DELTAFILL DLF180625Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886704076933), received between Sep 7, 2017 and Jun 30, 2025 — classified as 5 injuries, 25 malfunctions.

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

• MalfunctionJun 30, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING THE INFERIOR MESENTERIC ARTERY TO TRAT AN ABDOMINAL AORTIC ANEURYSM, WHICH WAS PERFORMED PRIOR TO A STENT GRAFT PLACEMENT, THE DEVICES WERE USED IN ACCORDANCE TO THE IFU. AFTER USING A DIAGNOSTIC CATHETER AND MICROCATHETER (COILING SUPPORT CATHETER (MEDICOS HIRATA)), THE PHYSICIAN CHECKED THE ELECTRICAL CONTINUITY OF THE FIRST COIL, A 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / 0732535S), BUT IT DID NOT RESPOND. IT WAS REPLACED WITH A SECOND 6MM X 25CM DELTAFILL 18 COIL (DLF180625) FROM THE SAME LOT (0732535S). THE SECOND COIL WAS PLACED INTO THE TARGET LESION. AFTER CHECKING THE ELECTRICAL CONTINUITY, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL; ¿A SOUND WAS MADE, BUT IT COULD NOT BE DETACHED.¿ THE SECOND COIL WAS REPLACED WITH ANOTHER 6MM X 25CM DELTAFILL 18 COIL (DLF180625) AND THE NEW COIL WAS IMPLANTED WITHOUT ANY ISSUE. THE COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. ON 15-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, ALL C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352678 ↗
• MalfunctionJun 30, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING THE INFERIOR MESENTERIC ARTERY TO TRAT AN ABDOMINAL AORTIC ANEURYSM, WHICH WAS PERFORMED PRIOR TO A STENT GRAFT PLACEMENT, THE DEVICES WERE USED IN ACCORDANCE WITH THE IFU. AFTER USING A DIAGNOSTIC CATHETER AND MICROCATHETER (COILING SUPPORT CATHETER (MEDICOS HIRATA), THE PHYSICIAN CHECKED THE ELECTRICAL CONTINUITY OF THE FIRST COIL, A 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / 0732535S), BUT IT DID NOT RESPOND. IT WAS REPLACED WITH A SECOND 6MM X 25CM DELTAFILL 18 COIL (DLF180625) FROM THE SAME LOT: (0732535S). THE SECOND COIL WAS PLACED INTO THE TARGET LESION. AFTER CHECKING THE ELECTRICAL CONTINUITY, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL; ¿A SOUND WAS MADE, BUT IT COULD NOT BE DETACHED.¿ THE SECOND COIL WAS REPLACED WITH ANOTHER 6MM X 25CM DELTAFILL 18 COIL (DLF180625) AND THE NEW COIL WAS IMPLANTED WITHOUT ANY ISSUE. THE COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. ON 15-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352671 ↗
• InjuryOct 24, 2024Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING A LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM WITH NORMAL ANATOMY USING A CEREBASE (UNKNOWN CATALOG AND LOT NUMBER), A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) AND A TOTAL OF SIX COILS. IT WAS REPORTED THAT THREE OF THE SIX COILS ¿GOT STUCK IN THE MICROCATHETER AND COULD NOT BE REMOVED.¿ THE THREE COILS WERE: A 6MM X 25CM DELTAFILL 18 (DLF180625 / 30719513), A 5MM X 20CM DELTAFILL 18 (DLF180520 / 30942962), AND A 4MM X 10CM DELTAFILL 10 (DLF100410 / 30871956). IT WAS REPORTED THAT ¿WHEN TRYING TO PULL THE FIRST COIL [THE 6MM X 25CM DELTAFILL 18 (DLF180625 / 30719513)] OUT OF THE CONCOMITANT SL-10® MICROCATHETER (STRYKER), THE PUSHER WIRE TORE OFF AND THE COIL BECAME STUCK IN THE MICROCATHETER. THE MICROCATHETER THEREFORE, HAD TO BE REMOVED. IT WAS REPORTED THAT PRIOR TO THIS COIL, THE PREVIOUS THREE COILS ¿COULD BE PUSHED THROUGH THE SAME [MICROCATHETER].¿ THIS FIRST SL-10® MICROCATHETER (STRYKER) WAS NOT SAVED. THE SAME INCIDENT OCCURRED TWICE MORE DURING COIL EMBOLIZATION WITH THE 5MM X 20CM DELTAFILL 18 (DLF180520 / 30942962), AND A 4MM X 10CM DELTAFILL 10 (DLF100

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524555 ↗
• MalfunctionJul 24, 2024Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE 6MM X 25CM DELTAFILL 18 (DLF180625 / 31178126) WAS OPENED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT WAS TARGETING ANEURYSM ON THE INTERNAL CAROTID ARTERY (ICA), IT WAS IMMEDIATELY VERIFIED THAT IT WAS DAMAGED. A NEW COIL WAS USED AS REPLACEMENT. THE PROCEDURE WAS REPORTEDLY DELAYED BY 3 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 16-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE EVENT DATE WAS 09-JUL-2024. THE REPORTED DAMAGE WAS OBSERVED ¿WHEN THEY TRIED TO DEPLOY THE COIL.. IN THAT MOMENT, THE COIL START GOING ¿OUT¿ FOR A LATERAL ¿WALL¿¿ SO THEY DID NOT DEPLOY IT. [TOOK] IT OUT AND OPENED ANOTHER ONE. THEY SPENT 3 MINUTES MAXIMUM IN THE PROCEDURE [TO] GET ANOTHER COIL.¿ THE INFORMATION INDICATED THAT THE DAMAGE WAS OBSERVED ON THE ¿LATERAL OPEN.¿ THE REPLACEMENT COIL WAS ANOTHER 6MM X 25CM DELTAFILL 18 (DLF180625). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. THE PHYSICIAN DID NOT CONSIDER THE 3-MINUTE DELAY TO BE CLINICALLY SIGNIFICANT, AS INDICATED BY THE INFORMATION, THE PHYSICIAN WAS ¿VERY CALM AND RELAXED,¿ HE COMMENTED TO THE SALES REPRESENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820990 ↗
• MalfunctionJul 22, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF THE AXILLARY ARTERY VIA SIMPLE TECHNIQUE, THE COMPLAINT COIL, A 6MM X 25CM DELTAFILL 18 (DLF180625 / 31178127) WAS USED FOR FILLING. IT WAS REPORTED THAT THE COIL BECAME UNRAVELED WHILE BEING INSERTED AND REMOVED SEVERAL TIMES. AS A RESULT, THE COIL WAS REMOVED ALONG WITH THE CONCOMITANT MICROCATHETER, AN EXCELSIOR® 1018® MICROCATHETER (STRYKER). AFTER THE MICROCATHETER WAS INSERTED INTO THE TARGET LESION AGAIN, ADDITIONAL COILS WERE IMPLANTED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ON 09-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE COIL HAD BEEN WITHDRAWN AND REPOSITIONED SEVERAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801504 ↗
• MalfunctionMar 6, 2024Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING A LESION ON THE SUPERIOR GLUTEAL ARTERY PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), THE PARENT CATHETER WAS INSERTED INTO THE LEFT INTERNAL ILIAC ARTERY AND THE CONCOMITANT PROWLER SELECT PLUS MICROCATHETER WAS INSERTED INTO THE PARENT CATHETER TO MAKE THE APPROACH TO THE SUPERIOR AND INFERIOR ILIAC ARTERIES. THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / 30942967) WAS INSERTED AND STRONG RESISTANCE WAS FELT INSIDE THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN PULLED THE COIL OUT OF THE PATIENT¿S ANATOMY AND OBSERVED THAT THE COIL HAD UNRAVELED. IT WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE WHICH WAS IMPLANTED. SUBSEQUENTLY, ADDITIONAL COILS WERE IMPLANTED AND THE COIL EMBOLIZATION WAS COMPLETED. A STENT GRAFT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. ON 21-FEB-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, THE REPORTED ISSUE OCCURRED DURING THE COIL INSERTION THROUGH THE MICROCATHETER, BEFORE EXITING THE MICROCATHETER. THE COIL HAD NOT BEEN WITHDRAWN AND REPOSITIONED;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853210 ↗
• MalfunctionDec 12, 2023Material Rupture; Material Rupture

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET LOCATED ON THE INFERIOR MESENTERIC ARTERY AND THE RIGHT ACCESSORY RENAL ARTERY, A 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / 30915600) WAS USED. IMMEDIATELY AFTER THE PHYSICIAN STARTED TO DELIVERY THE DEVICE, THE COIL PROTRUDED FROM AROUND THE CONNECTION OF THE SHEATH BETWEEN THE GREEN AND WHITE. THE COIL COULD NOT BE USED. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE EXCELSIOR® 1018® MICROCATHETER (STRYKER). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 12-DEC-2023, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312676 ↗
• MalfunctionFeb 14, 2023Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, THE PROCEDURE WAS A VV SHUNT EMBOLIZATION, AND AN ANGIOGRAPHY CATHETER WAS DELIVERED TO THE V SHUNT LESION. A PROWLER SELECT LPES 45 DEG TIP MICROCATHETER (606S155FX, 30937697) WAS DELIVERED TO THE LESION AND COIL EMBOLIZATION STARTED. THE MC WAS PREPPED AND INSERTED. A DELTAFILL18 6MM X 25CM COIL (606S155FX, 30937697) WAS INSERTED INTO THE MC AFTER CONFIRMATION FOR USE. HOWEVER, RESISTANCE OCCURRED WHEN THE COIL APPROACHED TO THE LESION AND RESISTANCE BECAME STRONGER AND STRONGER. THE COIL BECAME STUCK, AND IT WAS RETRACTED BUT DETACHED INSIDE THE MC. THE MC AND THE COIL WERE REPLACED WITH OTHER DEVICES AND EMBOLIZATION COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS SHUNT VESSEL FROM THE COMMON JUGULAR VEIN TO THE VEIN. OTHER CONCOMITANT DEVICE IS A Y-CONNECTOR (OKAY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371442 ↗
• MalfunctionJan 18, 2023Break; Positioning Problem; Break; Positioning Problem

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY ASSOCIATED WITH HEMATOMA (APPROXIMATE 5MM). PARENT CATHETER(S) WERE DELIVERED TO THE INTERNAL ILIAC ARTERY AND A MICROCATHETER (PROWLER SELECT PLUS) WAS DELIVERED TO THE DISTAL BLOOD VESSEL. SEVERAL DELTAFILL18 COILS WERE USED AND COIL EMBOLIZATION STARTED. THE COMPLAINT COIL, A DELTAFILL18 6MM X 25CM (DLF180625, 30585432) WAS BEING USED AS THE FOURTH COIL. THE MICROCATHETER AND THE PARENT CATHETER KICKED BACK TOGETHER. THE PHYSICIAN RE-SHEATHED THE COMPLAINT COIL AND THE MICROCATHETER BUT THE SHEATH GOT DAMAGED AND RE-SHEATHING WAS IMPOSSIBLE. AFTER THAT, ONE PUSHABLE COIL WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS NOT DONE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. THERE WAS NO NECK REMODELING UTILIZED. THE MC WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MC. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196595 ↗
• MalfunctionDec 12, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A PULMONARY ARTERIOVENOUS FISTULA, A DELTAFILL18 6MM X 25CM COIL (DLF180625, 30915596) WAS USED AS THE THIRD COIL AFTER TWO DELTAFILL18 COILS (8×35) (6×25) WERE IMPLANTED. THE PHYSICIAN CHECKED THE ELECTRICAL CONTINUITY. HOWEVER, THE ENERGIZING LAMP ON THE DETACHABLE CONTROL BOX (DCB2) DID NOT LIGHT UP. THE DCB WAS REPLACED WITH ANOTHER BOX, BUT THE SAME ISSUE CONTINUED. THE ENPOWER CONTROL CABLE (ECB00018200, 30952244) WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE CONTINUED. THE PHYSICIAN JUDGED THIS ISSUE WAS CAUSED BY THE COMPLAINT COIL. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER DELTAFILL18 COIL (6×25) AND THE LAMP WAS ABLE TO BE ILLUMINATED WITH THE REPLACEMENT COIL. COIL EMBOLIZATION WAS CONTINUED, AND THE PROCEDURE WAS COMPLETED AFTER SIXTEEN DELTAFILL18 COILS, TWO C STOPPER,S AND FOUR NESTER COILS WERE USED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. A LEONISMOVA MICROCATHETER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958523 ↗
• MalfunctionJul 25, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A PRE-SG COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY, A 6MM X 25CM DELTAFILL18 COIL (DLF180625, 30719513) WAS IMPLANTED TO THE TARGET LESION AND ENERGIZED. THE ENERGIZING LAMP WAS NOT LIGHT UP AND THE COIL WAS NOT ABLE TO BE DETACHED. ENERGIZATION CHECK WAS NOT PERFORMED BEFORE INSERTION OF THE COIL. THE ENPOWER DETACHMENT CONTROL BOX (DCB2000500) AND THE ENPOWER CONTROL CABLE (ECB00018200, 30727816) WERE REPLACED, BUT THE COIL WAS STILL NOT DETACHED. THE COMPLAINT COIL WAS REMOVED AND REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS NOT DONE. THERE WAS NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094007 ↗
• MalfunctionMay 4, 2022Break; Positioning Problem; Break; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF A MONUMENTAL ANEURYSM, EMBOLIZATION OF THE MATERNAL BLOOD VESSEL OF THE DISTAL SIDE, EMBOLIZATION OF THE ANEURYSM AND EMBOLIZATION OF THE PROXIMAL MATERNAL BLOOD VESSEL WERE PERFORMED. AN 8MM X 35CM DELTAFILL 18 COIL (DLF180835 / 30715039) WAS USED FOR THE DISTAL COIL EMBOLIZATION. THE COMPLAINT PRODUCT WAS REPORTED AS UNABLE TO MAKE THE SHAPE AS THE PHYSICIAN INTENDED. THE PHYSICIAN TRIED TO RESHEATH THE COIL THE SHEATH GOT DAMAGED. THE COMPLAINT COIL WAS REMOVED AND A SECOND COIL, A 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / 30649196) WAS INSERTED AND THE PHYSICIAN TRIED TO WIND IT BUT THE SAME ISSUE OCCURRED. THIS WAS THE FIRST TIME THE COILS WERE USED BY THE PHYSICIAN ON A TRIAL BASIS. BECAUSE OF THE CAREFUL TECHNIQUE, THE PHYSICIAN HAD TO RE-WIND THE COIL REPEATEDLY. CONTINUOUS FLUSH WAS NOT MAINTAINED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE PRODUCTS ARE NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274620 ↗
• MalfunctionApr 11, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A PRE-STENT GRAFT COIL EMBOLIZATION PROCEDURE TARGETING A LESION ON THE INTERNAL ILIAC ARTERY (IIA), CATHETER(S) APPROACHED THE IIA AND COIL EMBOLIZATION INITIATED. THE 8MM X 35CM DELTAFILL 18 (DLF180835 / 30633416) WAS INSERTED AND ADVANCED THROUGH A MICROCATHETER (UNSPECIFIED BRAND), BUT THERE WAS INTENSE RESISTANCE FELT BEFORE THE COIL EXITED THE MICROCATHETER. THE COIL WAS REMOVED AND IT WAS CONFIRMED THAT THE COIL COMPONENT GOT DEFORMED. THE PHYSICIAN THINKS THIS DEFORMATION MIGHT HAVE BEEN DUE TO THE COIL BEING PUSHED WITH FORCE. IT WAS REPLACED WITH ANOTHER 8MM X 35CM DELTAFILL 18 (DLF180835) AND THIS REPLACEMENT COIL WAS IMPLANTED. THE 6MM X 25CM DELTAFILL 18 (DLF180625 / 30585432) WAS USED AFTER THE IMPLANTATION OF THE REPLACEMENT 8MM X 35CM DELTAFILL 18 COIL WAS IMPLANTED. THE 6MM X 25CM DELTAFILL 18 WAS PUSHED BACK AND FORTH, HOWEVER THE COIL COMPONENT GOT STRETCHED. IT WAS REPLACED WITH ANOTHER DELTA COIL AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DOCUMENTED THAT THE 8MM X 35CM DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079418 ↗
• MalfunctionJan 25, 2022Stretched; Difficult to Advance; Material Twisted/Bent; Stretched; Difficult to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A PEDIATRICS COIL EMBOLIZATION OF AORTO-PULMONARY COLLATERAL ARTERIES (APCA ) BEFORE FONTAN PROCEDURE, THE PHYSICIAN ACCESSED THE INTERNAL THORACIC ARTERY. A DELTAFILL18 COIL 6MM X 25CM (DLF180625, 30550285) WAS USED AFTER AN AZUL COIL WAS USED. THE DELTAFILL18 COIL WAS DETACHED BUT THERE WAS AN INTENSIVE RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND AN UNSPECIFIED MICROCATHETER WHEN BEING REMOVED. IT WAS REMOVED TOGETHER WITH THE MICROCATHETER. IT WAS CONFIRMED THAT THE TIP OF THE COIL DELIVERY WAS BENT. AFTER THAT, THE MICROCATHETER WAS REPLACED WITH ANOTHER ONE AND IED COIL(S) WERE IMPLANTED. NO SIGNIFICANT IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS THE RIGHT INTERNAL THORACIC ARTERY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BRAND OF THE SHEATH INTRODUCER, THE GUIDING CATHETER AND THE MICROCATHETER ARE UNKNOWN. AN ASAHI CHIKAI BLACK GUIDEWIRE WAS USED. NO BALLOON CATHETER WAS USED. THE COMPLAINT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER, AND IT WAS CONFIRMED THE COMPLAINT COIL WAS UNRAVELED. IT WAS DETACHED WITHOUT BEING SEPARATED MORE THAN TWO PIECES. THE REMOVED SYSTEM WAS OBSERVED AND NOTICED THE DELIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341656 ↗
• 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, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 48MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED AN ENDOLEAK (TYPE UNKNOWN) 362 DAYS AFTER THE PROCEDURE. THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS THE AFX ENDOVASCULAR AAA SYSTEM. A TOTAL OF THREE SPECTRA DELTAFILL18 (CERENOVUS) COILS: ONE (1) 6MM X 25CM DELTAFILL 18 (DLF180625 / LOT# UNKNOWN) AND TWO (2) 5MM X 20CM DELTAFILL 18 (DLF180520 / LOT# UNKNOWN) WERE IMPLANTED AT THE LUMBAR ARTERY. THERE WERE REPORTEDLY NO PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. FLUOROSCOPY TIME WAS 56 MINUTES. THE PATIENT WAS HOSPITALIZED NINE DAYS. THE COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 13112173 ↗
• InjurySep 29, 2021Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A BALLOON-ASSISTED COIL EMBOLIZATION WITH THE TARGET LESION ON THE HEPATIC ARTERY (4MM), THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / LOT# UNKNOWN) WAS USED AS THE FIRST COIL. ADDITIONAL COIL(S) WAS IMPLANTED; WHEN THE FOURTH COIL WAS IMPLANTED, THE COMPLAINT COIL ¿WAS FLOWN TO THE DISTAL END.¿ ADDITIONAL INFORMATION PROVIDED ON 22 SEPTEMBER 2021, INDICATED THAT ADDITIONAL COIL(S) WERE IMPLANTED AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION PROVIDED ON 24 SEPTEMBER 2021 INDICATED THAT THE DETACHED 6MM X 25CM DELTAFILL 18 COIL MIGRATED TO THE PARENT VESSEL AND MOVED DISTALLY IN THE PARENT VESSEL BY THE BLOOD FLOW. IT WAS NOT CLEAR IF CONTINUOUS FLUSH WAS MAINTAINED. AN ATTENDANT BALLOON CATHETER (TERUMO CLINICAL SUPPLY) AND A PROWLER SELECT PLUS MICROCATHETER WERE USED DURING THE PROCEDURE. ON 27 SEPTEMBER 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED AFTER THE FOURTH COIL WAS PLACED, THE FIRST COIL (COMPLAINT COIL) SEPARATED FROM THE COIL MASS AND MIGRATED DISTALLY. ADDITIONAL COIL WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN DID NOT TREAT THE SEPARATED AND DISTALLY MIGRATED COIL. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548695 ↗
• MalfunctionJun 1, 2021Material Rupture; Material Rupture

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR A TYPE II ENDOLEAK, THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L16840) WAS USED AS THE SECOND COIL, BUT THE SHEATH BECAME TORN AND THE WIRE AND COIL SECTION WERE EXPOSED. THE DEVICE WAS USED AS PER THE INSTRUCTION FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE AND CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGH THE MICROCATHETER. THE REPORTED ISSUE DID NOT RESULT IN ANY BLOOD FLOW RESTRICTION / REDUCTION. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN DAMAGED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 31 MAY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917412 ↗
• InjuryApr 28, 2020Material Separation; Unraveled Material; Positioning Problem; Material Separation; Unraveled Material; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE GASTRODUODENAL ARTERY (GDA), THE CONCOMITANT CARRY LEON MICROCATHETER (UTM) WAS DELIVERED TO THE LESION AND A 12MM DELTA COIL WAS INSERTED BUT ITS SIZE WAS NOT AN APPROPRIATE FIT FOR THE LESION AND THE COMPLAINT COIL, A 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L14373) WAS CHOSEN AS THE REPLACEMENT COIL. THE PHYSICIAN ATTEMPTED TO WIND THE COIL IN A LIMITED SPACE (DUE TO THROMBUS IN THE ANEURYSM), BUT THE CONCOMITANT MICROCATHETER KICKED BACK. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN WINDED THE COMPLAINT COIL ¿AS HE USED THE CATHETER, BUT IT WAS NOT WINDED COMPLETELY.¿ HE TRIED TO WITHDRAW THE COIL, BUT IT BECAME UNRAVELED. A SNARE CATHETER WAS INSERTED FROM THE ARM; HOWEVER, IT CAUGHT A PORTION OF THE COIL THAT WAS NOT UNRAVELED. THE SNARE WAS REMOVING THE COIL, BUT THE COIL UNRAVELED AGAIN AND BECAME SEPARATED. THE SNARE CATHETER WAS INSERTED AGAIN FROM THE INGUINAL REGION, BUT THE COIL GOT SEPARATED AGAIN. MOST PARTS OF THE UNRAVELED COIL ARE INSIDE THE ANEURYSM. THE REMAINING PART OF THE COIL IS FLOATING IN THE AORTA. THE PHYSICIAN D

  Patient problems: No Code Available

  MAUDE report 10007057 ↗
• MalfunctionApr 27, 2020Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT BOTH INTERNAL ILIAC ARTERIES (IIA), A SHEATH INTRODUCER (4FR25¿. MEDIKIT) WAS USED. A 6MM X 25CM DELTAFILL18 COIL ((B)(4), L16942) WAS INSERTED INTO A CONCOMITANT MICROCATHETER (BREAKTHROUGH, BOSTON SCIENTIFIC). HOWEVER, THERE WAS A RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER AND THE RESISTANCE MADE THE SHEATH INTRODUCER DAMAGE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THE FINDINGS OF THE DEVICE INVESTIGATION INDICATED THAT THE EMBOLIC COIL WAS NOTED TO BEING STRETCHED, AND MECHANICALLY DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000357 ↗
• MalfunctionMar 17, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION WITH THE TARGET POSITION AT THE INTERNAL ILIAC ARTERY PRIOR TO STENT GRAFTING, A VASCULAR PLUG (UNKNOWN BRAND) WAS IMPLANTED FOLLOWED BY TWO 10MM AZUR COILS (TERUMO INTERVENTIONAL SYSTEMS), THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L11447) WAS USED AND ATTEMPT WAS MADE TO DETACH THE COIL. THE ENPOWER CONTROL CABLE (ECB00018200 / L16610) WITH THE GREEN LIGHT ILLUMINATED INDICATING THE BOX WAS FULLY CHARGE, WAS CONNECTED TO THE ENPOWER DETACHMENT CONTROL BOX 2 (DCB2) (DCB2000500 / C50538) WITH THE COMPLAINT COIL. THE SECOND LIGHT ON THE BOTTOM OF THE CONTROL BOX INDICATED NO CHARGE WAS ILLUMINATED. THE COIL WAS DISCONNECTED FROM THE ENPOWER CONTROL CABLE, BUT THE LIGHT REMAINED ILLUMINATED. THE ENPOWER CONCTROL CABLE WAS REPLACED WITH ANOTHER ENPOWER CABLE (ECB00018200 / K10031), BUT THE SAME ISSUE CONTINUED. THE ENPOWER DETACHMENT CONTROL BOX 2 WAS REPLACED WITH ANOTHER ONE FROM THE SAME LOT (C50538) BUT THE ISSUE REMAINED UNRESOLVED. THE COMPLAINT COIL WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR COIL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845731 ↗
• MalfunctionFeb 3, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION AT THE INTERNAL ILIAC ARTERY (IIA), THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L13929) WAS INSERTED INTO THE CONCOMITANT LEONIS MOVA MICROCATHETER (SUMIMOTO BAKELITE CO. LTD.) BUT THERE WAS STRONG RESISTANCE FELT AFTER 10CM OF THE COIL EXITED THE MICROCATHETER. THE COIL COULD NOT BE ADVANCED NOR WITHDRAWN. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL AND THE CONCOMITANT MICROCATHETER WERE REMOVED FROM THE PATIENT WHERE THE COIL BECAME UNRAVELED. THE PROCEDURE WAS RESUMED USING ANOTHER MICROCATHETER AND COIL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660207 ↗
• MalfunctionDec 23, 2019Stretched; Unraveled Material; Stretched; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-ENDOVASCULAR ANEURYSM REPAIR (EVAR) EMBOLIZATION AT THE INTERNAL ILIAC ARTERY, THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L14373) WAS USED AS A FILLING COIL, BUT THERE WAS A RESISTANCE FELT BETWEEN THE HUB OF THE MICROCATHETER AND THE COIL. THIS OCCURRED WHEN THE COIL WAS DELIVERED TO THE TARGET LESION. THE COMPLAINT COIL WAS RE-SHEATHED, BUT IT BECAME UNRAVELED. ANOTHER 6MM X 25CM DELTAFILL 18 COIL WAS USED AND THE PROCEDURE WAS COMPLETED WITH 11 SPECTRA COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511361 ↗
• MalfunctionNov 12, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 6MM X 25CM DELTAFILL18 COIL (DLF180625, L15428) WAS BEING USED AS THE SECOND COIL. 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 REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309364 ↗
• MalfunctionOct 21, 2019Premature Separation; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT THE VERTEBRAL ARTERY-PARENT ARTERY OCCLUSION (VA-PAO), A MICROCATHETER WAS INSERTED AND DELIVERED TO THE LESION. A 6MM X 25CM DELTAFILL18 COIL (DLF180625, L14325) WAS USED AFTER THE COILS DELTA 5MM AND VERSATILE FILL COILS (VFC) WERE USED. A BALLOON GUIDING CATHETER WENT DOWN WHILE THE COIL WAS WINDED, THEREFORE THE COMPLAINT COIL WAS RE-SHEATHED. DURING THE RE-SHEATHING, THERE WAS A RESISTANCE FELT WHEN THE COIL WAS INSERTED INTO A SHEATH FROM A Y CONNECTOR. THE PHYSICIAN KEPT RE-SHEATHING IT AND IT WAS DETACHED. THEREFORE, IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214551 ↗
• MalfunctionMay 7, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE MAJOR AORTO-PULMONARY COLLATERAL ARTERY (MAPCA) COIL EMBOLIZATION PROCEDURE TARGETING THE LESION AT THE COLLATERAL CIRCULATION COMING FROM THE RIGHT INTERNAL MAMMARY ARTERY, WHEN THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L11591) WAS APPROACHING THE TARGET LESION, RESISTANCE WAS FELT, AND THE PHYSICIAN PUSHED AND WITHDRAWN THE COIL. THEN IT WAS CONFIRMED THAT THE COIL BECAME UNRAVELED. THE COIL WAS THEN REMOVED FROM THE PATIENT¿S BODY TOGETHER WITH THE CONCOMITANT LIGHTHOUSE® MICROCATHETER (PIOLAX MEDICAL). THE PROWLER SELECT PLUS LPES MICROCATHETER WAS USED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT THE TORTUOSITY OF THE PATIENT¿S VESSELS WAS SEVERE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. ALL THE DEVICES WERE HANDLED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT DEVICE WAS DISCARDED DUE TO INFECTIOUS DISEASES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588472 ↗