCATHETER AND COIL OUTSIDE THE SYSTEM. THEN HE REPOSITIONED THE CATHETER WITH THE GUIDE WIRE AGAIN AND FINISHED THE CASE WITH COMPETITOR¿S COILS. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192585 ↗
• MalfunctionOct 30, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE USER ENCOUNTERED RESISTANCE WHILE ADVANCING THE 6MM X 26CM PRESIDIO 10 CERE (PC410062630/C35483), 7MM X 30CM PRESIDIO 10 CERE (PC410073030/S10163), AND THE 7MM X 20CM MICRUSPHERE XL (SSR10072020/S13782) THROUGH THE PROXIMAL SHAFT OF THE PROWLER SELECT PLUS (606S255X/17674174) MICROCATHETER. THE ISSUE REQUIRED THAT THE COILS BE REMOVED AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURAL DELAY WAS LESS THAN 30 MINUTES. THE DEVICES WERE PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONCOMITANT MICROCATHETER DID NOT KINK OR BEND AT ANY TIME. A 10MM X 34CM PRESIDIO COIL AND COMPETITOR COILS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO AND FOLLOWING THE ENCOUNTERED RESISTANCE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL PORTION OF THE 6MM X 26CM PRESIDIO EMBOLIC COIL WAS KINKED, THE DISTAL PORTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019876 ↗
• MalfunctionApr 23, 2018Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, THE 7MM X 30CM PRESIDIO 10 CERE ((B)(4)) THERMO-MECHANICAL COIL COULD NOT BE DETACHED. THE COIL WAS SUBSEQUENTLY WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. THE COIL WAS NEITHER STRETCHED NOR KINKED. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. AN ENPOWER DETACHMENT CONTROL BOX (DCB) AND CONTROL CABLE WERE USED FOR THE CASE. THE SAME DCB AND CONTROL CABLE WERE USED TO DETACH SUBSEQUENT COILS. THE DEVICE WILL BE RETURNED FOR ANALYSIS. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. NEITHER A ¿LOW BATTERY¿ LIGHT NOR A ¿FAULT¿ LIGHT WAS VISUALIZED DURING THE PROCEDURE. THE GREEN ¿SYSTEM READY¿ LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER. THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT OF T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451845 ↗
• MalfunctionOct 2, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PRESIDIO 10 COIL (PC410073030/C41214) STRETCHED DURING THE PROCEDURE. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6907986 ↗
• MalfunctionSep 7, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE PRESIDIO 10 COIL (B)(4)COULD NOT BE DETACHED. THEY EXCHANGED THE COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849653 ↗
• MalfunctionMay 11, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCED A DELTAPLUSH (CPL10015330/ C40127), A DELTAPAQ (CDF10020430/ C33041) AND A PRESIDIO (PC410073030/ C41431) THROUGH A HEADWAY 17 MICROCATHETER. UPON RETURN OF THE DEVICES FOR ANALYSIS, THE DELTAPLUSH AND DELTAPAQ COILS WERE FOUND TO BE COMPRESSED AND BUCKLED AND THE PRESIDIO COIL WAS STRETCHED. OTHER COILS WERE ABLE TO BE ADVANCED. THE PHYSICIAN REPLACED THE COILS WITH SAME LIKE PRODUCTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO POTENTIAL ADVERSE EVENTS. AFTER MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559787 ↗
• MalfunctionMay 10, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ENVOY DA CATHETER (67125805D/ E11363) WAS KINKED WHEN IT WAS FIRST OPENED, A DELTAPAQ INTRODUCER (CDF10051030/ C38958) FAILED TO RE-ZIP DURING RE-SHEATHING AND WAS FOUND TO BE STRETCHED DURING PRODUCT ANALYSIS, AND THERE WAS RESISTANCE DURING ADVANCEMENT OF A PRESIDIO COIL (PC410073030/ C37141) THROUGH THE UNSPECIFIED MICROCATHETER AND THE DEVICE WAS RETURNED WITH THE COIL PREMATURELY DETACHED. THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT AND DECIDED TO PULL IT OUT, BUT DURING RE-SHEATHING THE COIL INTRODUCER FAILED TO RE-ZIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SAME/LIKE PRODUCTS. THERE WERE NO POTENTIAL ADVERSE EVENTS. AFTER MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556758 ↗
• MalfunctionMay 5, 2017Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE EMBOLIZATION PROCEDURE A PRESIDIO10 CERE 7MM X 30CM AND PRESIDIO10 CERE 6MM X 26CM AND A COIL WERE BLOCKED IN AN UNKNOWN MICROCATHETER. THE PROCEDURE WAS COMPLETED USING SAME LIKE PRODUCTS. THERE WERE NO ADVERSE EVENTS. IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF SUBARACHNOID HEMORRHAGE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE COMPLAINT PRODUCTS ARE AVAILABLE FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6548663 ↗