DELTAFILL DLF180415Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886704077206), received between Feb 1, 2017 and Sep 28, 2026 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break; Device Difficult to Setup or Prepare; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926013 ↗
• MalfunctionMay 26, 2026Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY OF SPLENIC ARTERY TO TREAT SPLENIC ARTERY ANEURYSM; AFTER APPROACHING THE TARGET LESION, COIL EMBOLIZATION OF THE SPLENIC ARTERY ANEURYSM WAS INITIATED. THE 4MM X 15CM DELTAFILL 18 (DLF180415 / 31073003) WAS DELIVERED THROUGH THE PROWLER SELECT PLUS MICROCATHETER WITHOUT ¿ANY FEELING OF STRANGENESS; HOWEVER, THE COIL COULD NOT BE VISUALIZED UNDER FLUOROSCOPY.¿ THE DELTAFILL 18 COIL WAS WITHDRAWN AND VISUALLY INSPECTED OUTSIDE THE PATIENT¿S BODY, BUT THE COIL WAS STILL NOT LOCATED. IT WAS THEN REPORTED THAT, ¿CONSIDERING THE POSSIBILITY THAT THE COIL HAD FRACTURED WITHIN THE MICROCATHETER, THE MICROCATHETER WAS REMOVED AND INSPECTED OUTSIDE THE PATIENT¿S BODY; HOWEVER, THE COIL WAS NOT FOUND INSIDE THE MICROCATHETER.¿ THE DELTAFILL 18 COIL WAS REPLACED WITH A NEW COIL AND THEN THE SAME MICROCATHETER WAS USED. NO FURTHER ISSUES OCCURRED. CONTINUOUS FLUSH WAS MAINTAINED. THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT.ON 18-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN INVOLVED IN THE PROCEDURE WAS INTERVIEWED AND REPORTED THE SITUATION AS FOLLOWS: ¿AS THE COIL WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284384 ↗
• MalfunctionAug 4, 2025Device Difficult to Setup or Prepare; Separation Failure; Device Difficult to Setup or Prepare; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A LUMBAR ARTERY DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTA ANEURYSM, ALL DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS). AFTER APPROACHING THE LUMBAR ARTERY WITH A 4F DIAGNOSTIC CATHETER AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC), THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / 0632519S) WAS USED AS THE FIRST COIL. DURING THE ATTEMPT TO DETACH THE COIL, THE POWER INDICATOR LIGHT DID NOT ILLUMINATE, AND THE COIL COULD NOT BE ENERGIZED. THE CONTROLLER BOX WAS TURNED OFF AND OFF. TROUBLESHOOTING STEPS AND RECONNECTION WERE PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. IT WAS THEN REPORTED THAT ¿TO PREVENT THROMBUS FORMATION ON THE COIL, IT WAS DECIDED TO RETRIEVE THE COIL ONCE. DURING THE RETRIEVAL ATTEMPT, THE SHEATH GOT DAMAGED, MAKING RE-SHEATHING THE COIL IMPOSSIBLE. NO UNRAVELING, KINKS, OR OTHER ISSUES WERE OBSERVED WITH THE DELIVERY WIRE OR THE COIL.¿ THERE WAS NO OTHER J&J MEDTECH COIL OF THE SAME SIZE AVAILABLE, THE 4MM X 15CM DELTAFILL 18 COIL WAS REPLACED WITH A COMPETITOR COIL. SUBSEQUENTLY, THE PROCEDURE CONTINUED USING COMPETITOR COILS AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709324 ↗
• MalfunctionFeb 18, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION PRIOR TO THE RETROPERITONEAL TUMOR PROCEDURE, A 5FR DIAGNOSTIC CATHETER, BISHOP HF(PIOLAX) AND MARVEL MICROCATHETER WERE ADVANCED TO THE TARGET LESION (UNKNOWN ARTERY). AFTER 2 J&J COILS, 6 P-COILS AND 1 D-COILS (NON J&J BRAND ) WERE IMPLANTED, THE DELTAFILL18 4MM X 15CM COIL (DLF180415, 31178111) WAS USED AS A TENTH COIL. THE DELTAFILL18 COIL COULD NOT BE WOUND AT THE TARGET VESSEL, THE COIL WAS PUSHED AND PULLED FROM MICROCATHETER (MC) SEVERAL TIMES. WHEN THE COIL WAS RETRACTED (PULLED) INTO THE MICROCATHETER, THE COIL GOT EARLY DETACHED IN A PLACE WHERE IT WAS NOT INTENDED. THE COIL WAS RETRIEVED FROM THE PATIENT¿S BODY WITH THE MICROCATHETER AND COLLECTED FROM THE MICROCATHETER BY FLUSHING. AFTER THAT, ANOTHER 2 COILS WITH THE SAME LOT AND 3 P-COILS WERE IMPLANTED, THE ANGIOGRAPHY WAS CONDUCTED TO CONFIRM, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403876 ↗
• MalfunctionFeb 6, 2025Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INFERIOR MESENTERIC ARTERY PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), THIS WAS LIKELY THE SECOND COIL EMBOLIZATION WITH SPECTRA COILS FOR THE PHYSICIAN WHO PERFORMED THE PROCEDURE. THE DEVICES WERE USE IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). DURING THE DELIVERY OF TWO (2) 3MM X 12CM DELTAFILL 18 COILS (DLF180312) FROM THE SAME LOT (31178103), THE PHYSICIAN FELT STRONG RESISTANCE INSIDE THE CONCOMITANT LEONIS MOVA¿ MICROCATHETER (SUMIMOTO BAKELITE) AND THE DELIVERY WIRES OF BOTH COILS GOT KINKED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COILS WERE REPLACED WITH A 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / 31073004) AND IT WAS REPORTED THAT ¿THOUGH SOME RESISTANCE WAS FELT INSIDE THE MICROCATHETER, THE 4MM X 15CM DELTAFILL 18 COIL COULD BE WOUND. THEN [THE PHYSICIAN] ATTEMPTED TO DETACH THE COIL, ENERGIZATION FAILURE WAS FOUND, AND THE COIL COULD NOT BE DETACHED.¿ THE 4MM X 15CM DELTAFILL 18 COIL WAS REPLACED WITH EMBOLD COILS (BOSTON SCIENTIFIC) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329099 ↗
• MalfunctionNov 18, 2024Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  AS REPORTED BY THE FIELD, THIS WAS AN ENDOVASCULAR EMBOLIZATION OF MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCA). A 5FR DIAGNOSTIC CATHETER AND PROWLER SELECT PLUS WERE ADVANCED TO INTERNAL THORACIC ARTERY, AND THE COIL EMBOLIZATION WAS INITIATED. AFTER 5 J&J COILS WERE IMPLANTED TO INTERNAL THORACIC ARTERY, THE DELTAFILL18 4MM X 15CM COIL (DLF180415, 31178117) WAS USED AS THE SIXTH COIL. DURING INSERTION, THE MICROCATHETER (MC) JUMPED AND DEVIATED FROM THE TARGET SITE. WHEN THE COIL WAS PUSHED AND PULLED SEVERAL TIMES, THE COIL GOT EARLY DETACHED INSIDE OF THE MICROCATHETER. THE COIL WAS RETRIEVED FROM THE PATIENT¿S BODY WITH THE MICROCATHETER (MC). AFTER THAT, THE EMBOLIZATION TO INTERNAL THORACIC ARTERY WAS COMPLETED, AND ANOTHER 5 J&J COILS WERE IMPLANTED TO ANOTHER BRANCH. THE ANGIOGRAPHY WAS CONDUCTED TO CONFIRM, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS RIGHT INTERNAL THORACIC ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707942 ↗
• MalfunctionJul 6, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT COIL EMBOLIZATION FOR SPLENIC ARTERY BRANCH BLEEDING. THE PATIENT HAD UNDERGONE COIL EMBOLIZATION THE DAY BEFORE, BUT THE BLEEDING HAD NOT STOPPED. THEREFORE, THE PATIENT HAD TO BE RE-TREATED. AFTER A GUIDE CATHETER WAS DELIVERED TO THE CELIAC ARTERY, A PROWLER SELECT PLUS LPES MICROCATHETER WAS INSERTED. SIX (6) SPECTRA COILS WERE USED UNDER CONTINUOUS FLUSH. THE COMPLAINT COIL, A 4MM X 15CM DELTAFILL 18 (DLF180415 / 30871961) WAS THEN INSERTED AND AN ATTEMPT WAS MADE TO DETACH THE COIL. HOWEVER, ELECTRICAL CONTINUITY COULD NOT BE FOUND. THERE WAS NO RESPONSE WHEN PRESSING THE BUTTON AND THE COIL COULD NOT BE DETACHED. ELECTRICAL CONTINUITY WAS NOT CHECKED BEFORE INSERTION. THE COIL WAS REMOVED FROM THE PATIENT BECAUSE IT COULD NOT BE DETACHED. IT WAS RETRIEVED WITHOUT UNRAVELING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER 4MM X 15CM DELTAFILL 18 (DLF180415) COIL AND SEVERAL ADDITIONAL UNSPECIFIED COILS. THERE WAS NO REPORTED PATIENT CONSEQUENCE. ON 05-JUL-2023, PRE-SHIPMENT PHOTOS OF THE COMPLAINT DEVICE WERE ADDED TO THE COMPLAINT FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17274697 ↗
• MalfunctionJun 26, 2023Device Difficult to Setup or Prepare; Positioning Problem; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Positioning Problem; Material Split, Cut or Torn

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING A LESION LOCATED AT THE LUMBAR ARTERY, THE COMPLAINT COIL, A DELTAFILL 18 4MM X 15CM (DLF180415/30910221) COULD NOT BE RE-SHEATHED "AFTER FOUR DELTA G3 COILS WERE PLACED". THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. CONTINUOUS FLUSH WAS UNKNOWN. OTHER CONCOMITANT DEVICES ARE UNKNOWN. ADDITIONAL EVENT INFORMATION [07-MAY-2023]: IT WAS REPORTED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER, NO DAMAGE ON THE DEVICE WAS REPORTED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER, AND CONTINUOUS FLUSH HAD BEEN MAINTAINED ON THE MICROCATHETER. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. ADDITIONAL EVENT INFORMATION [30-MAY-2023]: IT WAS REPORTED THAT THE PROCEDURAL SITUATION THAT LED TO RE-SHEATHING WAS COIL POSITIONING DIFFICULTY. THERE WAS A SPLIT EXTENDING TO THE DELIVERY WIRE AROUND THE COIL JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198356 ↗
• MalfunctionNov 1, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A PRE-STENT GRAFT COIL EMBOLIZATION, A DIAGNOSIS CATHETER (4F) AND A PROWLER SELECT PLUS MICROCATHETER. APPROACHED THE INFERIOR MESENTERIC ARTERY. A DELTAFILL18 4MM X 15CM COIL (DLF180415, 30797229) WAS USED FOR THE FIRST COIL BUT THERE WAS AN INTENSIVE RESISTANCE FELT WHEN THE COMPLAINT COIL WAS INSERTED INTO THE PROWLER SELECT PLUS, APPROXIMATE 15CM. THE COMPLAINT COIL WAS RE-SHEATHED. THE MICROCATHETER WAS FLUSHED WITH SALINE AND THE PHYSICIAN ATTEMPTED TO RE-INSERT AGAIN BUT THERE WAS A RESISTANCE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (SAME LOT NUMBER) AND THE REPLACEMENT COIL WAS IMPLANTED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETE WITH FOUR COILS IMPLANTED. THE STATUS OF THE PATIENT HAS BEEN STABLE. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS THE INFERIOR MESENTERIC ARTERY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709062 ↗
• MalfunctionSep 27, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF PULMONARY ARTERIOVENOUS MALFORMATION (PAVM), DELTAFILL COILS WERE USED AS THE FIRST AND SECOND COIL BY COLLATERAL ANCHOR. A 4MM X 15CM DELATFILL COIL (DLF180415, K10406) WAS USED AS THE THIRD COIL. HOWEVER, THERE WAS AN INTENSIVE RESISTANCE FELT IN THE EXSELSIOR SL10 MICROCATHETER (MC). THE PHYSICIAN PUSHED THE COMPLAINT COIL SLOWLY BUT THERE WAS STILL RESISTANCE FELT. THE COMPLAINT COIL WAS REMOVED AND OBSERVED OUTSIDE THE PATIENT 'S BODY. IT SEEMED THE COMPLAINT COIL WAS UNRAVELED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME-SIZED COIL AND THE REPLACEMENT COIL WAS IMPLANTED WITHOUT ANY PROBLEMS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS THE LUNG ARTERY. BALLOON CATHETER(S) WERE USED AS PARENT CATHETER AND A GUIDEWIRE (MYSTER). BLOOD VESSEL WAS EMBOLIZED WITH FLOW WAS CONTROLLED WITH THE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493864 ↗
• MalfunctionJan 21, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET LOCATED ON THE LUMBAR ARTERY, THE 4MM X 15CM DELTAFILL 18 (DLF180415 / 30536998) WAS THE FIRST COIL USED. THE COIL WAS ENERGIZED FOR DETACHMENT, BUT IT WAS NOT ENERGIZED. THE PHYSICIAN MADE SEVERAL ATTEMPTS BUT COULD NOT DETACH THE COIL. THE PHYSICIAN REPLACED THE CONCOMITANT ENPOWER CONTROL CABLE (ECB00018200 / 30666648) AND ATTEMPTED TO DETACH THE COIL AGAIN, BUT THE SAME ISSUE OCCURRED. SUBSEQUENTLY, THE COIL WAS REPLACED WITH ANOTHER COIL FROM ANOTHER LOT NUMBER) AND THE PROCEDURE WAS CONTINUED. THE COIL WAS ENERGIZED AND SUCCESSFULLY DETACHED. THE PROCEDURE WAS RESUMED TO COMPLETION. THERE WAS NO ADVERSE EVENT NOR PATIENT INJURY ASSOCIATED WITH THE ISSUE REPORTED. IT WAS INDICATED THAT THE PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022. THE INFORMATION INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13320075 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE AAA STUDY, AN (B)(6) MALE PATIENT ((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 DELTAFILL18 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 13203861 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE AAA STUDY, A (B)(6) MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 45MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED TYPE II TARGET VESSEL ENDOLEAK SIX 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, GORE ECLUDER LEG. ONE 4MM X 15CM DELTAFIL18 COIL WAS IMPLANTED AT THE LUMBAR ARTERY. FLUOROSCOPY TIME WAS 47 MINUTES. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COMPLAINT COIL REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 13168198 ↗
• MalfunctionNov 2, 2021Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF THE INFERIOR MESENTERIC ARTERY (IMA), A DELTAFILL18 4MM X 15CM COIL ( DLF180415, 30412474) WAS USED. AT THE TIME OF COIL PLACEMENT, ALTHOUGH IT WAS WINDED WELL AT FIRST, THE PHYSICIAN FELT STRONG RESISTANCE GRADUALLY, AND THEN A PROWLER SELECT PLUS MICROCATHETER (PSP) KICKED BACK GREATLY. THE COMPLAINT COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NO DAMAGE WAS NOTED ON THE MICROCATHETER DURING MANIPULATION OF THE DEVICE OR UPON REMOVAL FROM THE PATIENT. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL HAS A STRETCHED CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738087 ↗
• MalfunctionSep 24, 2021Material Rupture; Stretched; Failure to Advance; Material Rupture; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET LESION ON THE LEFT INTERNAL ILIAC ARTERY, THE MOVEMENT OF THE PROWLER SELECT PLUS MICROCATHETER IN THE 5FR IMPRESS® CATHETER (MERIT) WAS SLOW AND IT WAS DIFFICULT TO PUSH. THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / L17032) WAS THE SIXTH COIL USED. IT WAS INSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER. THE COIL WAS REPORTED TO BE STUCK AND UNABLE TO MOVE. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. IN ADDITION, THE COIL WAS EXPOSED FROM THE INTRODUCER SHEATH. THE COIL AND THE PROWLER SELECT PLUS MICROCATHETER WERE REMOVED TOGETHER. THE COIL BECAME UNRAVELED. THE PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH A COMPETITOR MICROCATHETER AND THE COIL WAS REPLACED WITH ANOTHER G3 COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530340 ↗
• MalfunctionJul 27, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOLEAK PROCEDURE OF THE LUMBAR ARTERY, A DELTAFILL18 4MM X 15CM COIL (DLF180415, 30494370) WAS USED TO FILL THE LESION. IT WAS ATTEMPTED TO BE DETACHED BUT THE COIL PART WAS NOT ABLE TO BE CUT. IT WAS REMOVED FROM THE PATIENT. AFTER THAT, ANOTHER COIL WAS DETACHED, AND THE PROCEDURE WAS CONTINUED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SHAFT WAS APPLIED WITH INTENSIVE FORCE DURING THE PROCEDURE. THIS ISSUE MIGHT HAVE CAUSED BY THE FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229495 ↗
• MalfunctionJun 2, 2021Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE TO PLACE AN ARTERIAL INJECTION RESERVOIR, A CONCOMITANT CARRY LEÓN MICROCATHETER (UTM) WAS DELIVERED TO THE LESION. THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / 30392710) WAS USED, BUT THE COIL SIZE DID NOT FIT THE LESION THEREFORE, IT WAS RESHEATHED AS PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, THE INTRODUCER SHEATH GOT DAMAGED AND THE COIL COULD NOT BE RESHEATHED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY. 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 11922789 ↗
• MalfunctionMay 18, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE LUNG ARTERIOVENOUS MALFORMATION (AVM), THREE COMPETITOR COILS WERE USED AND THE COMPLAINT COIL, A 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / L16793) WAS USED. THE COMPLAINT COIL DID NOT FIT THE LESION AS INTENDED; NO FURTHER DETAILS WERE PROVIDED. THE PHYSICIAN WAS ATTEMPTING TO RESHEATH THE COIL, BUT THE SHEATH DID NOT CLOSE PROPERLY AND THE COIL COULD NOT BE RESHEATHED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE PROCEDURE WAS REPORTED AS COMPLETED WITH EIGHT COILS IMPLANTED. THERE WAS NO BLOOD FLOW REDUCTION / RESTRICTION AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED KINKED. BASED ON THE PRODUCT ANALYSIS ON 18 MAY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845509 ↗
• MalfunctionNov 3, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION PROCEDURE TARGETING A HEMORRHAGE, THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) WAS INSERTED AND DELIVERED TO THE TARGET LESION THEN COIL EMBOLIZATION WAS STARTED. THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / L15015) WAS USED BUT IT COULD NOT BE INSERTED INTO THE CONCOMITANT MICROCATHETER. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN CONFIRMED THAT THE COIL HAD BECOME UNRAVELED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10781766 ↗
• MalfunctionMar 31, 2020Stretched; Unraveled Material; Stretched; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION TARGETING A BRONCHIAL ARTERY ANEURYSM, WITH SEVERE BLOOD VESSEL TORTUOSITY, THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / L15418) ENCOUNTERED RESISTANCE DURING ADVANCEMENT THROUGH THE CARRY LEÓN HI-FLO/SELECTIVE MICROCATHETER (UTM). CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS AN ATTEMPT TO RESHEATH THE COIL, BUT THE COIL COULD NOT BE RESHEATHED AS INTENDED AND BECAME UNRAVELED. THE COIL WAS REPLACED WITH A COMPETITIVE COIL AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUE AND WITHOUT ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9904305 ↗
• MalfunctionMar 9, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A BRONCHIAL ARTERIAL ANEURYSM, THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / L15418) DID NOT CONFORM TO THE SHAPE AS THE PHYSICIAN EXPECTED. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL BUT THE RESHEATHING TOOL WAS SLID TO THE PROXIMAL END AND THE COIL COULD NOT BE RESHEATHED. ANOTHER COIL WAS CHOSEN AS REPLACEMENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808456 ↗
• MalfunctionJan 6, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ARTERIOVENOUS MALFORMATION (AVM) COIL EMBOLIZATION AT THE PULMONAL ARTERY, A 3MM X 8CM GALAXY G3 COIL (GLY120308, L15635), A 4MM X 15CM DELTAFILL18 (DLF180415, L15418) AND A 8MM X 24CM GALAXY G3 COIL (GLY120824,L15932) WERE ATTEMPTED TO BE RE-SHEATHED TO CHANGE THE POSITION OF AN EXCELSIOR 1018 MICROCATHETER (MC) AS THE COILS WERE NOT ABLE TO BE MAKE A SHAPE AS THE PHYSICIAN INTENDED. HOWEVER, THE SHEATH GOT DAMAGED AND THEY WERE NOT ABLE TO BE RE-SHEATHED. THE PROCEDURE WAS COMPLETED WITH OTHER COILS. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552771 ↗
• MalfunctionNov 12, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE RENAL ARTERY, THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / S14235) WAS CHOSEN TO BE USED. IT WAS REPORTED THAT THE COIL FAILED TO DETACH AFTER THE PHYSICIAN MADE FIVE DETACHMENT ATTEMPTS. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING THE TARGET®COIL (STRYKER). A TOTAL OF FIFTEEN SPECTRA COILS WERE USED IN THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313108 ↗
• MalfunctionNov 7, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, PRE-SG COIL EMBOLIZATION AT THE RIGHT INTERNAL ILIAC ARTERY, A 4MM X 15CM DELTAFILL18 COIL (DLF180415, S13278) WAS USED AS THE THIRD COIL BUT THE SHEATH INTRODUCER BECAME DAMAGED. IT OCCURRED WHEN THE COIL WAS RE-SHEATHED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. 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 Consequences Or Impact To Patient

  MAUDE report 9289592 ↗
• MalfunctionJul 8, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ISOLATION TECHNIQUE COIL EMBOLIZATION PROCEDURE TARGETING A LESION AT THE LOWER PANCREATICODUODENAL ARTERY, THE EXCELSIOR® 1018® MICROCATHETER (STRYKER) APPROACHED THE TARGET LESION AND THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / L15213) WAS INTRODUCED BUT THE COIL COULD NOT BE ANCHORED. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL FOR LATER USE, BUT THE INTRODUCER SHEATH BECAME DAMAGED AND THE COIL COULD NOT BE RESHEATHED. IT WAS REPORTED THAT EXCESSIVE FORCE WAS NOT APPLIED DURING THE RESHEATHING ATTEMPT. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE DEVICES ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8769716 ↗