DELTAPAQ CERECYTE CDF100152-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00878528007012), received between Aug 29, 2016 and Feb 5, 2024 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Stretched” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30432657) BECAME IMPEDED IN AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MC. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND OBSERVED THAT THE COIL WAS UNRAVELED/STRETCHED. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640125 ↗
• MalfunctionJan 18, 2024Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL ((B)(6)) FOR INSPECTION AND FOUND THAT THE COIL WAS SEPARATED IN THE INTRODUCER SHEATH. THE COIL WAS NOT USED IN THE PATIENT. A NEW COIL WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 18-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537126 ↗
• MalfunctionJan 17, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / 30436874). IT WAS REPORTED THAT THE COIL WAS FOUND UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 17-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528542 ↗
• MalfunctionJan 16, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS, A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) AND A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30432657) BECAME UNRAVELED/STRETCHED. A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JAN-2024 INDICATED THAT THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED ON THE DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874. THE SAME DETACHABLE CONTROL BOX (DCB) AND CONTROL CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. REGARDING THE UNRAVELED COILS, IT IS UNKNOWN WHEN THE COILS BECAME UNRAVELED/STRETCHED. THERE HAD BEEN NO RESISTANCE/FRICTION BETWEEN THE COIL AND ANOTHER DEVICE PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518587 ↗
• MalfunctionJan 16, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS, A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) AND A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30432657) BECAME UNRAVELED/STRETCHED. A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JAN-2024 INDICATED THAT THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED ON THE DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874. THE SAME DETACHABLE CONTROL BOX (DCB) AND CONTROL CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. REGARDING THE UNRAVELED COILS, IT IS UNKNOWN WHEN THE COILS BECAME UNRAVELED/STRETCHED. THERE HAD BEEN NO RESISTANCE/FRICTION BETWEEN THE COIL AND ANOTHER DEVICE PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518581 ↗
• MalfunctionJan 16, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS, A DELTAPAQ CERE 1.5MMX2CM COIL, (CDF10015230, 30436874) AND A DELTAPAQ CERE 1.5MMX2CM COIL, (CDF10015230, 30432657) BECAME UNRAVELED/STRETCHED. A DELTAPAQ CERE 1.5MMX2CM COIL. (CDF10015230, 30436874) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JAN-2024 INDICATED THAT THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED ON THE DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874. THE SAME DETACHABLE CONTROL BOX (DCB) AND CONTROL CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. REGARDING THE UNRAVELED COILS, IT IS UNKNOWN WHEN THE COILS BECAME UNRAVELED/STRETCHED. THERE HAD BEEN NO RESISTANCE/FRICTION BETWEEN THE COIL AND ANOTHER DEVICE PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518579 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / 30436874) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509185 ↗
• MalfunctionJun 15, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN TRIED TO ADVANCE A 1.5MMX2CM DELTAPAQ CERE COIL 1.5MMX2CM (CDF10015230, L15223) THROUGH AN EXCELSIOR SL10, STRYKER 45 DEGREE MICROCATHETER (MC) BUT IT WAS DIFFICULT DUE TO SOME RESISTANCE. THEREFORE, THE USER PULLED THE COMPLAINT COIL THROUGH THE MC. THERE WAS NO PATIENT INJURY, AND THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE COMPLAINT COIL WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THERE WAS NO DAMAGE TO THE MC DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE COMPLAINT COIL DID NOT APPEAR TO HAVE ANY DAMAGE AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER 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 DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001821 ↗
• MalfunctionOct 2, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MMX2CM DELTAPAQ CERE COIL (CDF10015230, L10006) WAS BEING USED AS THE LAST COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT, AND DECIDED TO PULL IT OUT. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619003 ↗
• MalfunctionSep 9, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MMX2CM DELTAPL CERE COIL (CDF10015230, S12356) WAS BEING USED AS A SECOND COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING THE RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507915 ↗
• MalfunctionAug 25, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MMX2CM DELTAPAQ CERE COIL (CDF10015230, S14521) WAS BEING USED AS THE FIRST COIL. THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10447774 ↗
• MalfunctionAug 11, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / S10905) WAS THE FIRST COIL USED; WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, THE AUDIBLE BEEP OF THE DETACHMENT CYCLE WAS HEARD, BUT WHEN THE PHYSICIAN WAS RETRIEVING THE DELIVERY SYSTEM, THE COIL FAILED TO DETACH. THE PHYSICIAN USED ANOTHER 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL AS A REPLACEMENT COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT COMPLICATION OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393929 ↗
• MalfunctionNov 13, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5MMX2CM DELTAPAQ CERE COIL (CDF10015230, S11022) WAS BEING USED AS A SECOND COIL ON THE CASE. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RE-SHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314492 ↗
• MalfunctionOct 2, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5MMX2CM DELTAPAQ CERE COIL (CDF10015430, S14242) WAS BEING USED AS THE FIRST COIL, HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNKNOWN MICROCATHETER AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147661 ↗
• MalfunctionOct 2, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5MMX2CM DELTAPAQ CERE COIL (CDF10015230, S11954) WAS BEING USED AS A THIRD COIL, HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNKNOWN MICROCATHETER AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147511 ↗
• MalfunctionApr 25, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / LOT# UNKNOWN) COULD NOT BE RESHEATHED. THE REPORTED EVENT DELAYED THE PROCEDURE BY 10 MINUTES. THERE WAS NO REPORT OF PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE PRODUCT WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/25/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8553169 ↗
• MalfunctionApr 1, 2019Separation Failure; Separation Failure

  A REPORT FROM THE FIELD INDICATED THAT THE GREEN ¿SYSTEM READY¿ LIGHT DID NOT ILLUMINATE WHEN THE 1.5 MM X 2 CM DELTAPAQ (CDF10015230/UNK LOT) COIL WAS CONNECTED TO THE ENPOWER DETACHMENT CONTROL BOX (DCB). THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. IT WAS NOT REPORTED IF THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470349 ↗
• MalfunctionFeb 15, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, WHEN THE 1.5 MM X 2 CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / C36943) REACHED THE TARGET LESION, THE PHYSICIAN REPORTED THAT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN SUCCESSFULLY WITHDREW AND REPLACED THE COIL TO COMPLETE THE PROCEDURE WITHOUT LOSING THE TARGET POSITION. THERE WAS NO DIFFICULTY DURING THE PREP OF THE COIL DELIVERY SYSTEM. IT WAS REPORTED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM AND NOT STRETCHED WHEN IT WAS REMOVED. THE REPORTED EVENT DID NOT RESULT IN ANY INTERRUPTION OF BLOOD FLOW OR IN ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. IT WAS REPORTED THAT THE DELTAPAQ 10 CERECYTE COIL IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345069 ↗
• MalfunctionJan 14, 2019Stretched; Material Twisted/Bent; Physical Resistance/Sticking; Stretched; Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ANEURYSM, THE PHYSICIAN USED THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC) TO REACH THE TARGET AND SUCCESSFULLY IMPLANTED FOUR COILS. ON THE FIFTH COIL, THE PHYSICIAN REPORTED THAT THE 1.5 MM X 2 CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / C40841) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE PHYSICIAN EXCHANGED THE COIL AND THE MICROCATHETER WITH ANOTHER ECHELON¿ 10 AND ENCOUNTERED THE SAME ISSUE. THE REPLACEMENT COIL COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE SAME ISSUE OCCURRED THREE TIMES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND DIFFERENT COIL (UNKNOWN BRAND). THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE REPORTED ISSUE DID NOT CAUSE ANY PROCEDURAL DELAY. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246229 ↗
• MalfunctionJan 14, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ANEURYSM, THE PHYSICIAN USED THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC) TO REACH THE TARGET AND SUCCESSFULLY IMPLANTED FOUR COILS. ON THE FIFTH COIL, THE PHYSICIAN REPORTED THAT THE 1.5 MM X 2 CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / C39900) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE PHYSICIAN EXCHANGED THE COIL AND THE MICROCATHETER WITH ANOTHER ECHELON¿ 10 AND ENCOUNTERED THE SAME ISSUE. THE REPLACEMENT COIL COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE SAME ISSUE OCCURRED THREE TIMES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND DIFFERENT COIL (UNKNOWN BRAND). THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE REPORTED ISSUE DID NOT CAUSE ANY PROCEDURAL DELAY. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246226 ↗
• MalfunctionJan 14, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ANEURYSM, THE PHYSICIAN USED THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC) TO REACH THE TARGET AND SUCCESSFULLY IMPLANTED FOUR COILS. ON THE FIFTH COIL, THE PHYSICIAN REPORTED THAT THE 1.5 MM X 2 CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / C40841) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE PHYSICIAN EXCHANGED THE COIL AND THE MICROCATHETER WITH ANOTHER ECHELON¿ 10 AND ENCOUNTERED THE SAME ISSUE. THE REPLACEMENT COIL COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE SAME ISSUE OCCURRED THREE TIMES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND DIFFERENT COIL (UNKNOWN BRAND). THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE REPORTED ISSUE DID NOT CAUSE ANY PROCEDURAL DELAY. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246214 ↗
• MalfunctionJan 10, 2019Material Separation; Material Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT OF THE 1.5MM X 2CM DELTAPAQ (CDF10015230/UNK LOT) AND THE 1.5MM X 3CM DELTAPLUSH 10 (CPL10015330/UNK LOT) AND DECIDED TO REMOVE THE COILS FROM THE PATIENT; HOWEVER, WHILE RESHEATHING THE COILS, THE INTRODUCERS FAILED TO BE REZIPPED. THE COILS WERE REPLACED WITH SAME-LIKE COILS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. EVALUATION OF THE RETURNED DEVICES REVEALED EMBOLIC COIL DAMAGE. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8233721 ↗
• MalfunctionSep 26, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE DELTAPAQ 10 CERECYTE COIL 1.5MM X 2CM COIL (CDF10015230 / C40841) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER (UNKNOWN BRAND). ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910225 ↗
• MalfunctionMar 20, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, THE 1.5MM X 2CM DELTAPAQ THERMO-MECHANICAL DETACHABLE COIL SYSTEM (CDF10015230/C36943) COULD NOT BE ADVANCED THROUGH THE UNSPECIFIED MICROCATHETER. THE COIL WAS SUBSEQUENTLY REPLACED. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS OBSERVED. THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE PROCEDURE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE ASSOCIATED MICROCATHETER IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352866 ↗
• MalfunctionOct 17, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPAQ COIL (CDF10015230/C40841) WAS USED DURING A PROCEDURE WHEN THE COIL COULD NOT BE DETACHED. ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954305 ↗