DELTAFILL DLF181040Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886704077114), received between Oct 25, 2017 and May 12, 2026 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Stretched; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS AN ENDOVASCULAR EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, THE EMBOLIZATION OF SPLENIC ARTERY ANEURYSM WAS PERFORMED USING A 4FR ANGIOGRAPHIC CATHETER AND LIGHTHOUSE MICROCATHETER (MC). AFTER FRAMING WITH A TARGET XXL (STRYKER), THE USER INITIATED FILLING USING DLF COILS. AFTER USING ONE 18MM AND ONE 12MM COIL, THE USER ATTEMPTED TO PLACE A DELTAFILL18 10MM X 40CM (PRODUCT CODE: DLF181040, LOT NUMBER: 0282601S). THE PHYSICIAN NOTED STIFFNESS WHEN PLACING THE COIL COMPARED WITH USUAL. CONSIDERING THE POSSIBILITY THAT THE MICROCATHETER POSITION WAS NOT PROPER, RE-SHEATHED THE COIL AND ADJUSTED THE MICROCATHETER POSITION TWICE. WHILE ADVANCING AND RE-SHEATHING THE COIL THEREAFTER, IT UNRAVELED. THE DELTAFILL COIL WAS RETRIEVED WITH THE MICROCATHETER AND THE WHOLE SYSTEM WAS CHANGED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR¿S COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149806 ↗
• MalfunctionNov 13, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A COIL EMBOLIZATION OF INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERY. THE EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERY WAS PERFORMED WITH THE SYSTEM CONSISTING OF A 4FR ANGIOGRAPHIC CATHETER AND COILING SUPPORT (MEDICOS HIRATA). DURING EMBOLIZATION OF THE LUMBAR ARTERY, ATTEMPTED TO PLACE THE DELTAFILL18 10MM X 40CM COIL (DLF181040, 2232527S). THE POWER INDICATOR LIT BUT COULD NOT DETACH THE COIL. THE DELTAFILL18 COIL WAS RETRIEVED AND REPLACED WITH A COIL OF THE SAME SPECIFICATION, WHICH WAS PLACED WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542915 ↗
• MalfunctionOct 29, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE PROCEDURE WAS A COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY. THE EMBOLIZATION OF THE INTERNAL ILIAC ARTERY BRANCHES AND MAIN TRUNK WAS PERFORMED WITH THE ANGIOGRAPHIC CATHETER AND PROWLER SELECT PLUS MICROCATHETER (MC). THE DELTAFILL18 3MM X 12CM (DLF180312, 31178109) WAS USED FOR THE FIRST BRANCH. THE COIL GOT STUCK IN THE MICROCATHETER, AND RESISTANCE WAS FELT AT THE SAME POSITION. THEREFORE, THE DELTAFILL 18 COIL (DLF180312) WAS RETRIEVED AND REPLACED WITH A DIFFERENT COIL OF THE SAME SPECIFICATIONS. SINCE THE REPLACED COIL WAS USED WITHOUT ANY ISSUES, THE DELTAFILL 18 COIL (DLF180312) WAS DISCARDED. A 12MM DELTAFILL WAS USED FOR THE FIRST COIL FOR THE MAIN TRUNK, AND A DELTAFILL18 10MM X 40CM COIL (DLF181040, 2232527S) WAS USED AS THE SECOND COIL. BUT THE SECOND COIL DID NOT FIT WELL, SO IT WAS ATTEMPTED TO BE RETRIEVED. DURING RETRIEVAL, THE COIL DETACHED INSIDE THE MICROCATHETER. WHEN THE MICROCATHETER WAS RETRIEVED ONCE, THE DELTAFILL 18 COIL (DLF181040) COULD BE RETRIEVED WITH THE MICROCATHETER AS A SYSTEM. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING ONLY J&J COILS. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415551 ↗
• MalfunctionAug 21, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A SUBCLAVIAN ARTERY ENDOLEAK DURING A THORACIC ENDOVASCULAR AORTIC ANEURYSM REPAIR (TEVAR) PROCEDURE, THE EMBOLIZATION WAS PERFORMED BY ¿PLUG-IN COIL TECHNIQUE,¿ A PLUG WAS PLACED INTO THE SUBCLAVIAN ARTERY, AND WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE COMPLAINT COIL, A 10MM X 40CM DELTAFILL 18 (DLF181040 / 30915613) USING MICROCATHETER (COILING SUPPORT) BY PLUG-IN COIL, THERE WAS RESISTANCE IN THE MICROCATHETER; IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED, THE COIL WAS RETRIEVED. THE COIL APPEARED TO HAVE UNRAVELED. THE COIL ITSELF COULD BE REMOVED ENTIRELY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING FOUR OTHER 10MM X 40CM DELTAFILL 18 COILS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 21-AUG-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFORMATION INDICATED THAT AN ADEQUATE, CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE MICROCATHETER USED WAS A ¿COILING SUPPORT.¿ THE BRAND WAS NOT PROVIDED. THERE WAS RESISTANCE INSIDE THE MICROCATHETER AND THE COIL WAS WITHDRAWN BEFORE IT REACHED THE TARGET SITE. THE INFORMATION INDICATED THAT THE COIL WAS NOT REPOSITIONED BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17588365 ↗
• MalfunctionAug 7, 2023Device Difficult to Setup or Prepare; Positioning Problem; Premature Separation; Device Difficult to Setup or Prepare; Positioning Problem; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A VISCERAL ARTERY ANEURYSM, A MICROCATHETER WAS INSERTED, COMPETITORS¿ COILS WERE ALREADY PLACED IN THE ANEURYSM. THEN, A DELTAFILL18 10MM X 40CM (DLF181040, 30915611) PREMATURELY DETACHED IN THE MICROCATHETER DURING RETRIEVAL, SO THE COIL AND MICROCATHETER WERE PULLED OUT TOGETHER. THE MICROCATHETER WAS INSERTED AGAIN AND ANOTHER NEW COIL WAS PLACED. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO NECK REMODELING WAS UTILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469396 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A PERSONAL INTERACTION THAT A PATIENT OF UNKNOWN AGE AND SEX (NO DEMOGRAPHIC INFORMATION WAS PROVIDED) UNDERWENT AN ENDOVASCULAR COIL EMBOLIZATION OF A PULMONARY ARTERIOVENOUS MALFORMATION USING A DELTAFILL18 10MM X 40CM (DLF181040/ UNKNOWN LOT) COIL. IT WAS STATED THE FOLLOWING: ¿THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS NOT KNOWN EXACTLY WHEN BUT AFTER THE PROCEDURE, RECANALIZATION WAS IDENTIFIED.¿ IT IS UNKNOWN OF ADDITIONAL INTERVENTION WAS NECESSARY AS THIS INFORMATION WAS COLLECTED FROM A CONFERENCE PRESENTATION. THE PHYSICIAN COMMENTED THAT THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE RECANALIZATION AND THE COIL AND THAT THIS WAS A WAS NON-SERIOUS EVENT. IT IS UNKNOWN IF CONTINUOUS FLUSH WAS PERFORMED OR IF THERE WAS ANY IMPACT TO THE PATIENT. OTHER CONCOMITANT DEVICES ARE PRESENTLY UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 17037602 ↗
• MalfunctionSep 8, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, THIS WAS A STENT-GRAFT COIL EMBOLIZATION. A 10MM X 40CM DELTAFILL COIL (DLF181040, 30603563) WAS USED AT DEBRANCH. A PROWLER SELECT PLUS 150/5CM 45 TIP (606S255FX, 30674743) MICROCATHETER (MC) WAS ADVANCED TO THE TARGET SITE. WHEN THE 10MM X 40CM DELTAFILL WAS USED, THE COIL BECAME STUCK IN THE MICROCATHETER AND WAS NOT ABLE TO BE DELIVERED. AS THE COIL WAS NOT ABLE TO MOVE INSIDE THE MICROCATHETER, THE COIL WAS REMOVED WITH THE CONCOMITANT MICROCATHETER FROM THE PATIENT¿S BODY. A NEW MICROCATHETER (PROWLER SELECT PLUS) WAS USED AND ADVANCED TO THE TARGET SITE. ANOTHER COIL OF THE SAME CATALOG NUMBER WAS EMBOLIZED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS UNKNOWN. THE LESION IS UNKNOWN. BASED ON THE ANALYSIS OF THE DELTAFILL COIL RECEIVED, IT WAS NOTED THAT THE COIL WAS ENTANGLED, SEVERELY STRETCHED AND BROKEN IN TWO SEPARATED FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379182 ↗
• MalfunctionJul 28, 2022Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE SUBCLAVIAN ARTERY, A DELTAFILL COIL WAS IMPLANTED BETWEEN A STENT GRAFT AND A PLUG UNDER THE SUBCLAVIAN. THEN A 10MM X 40CM DELTAFILL18 COIL (DLF181040, 30710664) WAS USED AS THE SECOND COIL, BUT IT GOT STUCK IN THE INTRODUCER SHEATH AND DELIVERY WAS NOT ABLE TO PROGRESS. THE PHYSICIAN CONFIRMED THAT INTRODUCER SHEATH WAS TWISTED AND CRUSHED. THE COIL DELIVERY SYSTEM WAS REMOVED AS PER USUAL. AFTER THAT, THE SAME SIZE OF THE SAME COIL AS THE COMPLAINT PRODUCT WAS USED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE INTRODUCER SHEATH WAS TWISTED AND CRUSHED. NO REPORT THAT THE DEVICE APPEARS DAMAGED. THE INTRODUCER WAS FLUSHED UNTIL THE 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 DEVICE ADVANCEMENT. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122351 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA (B)(6) STUDY, AN (B)(6) MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF HYPERTENSION, DYSLIPIDEMIA, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 50MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED TYPE II TARGET VESSEL ENDOLEAK 237 DAYS AFTER THE PROCEDURE. THE STUDY PROCEDURE WAS INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS A GORE EXCLUDER AAA-ENDOPROSTHESIS. A TOTAL OF THREE SPECTRA DELTAFILL 18 COILS WERE IMPLANTED AT THE INTERNAL ILIAC ARTERY (IIA). FLUOROSCOPY TIME WAS 97.6 MINUTES. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS HOSPITALIZED NINE DAYS. THE COMPLAINT COIL REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 13203849 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, A (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, DIABETES, CORONARY ARTERY DISEASE, CEREBROVASCULAR DISEASE, DYSLIPIDEMIA, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 55MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED A VESSEL DISSECTION OR PERFORATION DURING THE PROCEDURE.THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS A GORE EXCLUDER AAA-ENDOPROSTHESIS. A TOTAL OF FOUR SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE INTERNAL ILIAC ARTERY (IIA): ONE 20MM X 60CM DELTAFILL18 (DLF182060 / LOT# UNKNOWN), ONE 22MM X 60CM DELTAFILL18 (DLF182260 / LOT# UNKNOWN), ONE 18MM X 55CM DELTAFILL18 (DLF181855 / LOT# UNKNOWN), AND ONE 10MM X 40CM DELTAFILL18 (DLF181040 / LOT# UNKNOWN). FLUOROSCOPY TIME WAS 57 MINUTES. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COILS ARE NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 13112374 ↗
• MalfunctionMay 13, 2021Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR PRE-STENTGRAFT AT THE INTERNAL ILIAC ARTERY, A DELTAFILL18 10MM X 40CM COIL (DLF181040, L15924) WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE COIL EMBOLIZATION WAS STARTED. AFTER, A LEONISMOVER MICROCATHETER (MC) WAS APPROACHED TO THE TARGET LESION, THE DELTAFILL18 WAS INSERTED TO THE MICROCATHETER AS THE FIRST COIL, BUT THERE WAS A RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MC. THE RESISTANCE WAS FELT INSIDE THE MC. THE DELIVERY WIRE ALSO KINKED. THEREFORE, THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER ONE. AFTER THAT, THE PROCEDURE WAS COMPLETED SAFELY. CONTINUOUS FLUSH ON THE MICROCATHETER WAS NOT MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION 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 11821355 ↗
• MalfunctionMay 11, 2021Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE FOR A PRE-STENT GRAFT, THE 10MM X 40CM DELTAFILL 18 COIL (DLF181040 / 30393155) WAS USED AS THE SECOND COIL. IT WAS REPORTED THAT THE COIL PART BECAME BENT IN A CONCOMITANT MICROCATHETER AND AS A RESULT, COULD NOT BE DELIVERED. IT WAS REPLACED WITH ANOTHER 10MM X 40CM DELTAFILL 18 COIL AND THE REPLACEMENT COIL WAS IMPLANTED WITHOUT ANY PROBLEMS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806803 ↗
• MalfunctionApr 12, 2021Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE AT THE INTERNAL ILIAC ARTERY, THE 10MM X 40CM DELTAFILL 18 COIL (DLF181040 / 30478863) WAS BEING DELIVERED BUT IT BECAME SLIGHTLY KINKED. THE KINK RESULTED IN AN INTENSE RESISTANCE BETWEEN THE COIL AND THE CONCOMITANT CARNELIAN® MARVEL® (TOKAI MEDICAL PRODUCTS). THE COMPLAINT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649820 ↗
• MalfunctionJan 26, 2021Break; Device Difficult to Setup or Prepare; Difficult to Advance; Break; Device Difficult to Setup or Prepare; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOLEAK AFTER A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVER) PROCEDURE, A 10MM X 40CM DELTAFILL18 (DLF181040, L17037) COIL WAS USED AS THE FOURTH COIL BUT THERE WAS AN INTENSIVE RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND A CONCOMITANT MICROCATHETER (CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS). THE COMPLAINT COIL WAS ATTEMPTED TO BE RE-SHEATHED BUT THE SHEATH GOT DAMAGED AND IT WAS NOT ABLE TO BE RE-SHEATHED. THIS PROCEDURE USED EIGHT OTHER COILS BUT ONLY THE COMPLAINT COIL HAD THE INTENSIVE RESISTANCE. NO PATIENT INJURY WAS REPORTED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE DEVICE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND SLIGHTLY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229655 ↗
• InjuryDec 29, 2020Unraveled Material; Activation Problem; Unraveled Material; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING A CELIAC ARTERY ANEURYSM, THE 10MM X 40CM DELTAFILL 18 COIL (DLF181040 / 30393155) WAS EMBOLIZED BUT HALF THE COIL WAS NOT ABLE TO ADVANCE THROUGH THE CONCOMITANT CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL). A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL AND THE DELIVERY WIRE WAS RETRACTED, BUT THE COIL BECAME UNRAVELED. THE COIL HAD TO BE REMOVED USING A MICRO SNARE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE EVENT. THE EVENT ALSO DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURE DELAY. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091070 ↗
• MalfunctionSep 10, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT-GRAFT COIL EMBOLIZATION PROCEDURE, THE SHEATH INTRODUCER OF THE 10MM X 40CM DELTAFILL 18 COIL (DLF181040 / K10232) WAS PRESSED AGAINST THE HUB OF THE CONCOMITANT MICROCATHETER THAT WAS BEING USED FOR COILING SUPPORT, THE COIL WAS INSERTED INTO THE MICROCATHETER BUT PART OF THE SHEATH GOT SPLIT AND THE COIL WAS EXPOSED FROM THE SPLIT PART OF THE SHEATH. ANOTHER 10MM X 40CM DELTAFILL 18 COIL FROM LOT K10147 WAS CHOSEN AS A REPLACEMENT BUT THE SAME ISSUE WITH THE SPLIT SHEATH OCCURRED. A THIRD COIL WAS CHOSEN, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE (DLF181040 / K10232) WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS 9/8/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10516518 ↗
• MalfunctionAug 31, 2020Premature Separation; Premature Separation

  AS REPORTED BY THE FILED, DURING A COIL EMBOLIZATION, THE PHYSICIAN SET THE COIL SHEATH OF A 10MM X 40CM DELTAFILL18 (DLF181040, L14584) IN THE HUB OF A CONCOMITANT MICROCATHETER (EXCELSIOR1018, STRYKER). IT WAS SET BY CONNECTING THE Y-SHAPED CONNECTOR DURING HEPARIN CONTINUOUS FLUSH. WHEN THE PHYSICIAN TRIED TO INSERT THE COMPLAINT COIL INTO THE MICROCATHETER BY PUSHING THE DELIVERY WIRE, THE HUB AND THE SHEATH WERE NOT CRIMPED ENOUGH, AND THE COMPLAINT COIL CAME OUT ABOUT 10 MM FROM THE GAP. THEREFORE, HE REMOVED THE SHEATH FROM THE HUB AND PULLED THE DELIVERY WIRE TO WITHDRAW THE COMPLAINT COIL INSIDE THE SHEATH. HOWEVER, THE COMPLAINT COIL COULD NOT BE PULLED. HE REMOVED THE DELTAFILL18 COMPLAINT COIL FROM THE SHEATH BY PUSHING THE WIRE AND NOTICED THAT THE CONNECTION PART WAS DISCONNECTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RHV WAS NOT TIGHTENED AROUND THE INTRODUCER SUFFICIENTLY. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. THERE WAS NO SIGNIFICANT PROCEDURAL DELAY DUE TO THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471596 ↗
• MalfunctionAug 25, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT EMBOLIZATION AT THE INTERNAL ILIAC ARTERY, THE 10MM X 40CM DELTAFILL 18 COIL (DLF181040 / L16726) WAS INSERTED INTO THE PATIENT AND DELIVERED TO THE LESION. THE ENPOWER CONTROL CABLE (ECB00018200 / 30367116) WAS USED BUT IT WAS NOT ABLE TO DETACH THE COIL WHEN THE DETACHMENT BUTTON WAS PRESSED SEVERAL TIMES. THE ENPOWER CONTROL CABLE WAS REPLACED BUT THE SAME ISSUE CONTINUED. THE COIL WAS REPLACED WITH ANOTHER 10MM X 40CM DELTAFILL 18 COIL FROM LOT L14327, BUT THIS COIL ENCOUNTERED RESISTANCE WITH THE CONCOMITANT LEONIS MOVA MICROCATHETER (SUMIMOTO BAKELITE) AND COULD NOT BE ADVANCED. A COMPETITOR COIL WAS CHOSEN AS THE REPLACEMENT AND WAS IMPLANTED WITHOUT ANY ISSUES. THE PROCEDURE WAS RESUMED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452053 ↗
• MalfunctionAug 12, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A PRE-SG COIL EMBOLIZATION OF THE CHEST FOR PREVENTION OF TYPE 2 EL. A 10MM X 40CM DELTAFILL18 COIL (DLF181040, L16221) WAS BEING USED AS THE FIRST COIL. THE PHYSICIAN PRESSED THE SHEATH INTRODUCER AGAINST THE HUB OF A CONCOMITANT MICROCATHETER (COILING SUPPORT) AND INSERTED THE COIL INTO THE MICROCATHETER MC). IT WAS ATTEMPTED TO BE DETACHED WITH AN ENPOWER CONTROL CABLE (ECB00018200, 30367116). THE DETACHMENT BUTTON WAS PRESSED BUT IT WAS NOT ABLE TO BE DETACHED. THE BUTTON WAS PRESSED TWICE BUT THE SAME ISSUE CONTINUED. THE PHYSICIAN CHANGED THE DETACHABLE CONTROL BOX 2(DCB) (USED ONLY IN (B)(6)) BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS USED AS THE SECOND COIL BUT IT WAS NOT ABLE TO BE DETACHED SO, IT WAS REMOVED FROM THE PATIENT. THE COMPLAINT CABLE WAS REPLACED WITH ANOTHER CABLE AND THE COIL WAS DETACHED. A SAME SIZED COIL WAS USED AS THE THIRD COIL AND IT WAS DETACHED. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THERE WAS NO PROLONGATION OF THE PROCEDURE DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396372 ↗
• MalfunctionJun 2, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ABDOMINAL VEIN ANEURYSM, A 10MM X 40CM DELTAFILL 18 COIL (DLF181040, L14584) WAS USED, BUT IT WAS NOT ABLE TO WINDED AS INTENDED. THE PHYSICIAN ATTEMPTED TO RE-WINDED THE COIL, HOWEVER, THE CONCOMITANT MICROCATHETER GOT KICKED BACK. THE COMPLAINT COIL WAS ATTEMPTED TO BE RE-SHEATHED FOR REPOSITION, BUT THE SHEATH INTRODUCER GOT DAMAGED AND IT WAS NOT ABLE TO BE RE-SHEATHED. THEREFORE, THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY AND THE PROCEDURE COMPLETED BY USING ANOTHER COIL. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108666 ↗
• MalfunctionSep 19, 2019Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, THERE WAS RESISTANCE FELT BETWEEN THE FOLLOWING COILS: 12MM X 40CM MICRUSFRAME 18 (MFR181240, L14606), 12MM X 40CM MICRUSFRAME 18 (MFR181240, L14780) AND A 10MM X 40CM DELTAFILL 18 (DLF181040, L14455) AND A PROWLER SELECT MICROCATHETER (MC) DURING INSERTION, INSIDE THE MICROCATHETER. THE RESISTANCE WAS FELT WITH THE SAME MC. THE BLOOD FLOW WAS VERIFIED BY ANGIOGRAPHY AND THE COMPLAINT COILS WERE NOT INTERRUPTED BY THE FLOW. THEREFORE, THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER COIL AND THE SAME MC WAS USED WITHOUT ANY PROBLEMS. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. PRELIMINARY PHOTOS FROM 3 MICROCOIL SYSTEMS AND A PROWLER SELECT DEVICE WERE RECEIVED ON (B)(4) 2019. BASED ON THE PRELIMINARY PHOTO OBSERVATION, COIL (LOT# L14455) WAS STRETCHED AND ENTANGLED, COIL (LOT# L14606 WAS STRETCHED, AND COIL (LOT# L14780 WAS STRETCHED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE COILS WERE UNRAVELED AND TANGLED WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087015 ↗
• MalfunctionJul 18, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A SUBARACHNOID HEMORRHAGE (SAH)COIL EMBOLIZATION OF AN ANEURYSM AT THE IC-TOP, THE PHYSICIAN ATTEMPTED TO INSERT A 10MM X 40CM DELTAFILL18 COIL (DLF181040, S12385) TO THE PATIENT¿S BODY, THE COIL PROTRUDED FROM THE INTRODUCER SHEATH AND THE DELIVERY WIRE COULD NOT ADVANCE. FOURTEEN NON-CERENOVUS COILS WERE IMPLANTED IN THE LESION. THERE WAS NO PATIENT INJURY REPORTED. THE REPORTED EVENT DID NOT RESULT IN A PROCEDURAL DELAY. INITIALLY, AS THE A1 WAS INVOLVED, THE FLOW FROM THE OPPOSITE SIDE WAS CONFIRMED BY A BALLOON OCCLUSION TEST. THEREFORE, A COIL EMBOLIZATION STARTED. THE PHYSICIAN NECK PLASTIED WITH A BALLOON CATHETER AND APPROACHED WITH A MICROCATHETER (SL10) WHICH HAD BEEN STEAM-SHAPED. FIVE COILS (16X50 PRIMEFRAME, 16X50 PRIMEFRAME, 14X45 DELTAFILL18, 14X45 DELTAFILL18 AND 12X42 DELTAFILL18) WERE IMPLANTED IN THE LESION. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE DEVICE WAS STORED AND HANDLED PER INSTRUCTIONS FOR USE (IFU). THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT APPLY EXCESSIVE FORCE DURING UNSHEATHING OR RE-SHEATHING. THERE WAS NO DAMAGE FOUND ON ANY PART OF THE ACT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803830 ↗
• MalfunctionOct 9, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PRE-STENT GRAFT COIL EMBOLIZATION OF THE LEFT EXTERNAL ILIAC ARTERY, THE 10MM X 40CM DELTAFILL18 COIL (DLF181040/S11950) THERMO-MECHANICAL COIL WAS SELECTED FOR USE AS THE THIRD COIL, BUT SOME RESISTANCE WAS ENCOUNTERED BETWEEN THE COIL AND THE INTRODUCER. THE DEVICE WAS FLUSHED BUT THE COIL COULD NOT BE ADVANCED IN THE INTRODUCER. THE DELIVERY WIRE THEN BECAME EXPOSED. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME. A RADIFOCUS (TERUMO) GUIDEWIRE, PROWLER SELECT PLUS 45° MICROCATHETER, TERUMO SHEATH INTRODUCER, AND DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. EVALUATION OF THE RETURNED PRODUCT REVEALED EMBOLIC COIL DAMAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947044 ↗
• MalfunctionAug 27, 2018Separation Failure; Material Deformation; Separation Failure; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PRE-ENDOVASCULAR ANEURYSM REPAIR (EVAR) COIL EMBOLIZATION OF A LEFT INTERNAL ILIAC ARTERY ANEURYSM, THE 10 MM X 40 CM DELTAFILL18 (DLF181040/L11445) THERMO-MECHANICAL COIL WAS USED AS THE THIRD COIL IN THE CASE, BUT THE ENPOWER DETACHMENT CONTROL BOX POWER LAMP DID NOT ILLUMINATE. THE ENPOWER CONTROL CABLE (ECB000182-00/S14342) WAS REPLACED, BUT THE ISSUE CONTINUED. THEREFORE, THE DELTAFILL COIL WAS REMOVED FROM THE PATIENT SUCCESSFULLY AND REPLACED WITH A COIL FROM THE SAME CATALOG NUMBER. NINE SPECTRA COILS WERE THEN PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. THE PRODUCTS WERE HANDLED AND PREPPED AS PER THE IFU. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A TERUMO SHEATH INTRODUCER, A RADIFOCUS (TERUMO) GUIDEWIRE, A PROGRETE¿ (TERUMO)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818427 ↗
• MalfunctionMay 23, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, WHEN THE DELTAFILL 18 10 MM X 40 CM (DLF181040 / S13437) WAS INSERTED INTO THE MICROCATHETER, A PROWLER SELECT PLUS (606S255X / 17738047), THERE WAS STRONG RESISTANCE FELT AT THE TIP OF THE MICROCATHETER, AS A RESULT, THE COIL COULD NOT BE ADVANCED. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL BY WITHDRAWING IT FROM THE MICROCATHETER. THE COIL BECAME UNRAVELED IN THE MICROCATHETER. THE COIL AND THE MICROCATHETER WERE BOTH REMOVED. THE COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR 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. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT; NO UNINTENDED DETACHMENT IN THE VESSEL OR IN THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7537814 ↗