DELTAPLUSH CERECYTE CPL100153-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00878528008194), received between Oct 12, 2016 and Jun 21, 2021 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Stretched” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K083646); they may or may not involve this specific model.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, THE PHYSICIAN TRIED TO RESHEATH A DELTAPL CERE COIL 10 SYS 1.5X3 COIL (CPL10015330, L15233) AFTER DECIDING THAT THE CHOSEN COIL WAS AN UNPROPER CHOICE DURING THE PROCEDURE. HOWEVER, THE RESHEATH FAILED AND INTRODUCER SHEATH WAS ¿SPLIT¿. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. THE ONLY THE COMPLAINT COIL WAS REMOVED EASILY FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS OBSERVED STRETCHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036798 ↗
• MalfunctionFeb 10, 2021Device Difficult to Setup or Prepare; Stretched; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Stretched; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RESHEATH THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL (CPL10015330 / L15226) AFTER DECIDING THAT THE COIL WAS NOT THE PROPER CHOICE FOR THE PROCEDURE, BUT THE COIL FAILED TO RESHEATH AND THE INTRODUCER SHEATH BECAME SPLIT. THERE WAS NO RESISTANCE BETWEEN THE COMPLAINT COIL AND THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER); THERE WAS NO ISSUE WITH THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT WITHOUT ANY INTERVENTION AND WITHOUT LOSS OF TARGET POSITION. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED EVENT. 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 AND MECHANICALLY DETACHED. BASED ON THE PRODUCT ANALYSIS ON 10 FEBRUARY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311793 ↗
• MalfunctionDec 5, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5X3 DELTAPL CERE 10 COIL FAILED TO RESHEATHED. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418367 ↗
• MalfunctionAug 13, 2019Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL (CPL10015330 / C27603), THE AUDIBLE BEEP OF THE DETACHMENT CYCLE WAS HEARD AS EXPECTED, BUT DURING THE RETRIEVAL ATTEMPT OF THE DELIVERY SYSTEM, THE COIL BECAME PROTRUDED FROM THE INTRODUCER SHEATH. ANOTHER 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL WAS USED 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 8889430 ↗
• MalfunctionApr 24, 2019Stretched; Material Deformation; Stretched; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM AT AN UNKNOWN TARGET SITE, THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL (CPL10015330 / S14308) BECAME IMPEDED IN THE ECHELON® 10 MICROCATHETER (MEDTRONIC) AND COULD NOT BE ADVANCED IN THE MICROCATHETER; AS A RESULT, THE PROTECTIVE SHEATH BECAME DAMAGED; THE COIL INTRODUCER WAS NOT DAMAGED. ANOTHER 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL FROM THE SAME LOT WAS USED AND THE SAME ISSUE WAS ENCOUNTERED. A THIRD COIL, A 1.5 MM X 3 CM AXIUM¿ COIL (MEDTRONIC) WAS USED AND WAS SUCCESSFULLY IMPLANTED. THERE WAS NO LOSS OF TARGET POSITION; THE REPORTED EVENT DID NOT REQUIRE THAT THE COIL AND THE MICROCATHETER BE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT INJURY, COMPLICATION AND WITHOUT ANY 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. THE PRODUCTS WERE RETURNED FOR EVALUATION WHICH REVEALED THAT ONE OF THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COILS WAS IN A DAMAGED CONDITION. BASED ON THE PRODUCT A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547440 ↗
• MalfunctionJan 14, 2019Premature Separation; Premature 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), 1.5MM X 3CM DELTAPLUSH 10 (CPL10015330/UNK LOT), AND THE 5MM X 9.7CM MICRUSPHERE 10 (CSP10050030/UNK LOT) AND DECIDED TO REMOVE THE COILS FROM THE PATIENT; HOWEVER, WHILE RESHEATHING THE COILS, THE INTRODUCERS FAILED TO BE REZIPPED. THE COIL WAS REPLACED WITH A SAME-LIKE COIL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. EVALUATION OF THE RETURNED DELTAPLUSH REVEALED PREMATURE DETACHMENT OF THE EMBOLIC COIL. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246075 ↗
• MalfunctionJan 11, 2019Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT OF THE 2MM X 6CM DELTAPAQ (CDF10020630/UNK LOT) AND THE 1.5MM X 3CM DELTAPLUSH 10 (CPL10015330/UNK LOT) AND DECIDED TO REMOVE THEM FROM THE PATIENT; HOWEVER, WHILE RE-SHEATHING THE COILS, THE INTRODUCERS FAILED TO BE RE-ZIPPED. THE COILS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. EVALUATION OF THE RETURNED 1.5MM X 3CM DELTAPLUSH 10 REVEALED EMBOLIC COIL DAMAGE/SEPARATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242264 ↗
• MalfunctionJan 10, 2019Material Twisted/Bent; Material Twisted/Bent

  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 8233731 ↗
• MalfunctionApr 3, 2018Material Separation; Stretched; Material Separation; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN UNKNOWN TARGET SITE, THE DELTAPL CERE COIL 10 SYS 1.5 X 3 (CPL10015330 / C41244) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER (UNKNOWN BRAND). THE COIL WAS WITHDRAWN AND A NEW COIL WAS USED TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THE COIL DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE CONCOMITANT DEVICES USED WITH THE DELTAPL CERE DID NOT KINK OR BEND AT ANY TIME. WHEN THE COIL WAS REMOVED FROM THE PATIENT, THERE WERE NO DAMAGES ON ANY PART OF THE DEVICE. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WAS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393885 ↗
• MalfunctionMar 27, 2018Kinked; Material Separation; Kinked; Material Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, ABNORMAL FRICTION WAS ENCOUNTERED BETWEEN THE COIL DELIVERY WIRE AND THE COIL INTRODUCER OF A 3MM X 6CM DELTAPAQ 10 CERECYTE THERMO-MECHANICAL COIL (CDF10030630/LOT UNKNOWN) AND A 1.5MM X 3CM DELTAPLUSH10 CERECYTE THERMO-MECHANICAL COIL (CPL10015330/LOT UNKNOWN). IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372772 ↗
• MalfunctionJan 11, 2018Positioning Failure; Kinked; Positioning Failure; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE 1.5MM X 3CM DELTAPLUSH THERMO-MECHANICAL COIL (B)(4) COULD NOT BE DETACHED DESPITE MULTIPLE ATTEMPTS, MANIPULATION, AND EXCHANGE OF CONTROL CABLES AND DETACHMENT CONTROL SYSTEMS. THE COIL WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND REPLACED. THE ISSUE RESULTED IN ¿INEFFECTIVE MANIPULATION¿ IN THE ANEURYSM. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. THE DEVICE HAD NOT BEEN REPROCESSED AND REUSED ON A PATIENT. THE USER WAS TRAINED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7182289 ↗
• MalfunctionMay 22, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COIL EMBOLIZATION PROCEDURE FOR A TYPE II ENDOLEAK AT THE IMA LUMBAR, RESISTANCE WAS ENCOUNTERED WHEN THE C-PRESIDIO10(PC4100730-30/C37720) AND C-DELTAPLUSH(CPL100153-30/C27716) COILS SEEMED TO BE OUT OF THE MICROCATHETER AND COULD NOT BE ADVANCED. THE SHEATH WAS INSERTED FROM THE FEMORAL ARTERY. AN APPROACH WAS MADE TO SMA WITH A GUIDING CATHETER AND IT WAS ATTEMPTED TO PLUG THE COLLATERAL EXTEND TO IMA. TWO MICROCATHETERS WERE USED FOR THIS PROCEDURE. THE VESSEL WAS HEAVILY TORTUOUS; THEREFORE, IT WAS DIFFICULT TO APPROACH BUT THE TELLUS MICROCATHETER WAS SUCCESSFULLY PLACED AND EMBOLIZATION WAS STARTED. THE C-PRESIDIO10 (COMPLAINT PRODUCT 1) USED FOR THE 1ST COIL. THE COIL WAS INSERTED INTO THE HUB AND IT WAS ADVANCED AFTER IT WAS PEELED AWAY. WHEN THE COIL SEEMED TO BE OUT OF THE TELLUS MICROCATHETER, STRONG RESISTANCE WAS FELT AND IT COULD NOT BE ADVANCED. THE COIL WAS REPLACED WITH ANOTHER PRESIDIO10 AND IT WAS SUCCESSFULLY DETACHED. AN APPROACH WAS CONTINUED TO BE MADE TO THE LUMBAR ARTERY WITH THE SAME SYSTEM. THE TELLUS MICROCATHETER WAS CHANGED TO A CARAVEL MICROCATHETER AND A DELTAPLUSH (COMPLAINT PRODUCT 2) WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6582997 ↗
• MalfunctionMay 11, 2017Kinked; Deformation Due to Compressive Stress; Kinked; Deformation Due to Compressive Stress

  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 6559752 ↗
• MalfunctionMar 23, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A DELTAPLUSH CERECYTE COIL 1.5MM X 3CM FAILED TO RESHEATH. THE COIL WAS THE FOURTH COIL BEING USED FOR THE PROCEDURE. THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT, HOWEVER THE COIL INTRODUCER FAILED TO RE-SHEATH. THE PHYSICIAN USED A SAME LIKE PRODUCT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE EVENTS OR PATIENT INJURIES REPORTED DUE TO THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6428217 ↗
• MalfunctionMar 9, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR A TYPE 2 ENDOLEAK, THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AND THE DELTAPLUSH COIL (CPL10015330/ S11306) COULD NOT BE USED. THE SL-10 MICROCATHETER WAS APPROACHED TO THE FEEDER ARTERY. THE DELTAPLUSH WAS CONNECTED TO THE CABLE, BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. IT WAS UNKNOWN IF A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THERE WAS NO PATIENT INJURY / COMPLICATION REPORTED. 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 VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390816 ↗
• MalfunctionFeb 16, 2017Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAPLUSH COIL INTRODUCER (CPL10015330/ S10763) FAILED TO RE-ZIP, AND DURING PRODUCT ANALYSIS IT WAS DETERMINED THAT THE COIL HAD DAMAGE THAT MAY NOT HAVE BEEN SEEN BY THE CUSTOMER. THIS WAS THE SECOND COIL USED. THE PHYSICIAN DID NOT LIKE THE SHAPE OF 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 TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE HAD BEEN NO DIFFICULTY DURING UNSHEATHING THE DEVICE, AND EXCESSIVE FORCE HAD NOT BEEN APPLIED. THE COIL DID NOT APPEAR DAMAGED (I.E. KINKED, STRETCHED, SEPARATED, DETACHED). THERE WERE NO POTENTIAL ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6336036 ↗
• MalfunctionDec 2, 2016Material Separation; Failure to Advance; Material Separation; Failure to Advance

  THE CONTACT FROM THE FACILITY REPORTED THAT COIL (CPL10015330/C39056) DIDN'T ADVANCE INTO THE RHV DUE TO FRICTION BETWEEN DELIVERY WIRE AND COIL SHEATH. THE SURGEON FELT SEVERE FRICTION, SO USED NEW COIL. PROCEDURE FINISHED NORMALLY WITHOUT ANY OTHER DELAY OR COMPLICATIONS. AT THE TIME OF INITIAL CONTACT THE DEVICE WAS AVAILABLE FOR RETURN. DURING PRODUCT ANALYSIS IT WAS DISCOVERED THAT THE EMBOLIC COIL WAS SEPARATED NEAR THE PROXIMAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6142967 ↗
• MalfunctionNov 9, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A CEREBRAL ANEURYSM AT THE ANTERIOR CEREBRAL ARTERY A DELTAPLUSH COIL (CPL10015330/C33384) FAILED TO DETACH. AN APPROACH WAS MADE FROM FEMORAL ARTERY AND A GUIDING CATHETER (8FR) WAS TAKEN TO THE COMMON CAROTID ARTERY. A MICRO CATHETER WAS THEN INSERTED INTO THE GUIDING CATHETER AND IT WAS ACCESSED TO THE LESION. THE C-DELTAPLUSH (COMPLAINT PRODUCT) WAS USED AS 7TH COIL. HOWEVER THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE DURING THE PRE-DETACHMENT ELECTRICAL CHECK ALTHOUGH THE PRE-DETACHMENT ELECTRICAL CHECK WAS DONE WITHOUT ANY PROBLEM WITH ANOTHER COIL (DELTAPLUSH) BEFORE USING THE COMPLAINT COIL. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (SAME SIZE DELTAPLUSH, UNKNOWN LOT#). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY WITH 9 COILS. THERE WERE ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE PATIENT WAS MALE BUT HIS AGE WAS UNKNOWN. THE LEVEL OF VESSEL TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. 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 T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6089394 ↗
• MalfunctionOct 27, 2016Physical Resistance; Deformation Due to Compressive Stress; Physical Resistance; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY ANEURYSM, IT WAS DIFFICULT TO INSERT THE DELTAPLUSH (CPL10015330/C33384) INTO THE SL-10 MICROCATHETER DUE TO RESISTANCE. THE COIL WAS REPLACED WITH ANOTHER COIL (DIFFERENT SIZE). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. 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 VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PATIENT'S INFORMATION WAS UNKNOWN. THE PATIENT'S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE. PRODUCT ANALYSIS REVEALED THAT THE COIL COULD NOT BE ADVANCED OUT TO THE INTRODUCER SHEATH, AND THE ACTUAL COIL WAS BUCKLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6060357 ↗
• MalfunctionOct 12, 2016Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE COIL EMBOLIZATION FOR EPISTAXIS AT THE EXTERNAL CAROTID ARTERY A DELTAPLUSH COIL (CPL10015330/C40839) WAS REPORTED TO BE DAMAGED. THE PATIENT WAS MALE OF UNKNOWN AGE WHOSE VESSELS WERE MILDLY TORTUROUS AND NOT CALCIFIED. A GUIDING CATHETER WAS PLACED (COMPETITOR'S DEVICE) AND THEN THE MICRO CATHETER (COMPETITOR'S DEVICE) WAS ADVANCED TO THE RIGHT ASCENDING PHARYNGEAL ARTERY TO THE MAXILLARY ARTERY USING A GUIDEWIRE. THE MICROCATHETER WAS THEN ADVANCED FURTHER TO THE LEFT ASCENDING PHARYNGEAL ARTERY AND "OTHER ARTERY" WHICH SEEMED TO BE RELATED TO THE EPISTAXIS. THE COMPLAINT DELTAPLUSH COIL WAS THE 16TH COIL BEING USED; HOWEVER THE WIRE PART WAS EXPOSED FROM THE INTRODUCER SHEATH DURING INSERTION, AND COULD NOT BE INSERTED AT ALL. THE COIL WAS REPLACED WITH ANOTHER COIL. 33 DETACHABLE COILS WERE USED FOR THIS PROCEDURE IN TOTAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIME. N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6023667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083646. One submission often covers many models, so check the product and lot details in each record.

• Z-0845-2011 · Oct 21, 2010 · Terminated
  Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control B