DELTAFILL DLF181650Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886704077145), received between May 15, 2017 and Mar 26, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Stretched; 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). THE PROCEDURE WAS PERFORMED USING THE TRIPLE COAXIAL TECHNIQUE WITH LEONIS HF AND BREAKTHROUGH. CONTINUOUS FLUSHING WAS MAINTAINED, BUT WHEN ATTEMPTING TO DELIVER THE DELTAFILL18 18 16MM X 50CM (PRODUCT CODE: DLF181650, LOT NUMBER 2952502S) INTO THE MICROCATHETER, STRONG RESISTANCE WAS ENCOUNTERED, AND THE COIL ALONG WITH BREAKTHROUGH MICROCATHETER (MC) WERE WITHDRAWN FROM THE PATIENT¿S BODY AS A SINGLE UNIT. VISUAL INSPECTION CONFIRMED AN UNRAVELING OF THE DELTAFILL18 18 16MM X 50CM, SO IT WAS REPLACED WITH FRAMES WHICH WAS IMPLANTED. THE PROCEDURE WAS CONTINUED WITH SMALLER SIZED COILS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE LEONISMOVA INTERMEDIATE CATHETER, ENPOWER CABLE, AND BREAKTHROUGH MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-MAR-2026 INDICATED THAT COIL UNRAVELING OCCURRED WHILE THE ADJUNCTIVE CATHETER STILL CONTAINED THE COIL, ALTHOUGH MOST OF THE COIL REMAINED INSIDE THE ANEURYSM. THE PHYSICIAN COMMENTED THAT HE FELT AS IF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698510 ↗
• MalfunctionOct 17, 2025Material Rupture; Stretched; Positioning Problem; Material Rupture; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A RENAL ARTERY ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE. THE APPROACH TO THE TARGET SITE WAS MADE VIA DOUBLE CATHETER TECHNIQUE. A PARENT PLUS 45 AND A 2.4 FR LEONIS MOVA MICROCATHETER (SB-KAWASUMI LABORATORIES), 5 FR ANGIOGRAPHIC CATHETER AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC) WERE USED. TWO OF THE MICROCATHETERS WERE ADVANCED INSIDE THE ANEURYSM. THE FRAMING WAS PERFORMED VIA THE LEONIS MOVA USING AN 18MM MICRUSFRAME AND A 16MM MICRUSFRAME. THEN AN ATTEMPT WAS MADE TO PLACE A 16MM X 50CM DELTAFILL 18 (DLF181650 / 1952542S) IN THE ANEURYSM. THE 16MM X 50CM DELTAFILL 18 COIL WAS INSERTED INTO THE MICROCATHETER, BUT IT COULD NOT BE ADVANCED FURTHER DUE TO RESISTANCE. THE INTRODUCER BECAME SPLIT, AND THE DELIVERY WIRE PROTRUDED FROM THE INTRODUCER SHEATH. WHEN THE COIL WAS WITHDRAWN FROM THE MICROCATHETER, IT WAS OBSERVED TO HAVE BECOME UNRAVELED. IT WAS REPLACED WITH A NEW COIL OF THE SAME SIZE (16MM X 50CM). SUBSEQUENTLY, A TOTAL OF 11 COILS INCLUDING COILS FROM OTHER MANUFACTURERS WERE USED AND NO SIMILAR ISSUE OCCURRED. THE 3MM X 12CM D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325365 ↗
• MalfunctionAug 14, 2023Break; Positioning Problem; Break; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A SPLENIC ARTERY ANEURYSM, AFTER THE UNSPECIFIED GUIDING CATHETER WAS ADVANCED FROM THE RIGHT COMMON ILIAC ARTERY TO THE COMMON HEPATIC ARTERY, A PROWLER SELECT PLUS MICROCATHETER (PRODUCT, LOT NUMBER UNKNOWN) WAS INSERTED INTO THE SPLENIC ARTERY AND COIL EMBOLIZATION WAS INITIATED. SEVERAL FRAMES AND DELTA COILS WERE PLACED, AND THEN THE ISSUE OCCURRED WHILE USING THE DELTAFILL18_16X50 COIL. THE MICROCATHETER KICKED BACK, SO ATTEMPTED TO RETRIEVE THE DELTAFILL18_16X50 COIL, BUT THE SHEATH GOT DAMAGED AND COULD NOT BE RE-SHEATHED. REPLACED WITH ANOTHER COIL WITH THE SAME PRODUCT CODE AND SUCCESSFULLY IMPLANTED. A TOTAL 10 SPECTRA COILS WERE USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO NECK REMODELING WAS UTILIZED. BASED ON THE PHOTO ANALYSIS OF THE DELTAFILL18 16MM X 50CM, THE COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17543435 ↗
• MalfunctionJul 14, 2022Material Rupture; Material Rupture

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION WITH THE TARGET AT THE INTERNAL ILIAC ARTERY DURING A STENT GRAFT PROCEDURE, SPECTRA COIL WERE USED; TWO 16MM FRAMING COILS WERE USED BEFORE THE COMPLAINT COIL, A 16MM X 50CM DELTAFILL 18 (DLF181650 / 30729886) WAS USED. THE COIL DELIVERY VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS PERFORMED AS PER THE INSTRUCTION FOR USE (IFU). HOWEVER; THE SHEATH GOT SEPARATED FROM THE POSITION WHERE THE COIL WAS RETAINED AND THE COIL CAME OUT FROM THERE. THE COMPLAINT COIL COULD NOT BE DELIVERED. ANOTHER COIL OF THE SAME SIZE WAS USED. CONTINUOUS FLUSH WAS NOT MAINTAINED. IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 INDICATED THAT THERE WAS NO RESISTANCE EXPERIENCED DURING THE PROCEDURE. THE MICROCATHETER WAS NOT REMOVED WHEN THE COMPLAINT COIL WAS RETRACTED AND REPLACED. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15024031 ↗
• InjuryMay 5, 2022Stretched; Positioning Problem; Stretched; Positioning Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COIL EMBOLIZATION OF A LEFT TRANSVERSE-SIGMOID (TS) SINUS DURAL ARTERIOVENOUS FISTULA (D-AVF), A 16MM X 50CM DELTAFILL18 (DLF181650/30729886) WAS SELECTED FOR USE AS THE 13TH COIL, BUT THE COIL DID NOT MAKE A SHAPE AS THE PHYSICIAN INTENDED. THEREFORE, THE COIL WAS ATTEMPTED TO BE RE-SHEATHED, BUT THE PROXIMAL PORTION OF THE COIL BECAME UNRAVELED. THE COMPLAINT DEVICE WAS THEN PULLED BACK WITH THE CONCOMITANT HEADWAY 21 MICROCATHETER (MICROVENTION) AS A UNIT, BUT ONLY THE MICROCATHETER KICKED BACK FROM THE TARGET LESION. SINCE THE COIL TAIL HAD BEEN IN THE SOFIA FLOW SELECT DISTAL ACCESS CATHETER (DAC) (MICROVENTION), THE PHYSICIAN WAS ABLE TO REMOVE THE COMPLAINT DEVICE USING A GOOSE NECK SNARE (MEDTRONIC). EMBOLIZATION OF THE TARGET LESION WAS COMPLETED, AND THE PROCEDURE WAS TERMINATED. THERE WAS NO REPORT OF PATIENT INJURY. DETAILS OF THE PROCEDURE: TRANSVENOUS APPROACH WAS USED FOR THE PROCEDURE. APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY (FA) WITH A 4F SHEATH (BRAND/MANUFACTURER NOT SPECIFIED). AN ANGIO CATHETER (SIZE/BRAND/MANUFACTURER NOT SPECIFIED) WAS ADVANCED TOWARDS THE LEFT COMMON CAROTID ARTERY (CCA). THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286934 ↗
• MalfunctionMar 18, 2020Unraveled Material; Unraveled Material

  AS REPORTED BY HEALTHCARE PROFESSIONAL, DURING A COIL L EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, A CONCOMITANT MICROCATHETER WAS INSERTED INTO THE PATIENT AND ADVANCED. AN EMBOLIZATION STARTED WITH A PENUMBRA COIL. A COIL (TARGETXXL, STRYKER) AND A DELTA COIL WERE USED. THE COMPLAINT COIL, A 16MM X 50CM DELTAFILL18 COIL (DLF181650, L12778) WAS USED BUT IT GOT STUCK AFTER IT CAME OUT A LITTLE FROM THE MICROCATHETER. THE PHYSICIAN REMOVED THE COMPLAINT COIL FROM THE PATIENT TO AVOID UNRAVELING. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE COIL BECAME UNRAVELED ¿A LITTLE AFTER BEING REMOVED FROM THE PATIENT¿. IT WAS REPLACED WITH ANOTHER COIL (COMPETITIVE PRODUCT) AND IT WAS USED WITH THE SAME MICROCATHETER WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY REPORTED. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. PRE-SHIPMENT PICTURES OF THE DEVICE WERE RECEIVED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849041 ↗
• MalfunctionDec 23, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN INHERENT HEPATIC ANEURYSM, AFTER INSERTING AND IMPLANTING TWO 20MM X 50CM MICRUSFRAME 18 COILS AND THREE 18MM X 50CM TARGET XXL COILS, THE 16MM X 50CM DELTAFILL 18 COIL (DLF181650 / S12981) COIL WAS USED, BUT THE LIGHTHOUSE MICROCATHETER (PIOLAX MEDICAL DEVICES) KICKED BACK AND THE COIL WAS RE-SHEATHED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH THE MICROCATHETER CONTINUOUSLY FLUSHED, THE DELIVERY WIRE WAS RETRACTED WITHOUT ANY FRICTION BUT THE COIL BECAME UNRAVELED. THE COIL WAS REMOVED, AND THE PROCEDURE WAS CONCLUDED AND CONSIDERED COMPLETED AS IT WAS. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511573 ↗
• MalfunctionNov 11, 2019Unraveled Material; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM FOR TYPE II ENDOLEAK, A 16MM X 50CM DELTAFILL18 COIL (DLF181650, S12574) WAS RE-SHEATHED SEVERAL TIMES BUT THE COIL UNRAVELED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. 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 9304061 ↗
• MalfunctionDec 6, 2018Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE TYPE II ENDOLEAK COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM AT THE INTERNAL MESENTERIC ARTERY, ACCESSING FROM THE RIGHT FEMORAL ARTERY APPROACHING FROM THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA). THE CATHETER WAS ADVANCED THROUGH THE SMA TO THE TARGET LESION AT THE IMA. THE COILING PORTION OF THE PROCEDURE STARTED WITH THE PROGREAT ALPHA¿ (TERUMO) PERIPHERAL MICROCATHETER AND THE SEVEN (7) DELTAFILL 18 COILS WERE IMPLANTED AT THE TARGET LESION. WHEN THE 8TH DELTAFILL 18 16MM X 50CM COIL (DLF181650 / L13397) WAS INSERTED, THE COIL DID NOT COMPLETELY COME OUT OF THE DISTAL END OF THE MICROCATHETER. THERE WAS RESISTANCE BETWEEN THE MICROCATHETER AND THE DELIVERY WIRE. THE PHYSICIAN DECIDED TO RESHEATH THE COIL AND THE COIL BECAME PREMATURELY DEPLOYED INSIDE THE MICROCATHETER. THE PHYSICIAN USED THE DELIVERY WIRE AND THE GUIDEWIRE (CHIKAI, ASAHI INTECC) TO PUSH THE PREMATURELY DEPLOYED COIL INSIDE THE MICROCATHETER IN ATTEMPT TO GET THE COIL IMPLANTED, BUT THE COIL REMAINED INSIDE THE MICROCATHETER AND THE PHYSICIAN HAD TO WITHDRAW THE MICROCATHETER WITH THE PREMATURELY DEPLOYED DELTAFILL 18 IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139827 ↗
• MalfunctionOct 1, 2018Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ABDOMINAL ANEURYSM, THE DELTAFILL 18 16MM X 50CM COIL (DLF181650 / L11869) WAS USED AND IT PREMATURELY DETACHED DURING PLACEMENT WITH 3 CM OF THE COIL STILL OUTSIDE OF THE ANEURYSM; THE REMAINING 3 CM OF THE COIL WAS PUSHED INTO THE ANEURYSM AND THE PROCEDURE WAS COMPLETED. THE COIL WAS IMPLANTED. THERE WAS NO FURTHER ISSUE AND THERE WAS NO PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUE. 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 NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923107 ↗
• MalfunctionAug 15, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE AT THE INTERNAL ILIAC ARTERY (IIA), THE DELTAFILL 18 16 MM X 50 CM COIL (DLF181650 / S12208) WAS THE 7TH COIL CHOSEN; WHEN THE COIL WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED THAT THE COIL WAS HAD PROTRUDED FROM THE SHEATH INTRODUCER. IT WAS CONFIRMED THAT EXCESSIVE FORCE WAS NOT USED DURING THE HANDLING OF THE COIL. THE DELTAFILL COIL WAS REPLACED WITH ANOTHER FROM A DIFFERENT LOT NUMBER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE DELTAFILL 18 COIL WAS RETURNED FOR EVALUATION; THE PRESCORE RUPTURE REPORTED WAS CONFIRMED. IN ADDITION, THE EMBOLIC COIL WAS OBSERVED TO BE KINKED WHERE IT PASSES INTO THE COIL INTRODUCER AT THE SHORT, SHEATHED SEGMENT. THIS INVESTIGATIONAL FINDING MEETS FDA REPORTING CRITERIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7786897 ↗
• MalfunctionMar 13, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAFILL 18 COIL ((B)(4)) COULD NOT BE DETACHED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR EVAR AT THE IIA. IT WAS REPORTED THAT AN ENERGIZATION FAILURE OCCURRED. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER ONE. THE PATIENT WAS A (B)(6)-YEAR-OLD MALE WHOSE VESSEL WAS NOT TORTUROUS AND NOT CALCIFIED. A DCB ((B)(4)), MICROCATHETER (PROWLER SELECT PLUS), AND AN ENPOWER WERE ALSO USED FOR THIS PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY/COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7334330 ↗
• MalfunctionNov 15, 2017Difficult To Position; Unraveled Material; Difficult To Position; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A RENAL ARTERY ANEURYSM, A DELTAFILL18 (DLF181855/ S13264) WAS INSERTED INTO THE CARRY LEON MICROCATHETER, AND SOME RESISTANCE FELT AT THE MIDDLE PART OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO INSERT IT WITH SOME FORCE, AND THE DELIVERY WIRE CAME OFF FROM THE SHEATH INTRODUCER AND WAS EXPOSED. THEREFORE, IT WAS REPLACED WITH ANOTHER DELTAFILL18 (DLF181855/ LOT S13264). HOWEVER, THERE WAS SOME RESISTANCE FELT WITH THE MICROCATHETER AND THE DELIVERY WIRE CAME OFF FROM THE SHEATH INTRODUCER AND EXPOSED AGAIN. THEN, THE MICRO CATHETER WAS REPLACED WITH THE PROWLER SELECT PLUS (606S255FX/LOT UNK) AND THE PROCEDURE CONTINUED. A COIL (16MM DELTAFILL) WAS IMPLANTED WITHOUT ANY ISSUE, AND THE DELTAFILL18 (DLF181650/ LOT S13345) WAS INSERTED INTO THE MICROCATHETER; HOWEVER, THERE WAS RESISTANCE FELT AND IT WAS REMOVED FROM THE PATIENT. AFTER REMOVAL, IT WAS HANDLED TO SEE IF THE MICROCOIL COULD FUNCTION AND THE WIRE CAME OFF FROM THE SHEATH INTRODUCER AND EXPOSED THE DPU/COIL. IT WAS REPLACED WITH ANOTHER DELTAFILL18 (DLF181650/ LOT S13345), BUT IT GOT STUCK AT THE MIDDLE PART OF THE MICROCATHETER AND COULD NOT BE I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7033072 ↗
• MalfunctionMay 15, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT A DELTAFILL18 16 MM X 50 CM (DLF181650/C41787) FAILED TO DETACH. THE COIL WAS REMOVED IN ITS ENTIRETY AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WERE NO DAMAGES NOTED ON THE COIL OR THE COIL DELIVERY SYSTEM PRIOR TO USE OR UPON REMOVAL; THE COIL WAS NOT STRETCHED WHEN REMOVED FROM THE PATIENT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND ALL LIGHTS HAD ILLUMINATED WHEN THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT HAD ILLUMINATED AND THE AUDIBLE SIGNAL HAD BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME ENPOWER CONNECTING CABLE AND ENPOWER DCB WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE PROCEDURE WAS COMPLETED USING OTHER COILS (UNKNOWN). THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS RELATED TO DEVICE OR REPORTED EVENT. THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567563 ↗