DELTAFILL DLF182060Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886704077169), received between Jun 28, 2017 and May 19, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A COIL EMBOLIZATION OF INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERY PRIOR TO STENT GRAFT IMPLANTATION TO TREAT ABDOMINAL AORTIC ANEURYSM. AFTER EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY USING J&J COILS, EMBOLIZATION OF THE LUMBAR ARTERY WAS PERFORMED. AN ATTEMPT WAS MADE TO DEPLOY THE A DELTAFILL18 20MM X 60CM COIL (PRODUCT CODE: DLF182060, LOT NUMBER: 3422537S). HOWEVER, DETACHMENT WAS NOT POSSIBLE. THERE WERE NO ISSUES OBSERVED WITH THE CONTROL BOX, INCLUDING INDICATOR LIGHTS. SINCE COIL DETACHMENT HAD BEEN PERFORMED WITHOUT ANY PROBLEMS DURING EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY, THE ISSUE WAS CONSIDERED TO BE RELATED TO THE DELTAFILL18 COIL. THE DELTAFILL18 WAS THEREFORE WITHDRAWN AND REPLACED WITH ANOTHER NEW COIL OF THE SAME SPECIFICATION. THE REPLACEMENT COIL FUNCTIONED WITHOUT ANY PROBLEMS. THERE WAS NO DELAY THAT IMPACTED CLINICAL PRACTICE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE WAS COILINGSUPPORT MICROCATHETER. A 4 FR ANGIOGRAPHIC CATHETER COMBINED WITH COILING SUPPORT (MEDICOS HIRATA) SYSTEM WAS USED. THE DEVICES WERE USED ACCORDING TO THE INSTRUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216199 ↗
• MalfunctionNov 19, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY PRIOR TO ENDOVASCULAR AORTIC REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). AFTER THE 4 FR DIAGNOSTIC CATHETER AND A CARRY LEÓN MICROCATHETER (UTM) APPROACHED THE INTERNAL ILIAC ARTERY, EMBOLIZATION WAS INITIATED. THE FIRST COIL USED WAS A 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S), BUT THE SHEATH SPLIT AT APPROXIMATELY 20-30CM FROM THE TIP DURING THE COIL INSERTION, CAUSING THE COIL TO PROTRUDE MAKING INSERTION DIFFICULT. CONSEQUENTLY, THE COIL WAS REMOVED. IT WAS REPLACED WITH ANOTHER 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S). AFTER TWO ADDITIONAL COILS WERE PLACED, THE 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S) WAS USED AS THE SECOND COIL. IT WAS REPORTED THAT WHEN THE 20MM X 60CM DELTAFILL 18 WAS INSERTED INTO THE MICROCATHETER, THE COIL BECAME ¿TRAPPED AT THE HUB¿ AND COULD NOT ADVANCE. UPON WITHDRAWING THE COIL FROM THE PATIENT¿S ANATOMY, THE COIL AND THE DELIVERY WIRE WERE OBSERVED TO BE DEFORMED. IT WAS THEN REPLACED WITH ANOTHER 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S). THREE (3)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598157 ↗
• MalfunctionAug 7, 2025Fracture; Difficult to Advance; Fracture; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY PRIOR TO STENT GRAFT IMPLANTATION TO TREAT ABDOMINAL AORTIC ANEURYSM. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER APPROACHING THE INTERNAL ILIAC ARTERY WITH THE DIAGNOSTIC CATHETER AND COILING SUPPORT (MEDICOS HIRATA), THE EMBOLIZATION OF THE INTERNAL ILIAC ARTERY WAS INITIATED. A COIL OF THE SAME SPECIFICATION AS THE INVOLVED DELTAFILL COIL WAS PLACED SUCCESSFULLY AS THE FIRST COIL. THE DELTAFILL18 20MM X 60CM COIL (DLF182060, 1982438S) WAS INSERTED INTO THE MICROCATHETER AS THE SECOND COIL, BUT RESISTANCE WAS FELT IN THE MIDDLE OF THE MICROCATHETER, AND THE COIL COULD NOT BE ADVANCED. DESPITE SEVERAL INSERTIONS AND WITHDRAWALS, RESISTANCE WAS FELT AT THE SAME POSITION. WHEN APPLYING A SLIGHT AMOUNT OF EXTRA FORCE, THE DELIVERY WIRE BROKE, SO THE DELTAFILL COIL WAS REMOVED FROM THE PATIENT¿S BODY. NO UNRAVELING OR OTHER ISSUES WERE CONFIRMED. AFTER THAT, THE DELTAFILL COIL WAS REPLACED WITH ANOTHER ONE OF THE SAME SPECIFICATIONS, WHICH COULD BE PLACED WITHOUT PROBLEMS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742154 ↗
• MalfunctionJun 10, 2025Break; Failure to Advance; Material Split, Cut or Torn; Break; Failure to Advance; Material Split, Cut or Torn

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THIS WAS A COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY TO TREAT ABDOMINAL AORTIC ANEURYSM, WHICH WAS PERFORMED PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). AFTER APPROACHED WITH A 4FR DIAGNOSTIC CATHETER AND BREAKTHROUGH MICROCATHETER (BOSTON SCIENTIFIC) TO THE RIGHT INTERNAL ILIAC ARTERY, EMBOLIZATION WAS INITIATED. AFTER ONE J&J COIL WAS PLACED, A DELTAFILL18 20MM X 60CM COIL (DLF182060, 0932403S) WAS ATTEMPTED TO BE USED AS THE SECOND COIL. SINCE THIS DELTAFILL COIL WAS OVERSIZED FOR THE TARGET LESION, IT WAS ATTEMPTED TO BE RETRIEVED TO USE AFTER THE THIRD COIL. DURING RETRIEVAL, THE SHEATH INTRODUCER BROKE AND THE DELTAFILL COIL COULD NOT BE RE-SHEATHED. THEREFORE, THE DELTAFILL COIL WAS REPLACED WITH A J&J COIL WITH A DIFFERENT PRODUCT CODE AND IMPLANTED WITHOUT ANY PROBLEMS. AFTER A TOTAL OF THREE COILS, INCLUDING ONE ADDITIONAL COIL, WERE PLACED, A DELTAFILL18 20MM X 60CM COIL (DLF182060, 0932403S) WAS ATTEMPTED TO BE USED. DURING INSERTION, THIS DELTAFILL COIL GOT STUCK AT THE HUB OF THE MICROCATHETER. THE DELTAFILL COIL WAS DEFORMED, AND STRONG RESISTANCE WAS FELT DURING INSERTION INTO THE MICROCATHETER, SO THE DELTAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177685 ↗
• MalfunctionJun 10, 2025Break; Failure to Advance; Material Split, Cut or Torn; Break; Failure to Advance; Material Split, Cut or Torn

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THIS WAS A COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY TO TREAT ABDOMINAL AORTIC ANEURYSM, WHICH WAS PERFORMED PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). AFTER APPROACHED WITH A 4FR DIAGNOSTIC CATHETER AND BREAKTHROUGH MICROCATHETER (BOSTON SCIENTIFIC) TO THE RIGHT INTERNAL ILIAC ARTERY, EMBOLIZATION WAS INITIATED. AFTER ONE J&J COIL WAS PLACED, A DELTAFILL18 20MM X 60CM COIL (DLF182060, 0932403S) WAS ATTEMPTED TO BE USED AS THE SECOND COIL. SINCE THIS DELTAFILL COIL WAS OVERSIZED FOR THE TARGET LESION, IT WAS ATTEMPTED TO BE RETRIEVED TO USE AFTER THE THIRD COIL. DURING RETRIEVAL, THE SHEATH INTRODUCER BROKE AND THE DELTAFILL COIL COULD NOT BE RE-SHEATHED. THEREFORE, THE DELTAFILL COIL WAS REPLACED WITH A J&J COIL WITH A DIFFERENT PRODUCT CODE AND IMPLANTED WITHOUT ANY PROBLEMS. AFTER A TOTAL OF THREE COILS, INCLUDING ONE ADDITIONAL COIL, WERE PLACED, A DELTAFILL18 20MM X 60CM COIL (DLF182060, 0932403S) WAS ATTEMPTED TO BE USED. DURING INSERTION, THIS DELTAFILL COIL GOT STUCK AT THE HUB OF THE MICROCATHETER. THE DELTAFILL COIL WAS DEFORMED, AND STRONG RESISTANCE WAS FELT DURING INSERTION INTO THE MICROCATHETER, SO THE DELTAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177579 ↗
• MalfunctionMay 30, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE LUMBAR ARTERY TO TREAT AN ABDOMINAL AORTIC ANEURYSM PRIOR TO STENT GRAFT IMPLANTATION, DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). AFTER APPROACHING THE TARGET LESION (LUMBAR ARTERY) WITH THE DIAGNOSTIC CATHETER AND COILING SUPPORT CATHETER (MEDICOS HIRATA), THE 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S) WAS USED AS THE FIRST COIL. DURING IMPLANTATION, THE CABLE WAS CONNECTED AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT IT DID NOT RESPOND. THE COIL WAS THEN RESHEATHED AND REPLACED WITH A NEW 20MM X 60CM DELTAFILL 18 (DLF182060). AFTER CHECKING AND CONFIRMING THE ELECTRICAL CONTINUITY OF THE SECOND (REPLACEMENT) COIL, IT WAS IMPLANTED. THE RESHEATHED FIRST COIL WAS CONNECTED AGAIN AND CHECKED, BUT NO RESPONSE WAS OBSERVED; THE COIL WAS DISCARDED. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 22-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE MICROCATHETER US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115887 ↗
• MalfunctionMar 18, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET LOCATED ON THE INFERIOR MESENTERIC ARTERY (IMA) AND THE LEFT INTERNAL ILIAC ARTERY (IIA) PRIOR TO STENT GRAFT IMPLANTATION, A 5 FR DIAGNOSTIC CATHETER AND A COILING SUPPORT MICROCATHETER WERE USED. COIL EMBOLIZATION OF THE IMA WAS INITIATED. THE FIRST COIL USED WAS A 5MM X 20CM DELTAFILL 18 (DLF180520 / 30910234), BUT THE COIL PROTRUDED FROM THE MIDDLE OF THE INTRODUCER SHEATH DURING ADVANCEMENT. AN UNSUCCESSFUL ATTEMPT TO RETRIEVE THE COIL WAS MADE; THE COIL WAS STUCK AT THE SHEATH AND RE-SHEATHING WAS DIFFICULT. THIS COIL WAS THEN REPLACED AND THE REPLACEMENT COIL WAS SUCCESSFULLY IMPLANTED WITH NO ISSUES. THREE ADDITIONAL CERENOVUS COILS WERE IMPLANTED AND THE COIL EMBOLIZATION FOR THE LEFT IIA WAS INITIATED. THE 20MM X 60CM DELTAFILL 18 (DLF182060 / 31178151) WAS USED AS THE SECOND COIL IN THE IIA. THE ENTIRE COIL WAS CONFIRMED UNDER FLUOROSCOPY TO HAVE EXITED FROM THE MICROCATHETER (UNSPECIFIED BRAND) AND AN ATTEMPT TO DETACH THE COIL WAS MADE, BUT THE COIL COULD NOT DETACH. THE DETACHMENT CONTROL WAS REBOOTED AND ANOTHER UNSUCCESSFUL ATTEMPT TO DETACH THE COIL WAS MADE. THE COIL WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923989 ↗
• MalfunctionFeb 20, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE LEFT INTERNAL ILIAC ARTERY PRIOR TO STENT-GRAFT IMPLANTATION, A 5 FR DIAGNOSTIC CATHETER AND COILING SUPPORT WERE ADVANCED TO THE TARGET LESION., A CERENOVUS FRAMING COIL (FRAME S) WAS IMPLANTED. THE COMPLAINT COIL, A 20MM X 60CM DELTAFILL 18 COIL ((B)(6)) WAS USED AS THE SECOND COIL; IT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS INSERTED INTO THE PATIENT¿S BODY AND THE PHYSICIAN PERFORMED DETACHMENT MANEUVER. THE DELIVERY WIRE WAS PULLED SLOWLY, BUT IT WAS OBSERVED THAT THE COIL WAS ALSO PULLED AND IT HAS NOT BEEN DETACHED. AN ATTEMPT WAS MADE TO DETACH THE COIL, BUT IT COULD NOT DETACH. TWO MORE UNSUCCESSFULLY DETACHMENT ATTEMPTS WERE MADE BEFORE IT WAS REPLACED WITH ANOTHER 20MM X 60CM DELTAFILL 18 COIL ((B)(6)) FROM THE SAME LOT (31178154), AND THE REPLACEMENT COIL WAS IMPLANTED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A TOTAL OF SEVEN (7) CERENOVUS COILS IMPLANTED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 09-FEB-2024, INFORMATION WAS RECEIVED, PER THE INFORMATION, THE MICROCATHETER USED WAS [FOR] ¿COILING SUPPORT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744573 ↗
• MalfunctionSep 29, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FELT STRONG RESISTANCE DURING THE USE OF DELTAFILL18 20MM X 60CM COIL (DLF182060, 30399403). THEREFORE, HE USED ANOTHER SAME-LIKE PRODUCT AND THE PROCEDURE SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE COIL IS NOTED TO BE MECHANICALLY DETACHED FROM THE DELIVERY SYSTEM AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17847208 ↗
• MalfunctionApr 14, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A VISCERAL ARTERY ANEURYSM, THE CERENOVUS SALES REPRESENTATIVE WAS INFORMED THAT THERE WAS DAMAGE ISSUE RELATED TO THE COMPLAINT DEVICE. CONTINUOUS FLUSH WAS MAINTAINED. ON (B)(6) 2023, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT GUIDING CATHETER(S), MICROCATHETER(S), AND MICROWIRE(S) WERE USED TOGETHER. COIL EMBOLIZATION WAS INITIATED AND SEVERAL COMPETITOR COILS WERE IMPLANTED. WHEN THE COMPLAINT COIL, A 20MM X 60CM DELTAFILL 18 (DLF182060 / 30871965) WAS USED, THE ENTIRE COIL WAS INSERTED. WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, IT DID NOT DETACH. A PART OF THE COIL CAME BACK INTO THE MICROCATHETER AND THE PHYSICIAN REMOVED THE COMPLAINT COIL AND THE COMPLAINT CABLE, AN ENPOWER CONTROL CABLE (ECB00018200 / 30975218) AND REPLACED WITH A COMPETITOR COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 04-APR-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: ¿THE PHYSICIAN THOUGHT IT [THE COIL] HAD SUCCESSFULLY DETACHED AND PULLED THE DEVICE POSITIONING UNIT (DPU), BUT IT DID NOT DETACH AND THE COIL GOT STUCK I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747403 ↗
• MalfunctionMay 24, 2022Break; Material Separation; Positioning Problem; Break; Material Separation; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A PRE-SG COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY, A COILING SUPPORT MICROCATHETER (MC) KICKED BACK, A 20MM X 60CM DELTAFILL18 COIL (DLF182060, 30729887) L WAS ATTEMPTED TO BE RE-SHEATHED, BUT THE SHEATH GOT DAMAGED, AND IT WAS NOT ABLE TO BE RE-SHEATHED. IT IS UNKNOWN WHICH PART OF THE SHEATH WAS SEPARATED. THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491473 ↗
• 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 13112377 ↗
• InjuryAug 24, 2021Retraction Problem; Difficult to Advance; Retraction Problem; Difficult to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COIL EMBOLIZATION OF A CAROTID CAVERNOUS FISTULA (CCF) IN A MALE PATIENT, THE PHYSICIAN DELIVERED FOUR DIFFERENT SPECTRA COILS VIA A PROWLER SELECT LP 45° LOT MICROCATHETER (606S155FX/30524499) BUT ENCOUNTERED FRICTION WHILE TRYING TO PLACE A 20MM X 60CM DELTAFILL18 COIL (DLF182060/30483225). THE FRICTION WAS FELT DURING ADVANCEMENT AND RETRACTION OF THE DEVICE. THE PHYSICIAN DECIDED TO RECOVER THE COIL USING A MICROSNARE AND RESCHEDULE THE PROCEDURE FOR TWO DAYS LATER. SIX DIFFERENT COILS WERE THEN IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT IS IN STABLE CONDITION. THE SURGERY WAS PROLONGED 48 MINUTES DUE TO THE EVENT. THE COIL WILL BE RETURNED FOR EVALUATION; HOWEVER, THE PROWLER SELECT LP MICROCATHETER WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359806 ↗
• MalfunctionJun 29, 2021Fracture; Fracture

  AS REPORTED BY THE FIELD, A DELTAFILL18 20MM X 60CM COIL (DLF182060, 30418891) WAS USED BUT IT WAS NOT ABLE TO BE INSERTED INTO AN UNSPECIFIED CONCOMITANT MICROCATHETER (MC) FROM THE SHEATH AND THE DELIVERY WIRE BECAME ¿BROKEN¿. THE DEVICE WAS REPLACED WITH ANOTHER COIL. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084229 ↗
• MalfunctionJul 2, 2019Unraveled Material; Unraveled Material

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION, THERE WAS STRONG RESISTANCE FELT BETWEEN A MICROCATHETER AND TWO COILS. A DELTAFILL18 20MM X 60CM (DLF182060, L14332) AND A DELTAFILL18 12MM X 42CM ((DLF181242, L14321). THE PHYSICIAN ATTEMPTED TO REMOVE THE COMPLAINT COILS, HOWEVER, BOTH COILS GOT STUCK IN THE MIDDLE OF THE MICROCATHETER AND THEY UNRAVELED IN THE MICROCATHETER. AFTER THAT, THE MICROCATHETER WITH THE COMPLAINT COILS WERE REMOVED TOGETHER FROM THE PATIENT¿S BODY, AND THE COMPLAINT COILS WERE REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED BY APPROACHING THE SAME MICROCATHETER AGAIN TO THE TARGET LESION AND NON-CERENOVUS COILS WERE ADVANCED SMOOTHLY IN THE MICROCATHETER WITHOUT GETTING STUCK. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICES. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753059 ↗
• MalfunctionJun 18, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO PREVENT AN ENDOLEAK AT THE INTERNAL ILIAC ARTERY, A COMPETITIVE COIL WAS PLACED WITHOUT ANY ISSUE BUT THE DELTAFILL18 20 MM X 60 CM COIL (DLF182060/S11472) FAILED TO DETACH AND WAS REMOVED; IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WAS WITHOUT HAVING TO REPLACE THE DELTAFILL18 COIL. THERE WAS NO 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. THE DELTAFILL18 COIL WAS NOT AVAILABLE TO BE RETURNED FOR PRODUCT ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611037 ↗
• MalfunctionJun 28, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DETACHMENT ISSUE WAS EXPERIENCED WHEN USING A DELTAFILL18 20MM X 60CM COIL (DLF182060/S12428). THE PROCEDURE WAS EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE COIL DID NOT DETACH AFTER FOUR ATTEMPTS AND ON THE FIFTH ATTEMPT THE COIL DETACHED IN THE MICROCATHETER END. IT WAS REPORTED THAT A PRE-DEPLOYMENT CHECK WAS PERFORMED; UPON PRESSING THE POWER BUTTON ALL LIGHTS ILLUMINATE AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME DCB AND THE CONNECTING CABLE WERE USED WITH SUBSEQUENT COILS. NO PATIENT CONSEQUENCE WAS REPORTED DUE TO THE EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6674016 ↗