DELTAXSFT DLX100206Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886704077336), received between Oct 25, 2017 and Apr 17, 2024 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Stretched” (12 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2024Break; Difficult to Remove; Premature Separation; Break; Difficult to Remove; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 2MM X 6CM COIL (DLX100206, 30921357) COULD NOT BE REMOVED FROM HOOP / STRONG RESISTANCE OCCURRED, SO PHYSICIAN DID NOT PULL ANY FURTHER. OTHER CNV COILS WERE USED TO FINISH THE PROCEDURE. BASED ON ADDITIONAL INFORMATION RECEIVED ON 10-APR-2024, THE COIL WAS SEPARATED FROM DPU, DPU WIRE APPEARED STRETCHED. THE REMAINDER OF THE COIL WILL BE RETURNED FOR INSPECTION. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126925 ↗
• InjuryFeb 11, 2022Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED PROBLEMS WITH THE DETACHMENT OF THE LAST COILS. IT WAS REPORTED THAT IT WAS KNOWN THAT ¿IT DOES NOT WORK THE FIRST TIME. BUT WITH THE LAST ONE, WE HAD SERIOUS PROBLEMS.¿ THE COILS WERE ONLY DETACHED AFTER SEVERAL (APPROXIMATELY 5 ¿ 6) DETACHMENT ATTEMPTS. THE COIL MARKER WAS DELIBERATELY MOVED WELL BEYOND THE SECOND MARKER OF THE MICROCATHETER TO PROMOTE DETACHMENT; EVEN THEN, IT WAS DETACHED ONLY AFTER SEVERAL ATTEMPTS. IN ADDITION, THE DETACHMENT OF ONE OF THE COILS OCCURRED ONLY AFTER RETRACTION WITHIN THE MICROCATHETER. THE COMPLAINT DOCUMENTED TWO (2) COILS IN THIS ORDER: A 2MM X 3CM DELTAXSFT 10 (DLX100203 / K10735) AND A 2MM X 6CM DELTAXSFT 10 (DLX100206 / 30399407). THE PROCEDURE WAS NOT DELAYED BY THE REPORTED ISSUE; IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2022. THE INFORMATION INDICATED THAT THE ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WAS ON (B)(6) 2022, AND IT WAS TARGETING A CIRCULATORY ELIMINATION OF A BROAD-BASED POLYLOBULATED RIGHT A1/A2 ANEURYSM WITH APICAL DAUGHTER ANEURYSM. BOTH COILS DETACHED ONLY MANY DETACHMENT ATTEMPTS WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518524 ↗
• MalfunctionDec 28, 2021Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT ALL THREE (3) 2MM X 6CM DELTAXSFT 10 COILS (DLX100206) FROM THE SAME LOT (30537004) COULD NOT BE PUSHED OUT OF THE INTRODUCER SHEATH. THE COILS WERE APPROPRIATELY FLUSHED. AFTER AN INCREASE IN PRESSURE TO ADVANCE THE COIL OUT OF THE INTRODUCER SHEATH, THE DELIVERY WIRE OF ONE OF THE COILS BECAME PROTRUDED FROM THE INTRODUCER SHEATH. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE CONCOMITANT EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER) AND LOCKED WITH THE ROTATING HEMOSTASIS (RHV) DURING THE DEVICE ADVANCEMENT. THE CONCOMITANT WAS MAINTAINED IN THE TARGET VESSEL. THE SAME MICROCATHETER WAS USED TO SUCCESSFULLY TREAT THE TARGET VESSEL WITH OTHER CERENOVUS COILS. IT WAS INDICATED THAT PUSHING FORCE HAD BEEN INCREASED WHEN RESISTANCE WAS FELT, BUT THE FORCE WAS NOT EXCESSIVE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 2MM X 6CM DELTAXSFT 10 COIL, THE EMBOLIC COIL WAS OBSERVED PROT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101676 ↗
• MalfunctionDec 28, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT ALL THREE (3) 2MM X 6CM DELTAXSFT 10 COILS (DLX100206) FROM THE SAME LOT (30537004) COULD NOT BE PUSHED OUT OF THE INTRODUCER SHEATH. THE COILS WERE APPROPRIATELY FLUSHED. AFTER AN INCREASE IN PRESSURE TO ADVANCE THE COIL OUT OF THE INTRODUCER SHEATH, THE DELIVERY WIRE OF ONE OF THE COILS BECAME PROTRUDED FROM THE INTRODUCER SHEATH. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE CONCOMITANT EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER) AND LOCKED WITH THE ROTATING HEMOSTASIS (RHV) DURING THE DEVICE ADVANCEMENT. THE CONCOMITANT WAS MAINTAINED IN THE TARGET VESSEL. THE SAME MICROCATHETER WAS USED TO SUCCESSFULLY TREAT THE TARGET VESSEL WITH OTHER CERENOVUS COILS. IT WAS INDICATED THAT PUSHING FORCE HAD BEEN INCREASED WHEN RESISTANCE WAS FELT, BUT THE FORCE WAS NOT EXCESSIVE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 2MM X 6CM DELTAXSFT 10 COIL, THE EMBOLIC COIL WAS OBSERVED PROT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101631 ↗
• MalfunctionDec 28, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT ALL THREE (3) 2MM X 6CM DELTAXSFT 10 COILS (DLX100206) FROM THE SAME LOT (30537004) COULD NOT BE PUSHED OUT OF THE INTRODUCER SHEATH. THE COILS WERE APPROPRIATELY FLUSHED. AFTER AN INCREASE IN PRESSURE TO ADVANCE THE COIL OUT OF THE INTRODUCER SHEATH, THE DELIVERY WIRE OF ONE OF THE COILS BECAME PROTRUDED FROM THE INTRODUCER SHEATH. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE CONCOMITANT EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER) AND LOCKED WITH THE ROTATING HEMOSTASIS (RHV) DURING THE DEVICE ADVANCEMENT. THE CONCOMITANT WAS MAINTAINED IN THE TARGET VESSEL. THE SAME MICROCATHETER WAS USED TO SUCCESSFULLY TREAT THE TARGET VESSEL WITH OTHER CERENOVUS COILS. IT WAS INDICATED THAT PUSHING FORCE HAD BEEN INCREASED WHEN RESISTANCE WAS FELT, BUT THE FORCE WAS NOT EXCESSIVE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 2MM X 6CM DELTAXSFT 10 COIL, THE EMBOLIC COIL WAS OBSERVED STUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101627 ↗
• MalfunctionOct 8, 2021Failure to Advance; Failure to Advance

  THIS COIL GOT STUCK IN THE MICROCATHETER WHILE ADVANCING INTO THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601387 ↗
• MalfunctionApr 29, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A SACCULAR ANEURYSM TO THE INTERNAL CAROTID ARTERY (ICA), A 2MM X 6CM DELTAXSFT10 (DLX100206, L16259) FAILED TO DETACH AFTER DEPLOYING THE COIL INTO THE ANEURYSM. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DETACHMENT CONTROL BOX (DCB) AND THE SAME CONTROL CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. IT WAS REPORTED THAT THE SAME COIL WAS FINALLY IMPLANTED IN THE PATIENT, HOWEVER, IT WAS ALSO NOTED THAT THE ACTUAL COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT AND IS AVAILABLE FOR RETURN, (THIS WILL BE FURTHER INVESTIGATED). THE COIL DID NOT BECOME STRETCHED OR DAMAGED WHEN REMOVED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. IT WAS NOT NECESSARY TO REMOVE THE CONCOMITANT DEVICES WITH THE COMPLAINT DEVICE. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THE TARGET SITE WAS NOT TORTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744732 ↗
• MalfunctionFeb 3, 2021Device Difficult to Setup or Prepare; Material Rupture; Device Difficult to Setup or Prepare; Material Rupture

  AS REPORTED BY THE FIELD, DURING THE RE-SHEATHING OF A 2MM X 6CM DELTAXSFT10 COIL (DLX100206, L16193), THE INTRODUCER FAILED TO BE RE-ZIPPED. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273868 ↗
• MalfunctionMay 8, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE INTRODUCER ON THE 2MM X 6CM DELTAXSFT 10 COIL (DLX100206 / L15203) COULD NOT BE RE-ZIPPED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN KINKED CONDITION. BASED ON THE PRODUCT ANALYSIS 05/05/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10041011 ↗
• MalfunctionFeb 20, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE PHYSICIAN DID NOT LIKE THE SHAPE OF A 2MM X 6CM DELTAXSFT10 COIL (DLX100206, L15798) AND DECIDED TO PULL IT OUT. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THE 2MM X 6CM DELTAXSFT10 COIL WAS THE THIRD COIL BEING USED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732221 ↗
• MalfunctionOct 14, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE DEPLOYED 2MM X 6CM DELTAXSFT 10 COIL (DLX100206 / L15279) AND DECIDED TO REMOVE THE COIL FROM THE TARGET SITE. DURING THE RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN REPLACED THE COIL WITH ANOTHER DELTAXSFT 10 COIL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 9189104 ↗
• MalfunctionAug 15, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION FOR A PERIPHERAL ARTERIAL MALFORMATION AT THE SUPRADUODENAL ARTERY, A 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) COULD NOT BE INSERTED AND BECAME ¿STUCK¿ IN THE SHEATH¿S HUB. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) AND THE SAME ISSUE OCCURRED. THEREFORE, THIS DEVICE WAS REPLACED WITH A DIFFERENT SIZE COIL (2MM X 4MM DELTAXSFT). THREE MORE COILS WERE IMPLANTED WITH NO ISSUES AT THE TARGET LESION 3MM X 4MM DELTAXSF, 4MM X 8MM FRAME-C AND 3MM X 12MM DELTAFILL18. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. INITIALLY TWO COILS (1.5MM X 2MM AND 2MM X 4MM DELTAXSFT) WERE IMPLANTED IN THE TARGET LESION. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. NO KINK OR BEND WERE CONFIRMED PRIOR TO USE OF THE DEVICES. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE, THE EMBOLIC COIL (DLX100206, S13463) WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897358 ↗
• MalfunctionAug 15, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION FOR A PERIPHERAL ARTERIAL MALFORMATION AT THE SUPRADUODENAL ARTERY, A 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) COULD NOT BE INSERTED AND BECAME ¿STUCK¿ IN THE SHEATH¿S HUB. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) AND THE SAME ISSUE OCCURRED. THEREFORE, THIS DEVICE WAS REPLACED WITH A DIFFERENT SIZE COIL (2MM X 4MM DELTAXSFT). THREE MORE COILS WERE IMPLANTED WITH NO ISSUES AT THE TARGET LESION 3MM X 4MM DELTAXSF, 4MM X 8MM FRAME-C AND 3MM X 12MM DELTAFILL18. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. INITIALLY TWO COILS (1.5MM X 2MM AND 2MM X 4MM DELTAXSFT) WERE IMPLANTED IN THE TARGET LESION. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. NO KINK OR BEND WERE CONFIRMED PRIOR TO USE OF THE DEVICES. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE, THE EMBOLIC COIL (DLX100206, S13463) WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897346 ↗
• MalfunctionMay 1, 2019Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 2 MM X 6 CM DELTAXSFT 10 COIL (DLX100206 / L11206) DID NOT ADVANCE THROUGH THE SL-10®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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569828 ↗
• MalfunctionDec 21, 2018Migration; Migration

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, FOLLOWING DEPLOYMENT OF THE NEXT TO LAST THERMO-MECHANICAL COIL, 2.5MM X 6CM DELTAXSFT10 (DLX100256/L11405), THE EMBOLIC COIL TAIL PROTRUDED FROM THE ANEURYSM INTO THE PARENT VESSEL. FOLLOWING DEPLOYMENT OF THE LAST THERMO-MECHANICAL COIL, 2MM X 6CM DELTAXSFT10 (DLX100206/L10697), A SECOND COIL LOOP PROTRUDED FROM THE ANEURYSM INTO THE PARENT VESSEL. THE PHYSICIAN MENTIONED THAT THERE WERE ISSUES RELATED TO COIL SHAPE WHICH HE BELIEVES RESULTED IN COIL PROTRUSION. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THESE EVENTS. PRELIMINARY REVIEW OF THE IMAGING PROVIDED CONFIRMED COIL PROTRUSION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THESE EVENTS. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8192535 ↗
• MalfunctionDec 21, 2018Migration; Migration

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THERE WERE ISSUES RELATED TO COIL SHAPE IN WHICH THE PHYSICIAN STATED RESULTED IN LOOPS OF THE 2MM X 6CM DELTAXSFT10 (DLX100206/L10600) THERMO-MECHANICAL COIL PROTRUDING FROM THE ANEURYSM INTO THE PARENT VESSEL AFTER DETACHMENT. THE PHYSICIAN BELIEVES THAT THIS WAS THE LAST COIL PLACED IN THE ANEURYSM. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. PRELIMINARY REVIEW OF THE IMAGING PROVIDED CONFIRMED COIL PROTRUSION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8192533 ↗
• MalfunctionDec 13, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED CEREBRAL ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE FIRST 2MM X 6CM DELTAXSFT 10 COIL (DLX100206 / S13960) WAS REMOVED FROM ITS PACKAGING AND THE PHYSICIAN ATTEMPTED TO INSERT IT INTO THE STRYKER SL-10® MICROCATHETER, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER. THE COIL WAS REPLACED WITH A SECOND 2MM X 6CM DELTAXSFT 10 COIL (DLX100206) FROM THE SAME LOT (S13960). THE SAME ISSUE OCCURRED WITH THIS SECOND COIL WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE COIL INTO THE STRYKER SL-10® MICROCATHETER. THE COIL WAS REPLACED, AND THE PROCEDURE CONTINUED TO COMPLETION 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 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 2MM X 6CM DELTAXSFT 10 COIL WAS REPORTED AS AVAILABLE TO BE RETURNED F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162195 ↗
• MalfunctionDec 13, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED CEREBRAL ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE 2MM X 6CM DELTAXSFT 10 COIL (DLX100206 / S13960) WAS REMOVED FROM ITS PACKAGING AND THE PHYSICIAN ATTEMPTED TO INSERT IT INTO THE STRYKER SL-10® MICROCATHETER, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER. THE COIL WAS REPLACED WITH A SECOND 2MM X 6CM DELTAXSFT 10 COIL FROM THE SAME LOT AND THE SAME ISSUE OCCURRED. THIS SECOND COIL WAS REPLACED, AND THE PROCEDURE CONTINUED TO COMPLETION 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 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 2MM X 6CM DELTAXSFT 10 COIL WAS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162192 ↗
• MalfunctionOct 28, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE DELTAXSFT 10 2MM X 6CM COIL (DLX100206 / L10673) DID NOT PASS THROUGH THE MICROCATHETER. LIMITED INFORMATION IS AVAILABLE RELATED TO THE DETAILS OF THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8011490 ↗
• MalfunctionOct 26, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE DELTAXSFT 10 2MM X 6CM COIL (DLX100206 / L10673) DID NOT PASS THROUGH THE MICROCATHETER. LIMITED INFORMATION IS AVAILABLE RELATED TO THE DETAILS OF THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010725 ↗
• MalfunctionOct 26, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT (SG) COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT ILIAC ARTERY, THE DELTAXSFT 10 2MM X 6CM COIL (DLX100206 / S13718) WAS INSERTED INTO THE MICROCATHETER, THERE WAS RESISTANCE IN THE SHEATH INTRODUCER. THE MICROCATHETER WAS FLUSHED AND THE DELTA XSFT 10 COIL WAS RE-INSERTED, THE COIL WAS EXPOSED FROM THE SLIT OF THE SHEATH. IT WAS CONFIRMED THAT THE PHYSICIAN DID NOT APPLY EXCESSIVE FORCE DURING THE UNSHEATHING AND RESHEATHING OF THE DEVICE. 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 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 DELTA XSFT 10 COIL WAS RETURNED FOR EVALUATION AND IT WAS NOTED THAT THE COIL WAS SIGNIFICANTLY KINKED AND SLIGHTLY STRETCHED IN THE PROXIMAL AREA OUTSIDE OF THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010523 ↗
• MalfunctionOct 18, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A CAROTID-CAVERNOUS FISTULA (CCF) AT THE SUPERIOR OPHTHALMIC VEIN (SOV) AND CAVERNOUS SINUS (CS), THE SHEATH INTRODUCER OF THE 2MM X 6CM DELTAXSFT10 (DLX100206/S13813) THERMO-MECHANICAL COIL WAS INSERTED INTO THE CONCOMITANT Y-CONNECTOR AND THEY WERE FLUSHED; HOWEVER, WHILE THE COIL WAS BEING ADVANCED INTO THE EXCELSIOR XT-17 (STRYKER) MICROCATHETER, THE COIL BECAME STUCK AND WOULD NOT EXIT THE INTRODUCER. THE COIL WAS REPLACED WITH A COIL FROM THE SAME LOT, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURE WAS NOT DELAYED DUE TO THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND AFTER THE EVENT. A SUPER SHEATH (BOSTON SCIENTIFIC) SHEATH INTRODUCER, 0.014¿ 200CM CHIKAI BLACK (ASAHI INTECC) GUIDEWIRE, 6F SHUTTLE SHEATH (COOK) GUIDING CATHETER, AND AN ENPOWER DCB2 DETACHMEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7982516 ↗
• MalfunctionOct 18, 2018Material Separation; Material Deformation; Material Separation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A CAROTID-CAVERNOUS FISTULA (CCF) AT THE SUPERIOR OPHTHALMIC VEIN (SOV) AND CAVERNOUS SINUS (CS), THE SHEATH INTRODUCER OF THE 2MM X 6CM DELTAXSFT10 (DLX100206/S13813) THERMO-MECHANICAL COIL WAS INSERTED INTO THE CONCOMITANT Y-CONNECTOR AND THEY WERE FLUSHED; HOWEVER, WHILE THE COIL WAS BEING ADVANCED INTO THE EXCELSIOR XT-17 (STRYKER) MICROCATHETER, THE COIL BECAME STUCK AND WOULD NOT EXIT THE INTRODUCER. THE COIL WAS REPLACED WITH A COIL FROM THE SAME LOT, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURE WAS NOT DELAYED DUE TO THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND AFTER THE EVENT. A SUPER SHEATH (BOSTON SCIENTIFIC) SHEATH INTRODUCER, 0.014¿ 200CM CHIKAI BLACK (ASAHI INTECC) GUIDEWIRE, 6F SHUTTLE SHEATH (COOK) GUIDING CATHETER, AND AN ENPOWER DCB2 DETACHMEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7982508 ↗
• MalfunctionOct 8, 2018Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE VERTEBRAL ARTERY (VA) CEREBRAL ARTERY. THE RIGHT FEMORAL ARTERY (FA) WAS PUNCTURED AND THE 6 FR GUIDING CATHETER (SLIMGUIDE, MEDIKIT) WAS INSERTED TOWARD THE RIGHT VERTEBRAL ARTERY (VA). AFTER THE ENTERPRISE WAS PLACED, TWO MICROCATHETERS (JAILING, HEADWAY 17, TERUMO AND TRANS CELL) WERE USED, FOURTEEN (14) COILS (CERENOVUS AND COMPETITIVE COILS) WERE PLACED. THE DELTAXSFT 10 2MM X 6CM (DLX100206 / S12386) WAS INSERTED INTO THE LESION FOR LEAD. THE PHYSICIAN ATTEMPTED TO PRESS THE DETACHMENT BUTTON ON THE DETACHMENT CONTROL BOX, BUT THE COIL DID NOT DETACH. THE COIL WAS REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM AND IT WAS REPLACED WITH ANOTHER DELTAXSOFT 10 COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THE SAME DETACHMENT CONTROL BOX WAS USED TO DETACH THE COIL. IT WAS CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, AND THE LOW BATTERY LIGHT WAS NOT SEEN DURING THE PROCEDURE. 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 ACC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943678 ↗
• MalfunctionSep 6, 2018Stretched; Material Deformation; Stretched; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A GASTROINTESTINAL HEMORRHAGE (TWO BRANCHES), THE 2MM X 6CM DELTAXSFT10 (DLX100206/S13030) THERMO-MECHANICAL COIL WAS SELECTED FOR USE AS THE LAST COIL BUT THE COIL BECAME STUCK IN THE PROWLER SELECT LPES (UNK CATALOG & LOT) MICROCATHETER. THE PHYSICIAN FELT THAT THE ANEURYSM WAS SUCCESSFULLY TREATED WITHOUT NEED FOR ADDITIONAL COILING. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. IN THE ONE OF THE TWO LESIONS, TWO COILS (DELTAFILL10 & MICRUSFRAMEC) WERE PLACED IN THE LESION WITHOUT INCIDENT. IN THIS LESION, A MICRUSFRAMEC COIL WAS UTILIZED AS THE FIRST COIL. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. AN ENPOWER DCB2 DETACHMENT CONTROL BOX AND ENPOWER CONTROL CABLE WERE ALSO USED FOR THE CASE. THE SALES REPRESENTATIVE ADVISED THE USER TO FLUSH THE MICROCATHETER BEFORE USE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7851623 ↗