DELTAFILL DLF180835Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886704077220), received between Nov 29, 2016 and Apr 9, 2026 — classified as 1 injury, 21 malfunctions.

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

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Device Difficult to Setup or Prepare; Stretched; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF THE SPLENIC ARTERY ANEURYSM, THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS STRONG RESISTANCE WAS FELT WITH A DELTA FILL 18 DELTA FILL 18 X 35CM (PRODUCT CODE: DLF180835, LOT NUMBER: 2592511S) WHICH WAS USED AS THE FIFTH COIL. THE COIL ATTEMPTED TO BE RE-SHEATHED, BUT COULD NOT. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-APR-2026 INDICATED THAT THE INTRODUCER WAS NOT DAMAGED IN ANY WAY. THE EMBOLIC OIL WAS UNRAVELED. THERE WAS NO EXCESSIVE FORCE DURING UNSHEATHING OR RE-SHEATHING. THERE WAS NO DIFFICULTIES PREPPING THE DELIVERY SYSTEM. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY WIRE WHEN REMOVED FROM THE PATIENT AND WAS PARTIALLY UNRAVELED. THE UNRUPTURED ANEURYSM MEASURED 18¿19 MM IN DIAMETER AND HAD A WIDE NECK. THEREFORE, THE MICROCATHETER HAD TO BE DEEPLY ENGAGED, MAKING THE SITUATION DIFFICULT TO ASSESS, SUCH AS WHETHER THE INTERMEDIATE CATHETER WAS PROTRUDING BEYOND THE MICROCATHETER TIP. AS A RESULT, THE COIL WAS LIKELY UNDER TENSION AT THE MICROCATHETER TIP, AND THE PHYSICIAN COULD NOT IMMEDIATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833062 ↗
• MalfunctionApr 6, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT UPON OPENING THE PACKAGE OF DELTAFILL18 COIL (PRODUCT CODE: DLF180835, LOT NUMBER 2232558S) THE DELIVERY WIRE AND SHEATH WERE FOUND TO BE TORN, RENDERING THE DEVICE UNUSABLE. THE DEVICE WAS DISCARDED. THERE WAS NO VISIBLE DAMAGE TO THE OUTER BOX OR OTHER PACKAGING. THE DELTAFILL18 WAS REPLACED WITH ANOTHER NEW DEVICE OF THE SAME SPECIFICATION, WHICH WAS SUCCESSFULLY IMPLANTED. PATIENT IMPACT: NO ADVERSE EVENTS OR NEGATIVE CLINICAL IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790672 ↗
• MalfunctionDec 11, 2024Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF THE INTERCOSTAL ARTERY TO TREAT A PEDIATRIC MAJOR AORTOPULMONARY COLLATERAL ARTERY, THE PHYSICIAN WHO USES THE 8MM X 35CM DELTAFILL 18 (DLF180835) ON A REGULAR BASIS, THERE WERE NO PROBLEMS WITH THE PREPARATION. AS THE SIZE OF THE 8MM X 35CM DELTAFILL 18 (DLF180835 / 31178133) WAS USED RELATIVELY OFTEN, THERE DID NOT SEEN TO BE ANYTHING UNUSUAL. HOWEVER, ALTHOUGH THE ALTHOUGH THE DELTAFILL 18 WAS SUPPOSED TO HAVE AN 8MM MEMORY, IT DID NOT FORM A LOOP INSIDE THE PATIENT¿S BODY, MAKING IT DIFFICULT TO PLACE, AND THE ¿COIL'S BEHAVIOR WAS FELT STRANGE. SO THE 8MM X 35CM DELTAFILL 18 WAS RETRIEVED, AND THE PROCEDURE WAS CONTINUED WITH A PRODUCT FROM [A COMPETITOR]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PROBLEMS. THE PHYSICIAN COMMENTED THAT THE ISSUE ¿IS THOUGHT TO BE A CAUSE ON THE COIL GIVEN THAT THE SECOND HALF OF THE LOOP STOPPED WINDING AT ALL, AND THAT SINCE THE DELTAFILL 18 IS USED ON A REGULAR BASIS, THE BEHAVIOR IS UNDERSTOOD IN DETAIL.¿ A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CONCOMITANT LEONIS MOVA¿ MICROCATHETER (SUMIMOTO BAKELITE). THERE WAS NO NEGATIVE IMPACT TO THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909864 ↗
• MalfunctionJul 31, 2023Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION FOR A PULMONARY ARTERIOVENOUS MALFORMATION (AVM), A CARRY LEÓN MICROCATHETER (UTM) WAS INSERTED INTO A BALLOON CATHETER (UNSPECIFIED BRAND) AND THE COIL EMBOLIZATION WAS INITIATED FROM THE SAC TO THE PROXIMAL VESSEL. DURING THE ATTEMPT TO IMPLANT THE FIRST COIL, AN 8MM X 35CM DELTAFILL 18 (DLF180835 / 30677915), IT WAS REWOUND SEVERAL TIMES AND BECAME PREMATURELY DETACHED INSIDE THE MICROCATHETER. DUE TO THE COIL DETACHING INSIDE THE MICROCATHETER, THE ENTIRE SYSTEM WAS RETRIEVED AND REMOVED. THE COIL WAS TAKEN OUT AND IT WAS REPLACED WITH ANOTHER 8MM X 35CM DELTAFILL 18 AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ONLY THE COIL IS AVAILABLE TO BE RETURNED; THE DELIVERY WIRE WAS REPORTEDLY LOST AND COULD NOT BE RECOVERED FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431277 ↗
• MalfunctionApr 21, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ABDOMINAL STENT GRAFTING AND ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH THE TARGET ON THE INTERNAL ILIAC ARTERY (IIA) AND INFERIOR MESENTERY ARTERY (IMA), A CARRY LEÓN MICROCATHETER (UTM) WAS ADVANCED TO THE TARGET LESION USING A ¿COBRA-SHAPED PARENT CATHETER.¿ THE COMPLAINT COIL, A 8MM X 35CM DELTAFILL 18 (DLF180835 / 30915606) COULD NOT BE DETACHED DURING THE EMBOLIZATION OF THE IIA. IT WAS REPORTED THAT THE POWER DISTRIBUTION HAD BEEN CHECKED AT THE BEGINNING OF THE PROCEDURE. WHEN THE DELTAFILL COIL WAS RECONNECTED PRIOR TO DETACHING, IT WAS REPORTED THAT THERE WAS NO RESPONSE. AFTER REPLACING THE ENPOWER CONTROL CABLE (ECB00018200 / 30975218) AND THE DETACHMENT CONTROL BOX, THE ISSUE CONTINUED. ANOTHER DELTAFILL COIL WAS USED AND IT WAS SUCCESSFULLY DETACHED. AFTER THAT, WHEN A 4MM X 12CM GALAXY G3 (GLY120412 / 30792966) WAS ABOUT TO BE USED FOR THE IMA, THE SAME DETACHMENT ISSUE ALSO OCCURRED. HOWEVER, THE 4MM X 12CM GALAXY G3 COIL DID NOT RESPOND TO POWER DISTRIBUTION PRIOR TO USE, IT WAS NOT USED. IT WAS REPORTED THAT ANOTHER COIL WAS USED IN PLACE OF THE 4MM X 12CM GALAXY G3. IT WAS NOT KNOWN IF CONTINUOUS FLUSH W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792418 ↗
• MalfunctionOct 1, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PREOPERATIVE COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY (IIA), A CONTRALATERAL APPROACH WAS MADE. A MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS) WAS APPROACHED AND ONE OF THE COMPLAINT COILS, A 14MM X 45CM DELTAFILL 18 (DLF181445 / 30494377) GOT STUCK IN THE MICROCATHETER DURING COIL EMBOLIZATION. THE PHYSICIAN ATTEMPTED TO RE-SHEATH BUT THE RE-SHEATHING WAS NOT POSSIBLE. ¿SOME NEW COILS WERE USED FOR EMBOLIZATION.¿ ANOTHER COMPLAINT COIL, AN 8MM X 35CM DELTAFILL 18 (DLF180835 / 30715039) WAS USED BUT ¿DETACHMENT WAS IMPOSSIBLE.¿ THE ENPOWER CONTROL CABLE (ECB00018200 / 30711340) WAS REPLACED WITH ANOTHER CABLE BUT THE COIL WAS STILL UNABLE TO BE DETACHED. THE 8MM X 35CM DELTAFILL 18 WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526048 ↗
• MalfunctionMay 4, 2022Break; Positioning Problem; Break; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) COIL EMBOLIZATION PROCEDURE AT THE INFERIOR MESENTERIC ARTERY (IMA), A CONCOMITANT PROWLER SELECT PLUS MICROCATHETER WAS INDUCED TO THE TARGET LESION AFTER THE PARENT CATHETER WAS INTRODUCED INTO THE IMA. THEN THE 7MM X 17CM MICRUSFRAME 14 COIL (MFR140717 / 30362732) WAS USED. THE PHYSICIAN ATTEMPTED TO MAKE A FRAME BUT THE MICRUSFRAME WAS NOT ABLE TO MAKE THE SHAPE AS THE PHYSICIAN INTENDED. THE MICRUSFRAME WAS RESHEATHED. THEN THE 8MM X 35CM DELTAFILL 18 COIL (DLF180835 / 30464336) WAS USED, BUT IT WAS ALSO RESHEATHED BECAUSE IT WAS NOT ABLE TO MAKE THE SHAPE AS THE PHYSICIAN INTENDED. THE SIZE OF THE COIL WAS CHANGED WITH A SMALLER COIL AND OTHER COILS WERE USED AND THE FRAMING WAS SUCCESSFULLY COMPLETED. AFTER THE SUCCESSFUL FRAMING, THE RESHEATHED 7MM X 17CM MICRUSFRAME 14 AND 8MM X 35CM DELTAFILL 18 WERE USED, BUT THEY WERE REMOVED FROM THE PATIENT¿S BODY BECAUSE THE SHEATHS ON THESE COILS WERE DAMAGED AND NOT ABLE TO BE GUIDED. COIL EMBOLIZATION WAS PERFORMED WITH OTHER COILS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. CONTINUOUS FLUSH WAS MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274583 ↗
• MalfunctionMay 4, 2022Break; Positioning Problem; Break; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED 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 14274491 ↗
• MalfunctionApr 11, 2022Break; Difficult to Advance; Break; 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. ONE OF THE COMPLAINT COILS, AN 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. AFTER THE IMPLANTATION OF THE REPLACEMENT COIL, A 6MM X 25CM DELTAFILL 18 (DLF180625 / 30585432) WAS BEING DELIVERED, BUT THERE WAS RESISTANCE FELT. IT 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 35

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079482 ↗
• 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 (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 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 13203942 ↗
• MalfunctionJul 29, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION WITH THE TARGET AT THE INFERIOR MESENTERIC ARTERY (IMA), THE CONCOMITANT MICROCATHETER WAS ADVANCED TOWARD THE LESION, THE PHYSICIAN THEN ATTEMPTED TO USE THE 8MM X 35CM DELTAFILL 18 COIL (DLF180835 / K10117), BUT THE COMPLAINT COIL WAS BROKEN AND THE COIL BECAME PROTRUDED FROM THE DISTAL END OF THE SHEATH EVEN THOUGH THE PHYSICIAN DID NOT PUSH IT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND THE REPLACEMENT COIL WAS IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE REPORTED EVENT DID NOT RESULT ANY PROCEDURAL DELAY OR PROLONGATION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341441 ↗
• MalfunctionApr 28, 2020Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY, AN 8MM X 35CM DELTAFILL18 COIL (DLF180835, L17164) WAS INSERTED AND ADVANCED FOR FILLING. HOWEVER, THE SHEATH INTRODUCER GOT DAMAGED WHEN IT WAS ATTEMPTED TO BE PEELED AWAY. IT WAS NOT ABLE TO BE RE-SHEATHED. OTHER FOUR COILS WERE USED WITHOUT ANY PROBLEMS. NO EXCESSIVE FORCE HAD BEEN APPLIED TO ATTEMPT TO UN-ZIP OR RE-ZIP THE INTRODUCER. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005838 ↗
• MalfunctionApr 14, 2020Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR ANEURYSM REPAIR (EVAR) COIL EMBOLIZATION, THE 8MM X 35CM DELTAFILL 18 COIL (DLF180835 / L16676) WAS INSERTED INTO THE PROGREAT® ALPHA MICROCATHETER (TERUMO), BUT THERE WAS A LITTLE RESISTANCE ENCOUNTERED. THE COIL BECAME SEPARATED BETWEEN THE DELIVERY WIRE AND THE COIL DURING THE ADVANCEMENT AND RETRACTION IN THE ATTEMPT TO OVERCOME THE RESISTANCE. THE COIL AND THE CONCOMITANT MICROCATHETER WERE REMOVED TOGETHER. THE SEPARATED COIL PART WAS FLUSHED WITH CONTRAST MEDIA AND REMOVED AND REINSERTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN USED THE COIL IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959202 ↗
• MalfunctionApr 3, 2020Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 8MM X 35CM DELTAFILL18 (DLF180835, L16796) COIL WAS IMPLANTED AT THE LESION AND IT WAS ATTEMPTED TO BE DETACHED WITH AN ENPOWERCONTROLCABLE (L16610). HOWEVER, THE COMPLAINT COIL WAS NOT ABLE TO BE DETACHED. THE PHYSICIAN TRIED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. THE USER ATTEMPTED TO RE-SHEATH IT, HOWEVER, THE SHEATH INTRODUCER GOT SPLIT AND IT WAS NOT ABLE TO BE RE-SHEATHED. THERE WAS NO REPORTED PATIENT INJURY. BEFORE USING THE COMPLAINT COIL, TWO COILS WERE DETACHED WITH THE SAME CABLE. THE FIRST DELTAFILL COIL (LOT NUMBER: L16351) WAS DETACHED WITH THE CABLE BEFORE THE COMPLAINT COIL WAS USED. THERE WAS ALSO DIFFICULTIES DETACHING THE SECOND COIL, A 8MM X 35CM DELTAFILL18 (DLF180835, L16796) BUT IT DETACHED AFTER THE DELIVERY WIRE WAS RETRACTED A LITTLE. PRE-SHIPMENT PICTURE OF THE COIL WAS PROVIDED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9922334 ↗
• MalfunctionApr 3, 2020Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 8MM X 35CM DELTAFILL18 (DLF180835, L16796) COIL WAS IMPLANTED AT THE LESION AND IT WAS ATTEMPTED TO BE DETACHED WITH AN ENPOWERCONTROLCABLE (L16610). HOWEVER, THE COMPLAINT COIL WAS NOT ABLE TO BE DETACHED. THE PHYSICIAN TRIED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. THE USER ATTEMPTED TO RE-SHEATH IT, HOWEVER, THE SHEATH INTRODUCER GOT SPLIT AND IT WAS NOT ABLE TO BE RE-SHEATHED. THERE WAS NO REPORTED PATIENT INJURY. BEFORE USING THE COMPLAINT COIL, TWO COILS WERE DETACHED WITH THE SAME CABLE. THE FIRST DELTAFILL COIL (LOT NUMBER: L16351) WAS DETACHED WITH THE CABLE BEFORE THE COMPLAINT COIL WAS USED. THERE WAS ALSO DIFFICULTIES DETACHING THE SECOND COIL, A 8MM X 35CM DELTAFILL18 (DLF180835, L16796) BUT IT DETACHED AFTER THE DELIVERY WIRE WAS RETRACTED A LITTLE. PRE-SHIPMENT PICTURE OF THE COIL WAS PROVIDED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9921886 ↗
• MalfunctionDec 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AN INTERNAL ILIAC ARTERY, THERE WAS STRONG RESISTANCE FELT BETWEEN THE DISTAL END OF A 8MM X 30CM MICRUSFRAME18 (MFR180830, S14023) AND A 8MM X 35CM DELTAFILL18 (DLF180835, S13515) WITH A COILING SUPPORT MICROCATHETER (MC). THE COMPLAINT COILS WERE NOT ABLE TO BE DELIVERED TO THE LESION. THE PHYSICIAN FLUSHED INSIDE THE MICROCATHETER AND THE DISTAL END OF THE COILS BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COILS WERE REPLACED WITH ANOTHER COIL (SAME CATALOG NUMBER) AND THE PROCEDURE WAS COMPLETED. SEVEN COILS WERE USED. PICTURES WERE RECEIVED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PICTURED WERE RECEIVED OF THE DEVICES. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT WHILE ADVANCING THE COIL DELIVERY SYSTEMS THROUGH THE CONCOMITANT MICROCATHETER, THE COIL PREMATURELY DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9473352 ↗
• MalfunctionDec 3, 2019Separation Failure; Separation Failure

  AS REPORTED BY HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE INTERNAL ILIAC ARTERY, THE PHYSICIAN ATTEMPTED TO DETACH A 8MM X 35CM DELTAFILL18 COIL (DLF180835, L14543) BUT IT WAS NOT ABLE TO BE DETACHED WHEN USING A ENPOWER CONTROL CABLE (ECB00018200,L16081). THE BATTERY OF A CONTROL BOX WAS FULL, THE GREEN SYSTEM READY LIGHT ILLUMINATED, AND THE BEEP SOUND WAS HEARD AS USUAL. THE DETACHMENT BUTTON WAS DEPRESSED THREE TIMES, BUT THE SAME ISSUE CONTINUED. THE COMPLAINT CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE CONTINUED. THE SECOND CABLE DID NOT SUCCESSFULLY DETACH THE COIL. THE PHYSICIAN REPLACED THE COMPLAINT COIL WITH ANOTHER COIL AND IT DETACHED, THERE WAS NO REPORT OF PATIENT INJURY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401167 ↗
• MalfunctionNov 14, 2019Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL ILIAC ARTERY, THERE WAS A HEAVY RESISTANCE FELT BETWEEN A 8MM X 35CM DELTAFILL18 COIL (DLF180835, L11490) AND THE NON-SPECIFIC MICROCATHETER (MC) WHEN DELIVERY. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZE COIL, AND IT WAS IMPLANTED. THE PROCEDURE COMPLETED SAFELY. OTHER SPECTRA COILS WERE USED SAFELY AND IMPLANTED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE ANALYSIS OF THE DELTAFILL18 COIL (DLF180835, L11490), THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324370 ↗
• MalfunctionJan 29, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM FOR A PRE-STENT GRAFT AT THE INTERNAL ILIAC ARTERY, THE 8 MM X 35 CM DELTAFILL 18 COIL (DLF180835 / L12821) WAS THE FOURTH COIL USED. THE DELTAFILL 18 COIL DID NOT DETACH WITH THE ENPOWER CONTROL CABLE (ECB00018200 / L12420); THE ENPOWER CONTROL CABLE WAS REPLACED WITH ANOTHER FROM THE SAME LOT (L12420) AND THE SAME ISSUE WAS EXPERIENCED. THE COIL DID NOT DETACH. IMAGING WAS TAKEN, AND IT WAS CONFIRMED THAT THE ANEURYSM WAS SUFFICIENTLY EMBOLIZED SO ADDITIONAL COILS WERE NOT USED. THE PROCEDURE WAS COMPLETED WITHOUT 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. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT IS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287252 ↗
• MalfunctionJul 23, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE OF A 9MM ANEURYSM AT THE INTERNAL CAROTID C3 SEGMENT, A GUIDING CATHETER AND THE MICROCATHETER WERE INSERTED FROM THE RIGHT FEMORAL ARTERY AND ADVANCED TO THE LESION. THE DELTAFILL 18 8MM X 35CM COIL (DLF180835 / S12417) WAS INSERTED AND IT WAS FOUND THAT THE COIL DID NOT FIT THE LESION; THE DELTAFILL COIL WAS REMOVED AND IT BECAME UNRAVELED IN THE MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE 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. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE DELTAFILL COIL WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712932 ↗
• MalfunctionOct 25, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A TYPE 2 ENDOLEAK AT THE INTERNAL ILIAC ARTERY, A DELTAFILL18 (DLF180835/ S12542) FAILED TO DETACH WITH AN ENPOWER CONTROL CABLE (ECB00018200/ S13420). THE COMPLAINT DELTAFILL18 WAS USED AS THE FIRST MICRO COIL. THE COMPLAINT COIL WAS DELIVERED TO THE LESION AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. HOWEVER, IT COULD NOT BE DETACHED EVEN THOUGH THE DETACHMENT BUTTON WAS PRESSED. THE PHYSICIAN UNPLUGGED AND CONNECTED IT FOR SEVERAL TIMES, BUT THE ISSUE CONTINUED. THE COMPLAINT ENPOWER CONTROL CABLE WAS EXCHANGED, BUT IT COULD NOT DETACH THE COIL. THE GREEN SYSTEM READY LIGHT OF THE ENPOWER CONTROL CABLE ILLUMINATED IN THE BEGINNING. HOWEVER, AFTER IT WAS UNPLUGGED AND CONNECTED FOR SEVERAL TIMES, THE LIGHT DID NOT ILLUMINATE. THEREFORE, BOTH WERE REPLACED TO NEW PRODUCTS AND THE COIL EMBOLIZATION WAS COMPLETED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT CABLE. A PRE-DEPLOYMENT ELECTRICAL TEST HAD BEEN PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 10 MINUTES. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6977412 ↗
• MalfunctionNov 29, 2016Difficult To Position; Difficult To Position

  THE CONTACT AT THE HOSPITAL REPORTED THAT THE DELTAXSFT COIL (DLX100206/C41704) COULD NOT ADVANCE THROUGH THE MICROCATHETER AND THE DELTAFILL COIL (DLF180835/S11465) DID NOT OPTIMALLY CONFORM TO THE ANEURYSM. THE FIRST ANEURYSM WAS A RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) MEASURING 4MM. A STRYKER SL-10 MICROCATHETER WAS INSERTED AND THE DELTAXSFT COIL (DLX100206/C41704) WAS ATTEMPTED TO BE INSERTED AFTER FRAMING WITH TWO STRYKER TARGET COILS AT THE PCOM. PREP OF THE DELTAXSFT BEGAN WITH INSERTING THE GREEN INTRODUCER SHEATH INTO A BOWL OF NORMAL SALINE AND PUSHING THE COIL OUT INTO THE SALINE TO HYDRATE THE COIL THEN WITHDRAWING THE COIL BACK INTO THE SHEATH. THE INTRODUCER OF THE DELTAXSFT 2X6 WAS INSERTED INTO THE TOUHEY RHV AND HUBBED INTO THE SL-10 MICROCATHETER. UPON UNLOCKING THE PUSHER WIRE AND TRANSFERRING THE COIL INTO THE SL-10 THE PUSHER WIRE HUB-CONNECTOR WAS ROUGHLY 6 INCHES FROM MEETING THE RESHEATHING TOOL BEFORE THE DOCTOR COULD NO LONGER ADVANCE THE PUSHER WIRE. THE DOCTOR THEN HELD THE TRANSLUCENT SHEATH AND PUSHER WIRE AND ADVANCED THE RE-SHEATHING TOOL DOWN TO THE GREEN INTRODUCER THEN PULLED BOTH THE GREEN INTRODUCER AND RE-SHEATHING TOOL BACK TOWARD THE H

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6132366 ↗