DELTAFILL DLF182460Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886704077183), received between Jan 4, 2018 and Jan 30, 2026 — classified as 13 malfunctions.

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

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Entrapment of Device; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF A GASTRIC VEIN WITH BALLOON OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) USING A 4 FR ANGIOGRAPHIC CATHETER AND AN EXCELSIOR® 1018® MICROCATHETER (STRYKER), DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS), THE FIRST TWO COILS USED WERE TARGET¿ XXL 24MM COILS (STRYKER) AND FRAMING WERE PERFORMED AFTER WHICH THE PHYSICIAN ATTEMPTED TO PLACE THE 24MM X 60CM DELTAFILL 18 (DLF182460 / 2862563S). IT WAS REPORTED THAT ¿BECAUSE IT WOULD NOT BE WOUND PROPERLY, [THE PHYSICIAN] ATTEMPTED TO REMOVE THE 24MM X 60CM DELTAFILL 18 COIL, BUT IT UNRAVELED.¿ THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT¿S BODY, AND A RE-APPROACH WAS MADE AND A NEW DELTAFILL COIL OF DIFFERENT SPECIFICATIONS WAS DEPLOYED. AFTERWARDS, COILS FROM A DIFFERENT MANUFACTURER WERE USED AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 23-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE COIL WAS NOT DETACHED WHEN IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225127 ↗
• MalfunctionNov 12, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY TO TREAT AN ABDOMINAL AORTIC ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). AFTER THE ANGIOGRAPHY CATHETER AND COILING SUPPORT CATHETER (MEDICOS HIRATA) APPROACHED THE INTERNAL ILIAC ARTERY, A MICRUSFRAME COIL WAS PLACED AS THE FIRST COIL AND A 20MM X 60CM DELTAFILL 18 (DLF182060) WAS PLACED INSIDE. THE 24MM X 60CM DELTAFILL 18 (DLF182460 / 1712508S) WAS THE THIRD COIL USED. AN ATTEMPT WAS MADE TO DEPLOY THE COIL, BUT ¿IT COULD NOT BE ENERGIZED AND COULD NOT BE DETACHED.¿ IT WAS THEN REPORTED THAT ANOTHER COIL HAD BEEN SUCCESSFULLY DETACHED, THE PHYSICIAN DETERMINED THAT IT WAS THE THIRD COIL THAT HAD THE PROBLEM AND REMOVED IT FROM THE PATIENT¿S BODY. THE 24MM X 60CM DELTAFILL 18 (DLF182460) WAS REPLACED WITH ANOTHER COIL OF THE SAME SPECIFICATION, AND IT WAS IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 06-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS STILL ATTACHED TO THE DELIVERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534263 ↗
• MalfunctionAug 16, 2021Device Difficult to Setup or Prepare; Difficult to Advance; Device Difficult to Setup or Prepare; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), A 24MM X 60CM DELTAFILL18 COIL (DLF182460, 30399404) WAS USED. THERE WAS AN INTENSIVE RESISTANCE FELT SHORTLY AFTER IT ADVANCED THROUGH THE PROWLER SELECT PLUS MICROCATHETER (MC). IT WAS NOT ABLE TO BE RE-SHEATHED. IT WAS REPLACED WITH ANOTHER SAME SIZED COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND BROKEN AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325485 ↗
• MalfunctionFeb 11, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT COIL EMBOLIZATION PROCEDURE WITH THE TARGET AT THE INTERNAL ILIAC ARTERY, AFTER THE FIRST 24MM X 60CM DELTAFILL 18 COIL (DLF182460 / 30422240) WAS THE USED AND THERE WAS RESISTANCE FELT AND THE PHYSICIAN COULD NOT ADVANCE THE COIL. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL; HOWEVER, IT HAD BECOME UNRAVELED AND THE PHYSICIAN REMOVED IT WITH THE CONCOMITANT BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC). THIS SECOND 24MM X 60CM DELTAFILL 18 COIL (DLF182460 / 30422240) WAS CHOSEN FOR USE BUT THE SAME ISSUE OCCURRED, AND THIS COIL WAS ALSO REMOVED WITH THE CONCOMITANT MICROCATHETER. IT IS NOT CLEAR IF THIS COIL ALSO BECAME UNRAVELED. THE PHYSICIAN OPTED TO USE ANOTHER COIL OF A DIFFERENT SIZE (14MM) AND IT WAS PLACED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED WITH FIVE IMPLANTED COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT CONTINUOUS FLUSH HAD NOT BEEN MAINTAINED THROUGH THE CONCOMITANT BREAKTHROUGH¿ MICROCATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318237 ↗
• MalfunctionFeb 11, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT COIL EMBOLIZATION PROCEDURE WITH THE TARGET AT THE INTERNAL ILIAC ARTERY, THE 24MM X 60CM DELTAFILL 18 COIL (DLF182460 / 30422240) WAS THE USED AS THE FIRST COIL, BUT THERE WAS RESISTANCE FELT AND THE PHYSICIAN COULD NOT ADVANCE THE COIL. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL; HOWEVER, IT HAD BECOME UNRAVELED. AS A RESULT, IT WAS REMOVED WITH THE CONCOMITANT BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC). ANOTHER 24MM X 60CM DELTAFILL 18 COIL (DLF182460 / 30422240) WAS USED, BUT THE SAME ISSUE OCCURRED, AND THIS COIL WAS ALSO REMOVED WITH THE CONCOMITANT MICROCATHETER. THE PHYSICIAN OPTED TO USE ANOTHER COIL OF A DIFFERENT SIZE (14MM) AND IT WAS PLACED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED WITH FIVE IMPLANTED COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT CONTINUOUS FLUSH HAD NOT BEEN MAINTAINED THROUGH THE CONCOMITANT BREAKTHROUGH¿ MICROCATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318216 ↗
• MalfunctionFeb 11, 2021Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR RECURRENCE OF THE RENAL ARTERY ANEURYSM, A 24MM X 60CM DELTAFILL18 COIL (DLF182460, L16406) WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL EMBOLIZATION STARTED AFTER A CARNELIAN MARVEL 2.0 MICROCATHETER (MC) WAS DELIVERED TO THE SITE OF RECURRENCE. THE DELTAFILL18 COIL (LOT L16406) WAS USED AS THE FIRST COIL BUT THERE WAS A RESISTANCE FROM A PART OF THE MICROCATHETER. THE PHYSICIAN JUDGED THAT FURTHER PUSHING MUST BE DANGEROUS. WHEN IT WAS RETRIEVED, THE SHEATH PART WAS BROKEN. AFTER THAT, A 18MM X 55CM DELTAFILL18 COIL (DLF181855) WAS IMPLANTED WITHOUT ANY PROBLEMS. THEN A 24MM X 60CM COIL (DLF182460, L17040) WAS INSERTED BUT IT GOT UNLABELED ON THE WAY. THEREFORE, THE COIL AND THE DELIVERY WIRE WERE DETACHED, AND THIS COMPLAINT COIL WAS PUSHED BY A COIL PUSHER TO BE OUT OF THE MICROCATHETER AND THE COIL WAS PLACED. THE SITE WHERE THE COIL WAS IMPLANTED WAS THE SITE WHERE COIL EMBOLIZATION WAS PERFORMED AT THE BEGINNING, AND THEREFORE THE PLACEMENT WAS CONFIRMED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. NO EXCESSIVE FORCE WAS APPLIED TO EITHER OF THE COILS. THERE WAS NO BLOOD FLOW RESTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313544 ↗
• MalfunctionAug 22, 2019Separation Failure; Separation Failure

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF A DISSECTING ANEURYSM, 24MM X 60CM DELTAFILL18 COIL, WAS INSERTED INTO THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL AND PRESSED THE DETACHMENT BUTTON AFTER A AB ENPOWER CONTROL CABLE (ECB00018200, L13631) WAS CONNECTED. THE COIL COULD NOT BE DETACHED EVEN THOUGH THE SOUND WAS HEARD. THE PHYSICIAN ATTEMPTED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH A COMPETITIVE PRODUCT AND THE PROCEDURE WAS CONTINUED. SINCE THE COIL WAS REPLACED BEFORE THE PHYSICIAN IDENTIFY THE CAUSE OF THE ISSUE, IT IS UNKNOWN WHETHER THE ISSUE WAS WITH THE COIL OR THE CABLE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920960 ↗
• MalfunctionApr 25, 2019Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL INTRODUCER SHEATH OF THE 24 MM X 60 CM DELTAFILL 18 COIL (DLF182460 / S14759) WAS PRESSED AGAINST THE CONCOMITANT MICROCATHETER HUB AND THE DELIVERY WIRE ADVANCED INTO THE MICROCATHETER. RESISTANCE WAS ENCOUNTERED AS THE DEVICE ADVANCES AND AS A RESULT, THE DELIVERY WIRE WAS WITHDRAWN AND REMOVED FROM THE PATIENT¿S BODY. IT WAS CONFIRMED THAT THE COIL HAD BECOME PREMATURELY DETACHED. IT WAS REPORTED THAT THE COIL WAS NOT CONNECTED TO THE CONTROL CABLE. THE COIL WAS REPLACED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8553021 ↗
• MalfunctionOct 24, 2018Material Too Soft/Flexible; Material Too Soft/Flexible

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE SPLENIC ARTERY, THE DELTAFILL 18 24MM X 60CM COIL (DLF182460 / S10238) WAS USED BUT THE DELTAFILL 18 COIL DID NOT MAKE THE ADEQUATE SHAPE AS THE PHYSICIAN HAD EXPECTED IT. WHEN THE PHYSICIAN ATTEMPTED TO RESHEATH IT, THE SHEATH INTRODUCER BECAME DAMAGED. THE DELTAFILL 18 COIL WAS REPLACED WITH ANOTHER DELTAFILL 18 OF THE SAME SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. IT WAS CONFIRMED THAT THERE WAS NO DIFFICULTY WITH POSITIONING THE DELTAFILL 18 COIL AT THE TARGET SITE, NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER, THERE WAS NO DAMAGE TO THE DEVICE INNER PACKAGING OR TO THE ACTUAL COIL PRIOR TO USE, THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY ISSUE, AND THE PHYSICIAN DID NOT APPLY EXCESSIVE FORCE DURING THE UNSHEATHING AND RESHEATHING OF THE DEVICE. 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. T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000773 ↗
• MalfunctionFeb 20, 2018Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM (23MMX16MM/NECK WAS18MM) AT THE INTERNAL CAROTID (IC) TIP, THE DELTAFILL 18 (DLF182460, (B)(4)) WAS INSERTED AND WAS ATTEMPTED TO DETACH AS THE 2ND COIL BUT IT COULD NOT BE DETACHED ALTHOUGH PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED WITH THE CONTROL BOX AND THE ENPOWER CONNECTING CABLE (ECB000182, (B)(4)) WITHOUT ANY PROBLEMS. AFTER THAT, THE PHYSICIAN TRIED TO DETACH THE COIL TWICE AND THE CABLE WAS CHANGED BUT THE ISSUE CONTINUED. THE COIL WAS ATTEMPTED TO BE REMOVED, THEN THE PHYSICIAN NOTICED THAT THE COIL JUST GOT STUCK WHEN THE COIL WAS IN AND OUT REPEATEDLY. THEREFORE, THE WIRE WAS PUT IN AND OUT BY THE CATHETER TIP, THEN THE SAME COIL WAS DETACHED SUCCESSFULLY AND IT WAS PLACED IN THE LESION. AFTER THAT, ANOTHER DELATFILL18 WAS USED, 7 NON-CERENOVUS COILS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY AND A 6F SHEATH AND A GUIDING CATHETER (6FR FYBUKI, ASAHI INTECC) WERE DELIVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281731 ↗
• MalfunctionJan 8, 2018Stretched; Physical Resistance; Device Operational Issue; Stretched; Physical Resistance; Device Operational Issue

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE AORTIC ARCH OF THE SUBCLAVIAN ARTERY FOR A TYPE 2 ENDOLEAK AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) ONE DELTAFILL COIL (DLF181040/S13153) COULD NOT BE RESHEATHED AND ANOTHER DELTAFILL COIL (DLF182460/ S13373) EXPERIENCED RESISTANCE THROUGH THE MICROCATHETER. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND NOT CALCIFIED. A SHEATH INTRODUCER (6F), A GUIDEWIRE (RADIFOCUS GT GW, TERUMO), GUIDING CATHETER (6F MAC 1, STRYKER), MICRO CATHETER (PROGREAT, TERUMO) AND A BALLOON CATHETER (SELECON MP, TERUMO CLINICAL SUPPLY) WERE ALSO USED FOR THIS PROCEDURE. AN APPROACH WAS TAKEN FROM THE RIGHT FEMORAL ARTERY WITH THE SHEATH INTRODUCER. THE GUIDING CATHETER, TWO CATHETERS (4.2FR GOODTECH CATHERER, GOODMAN) AND (RUBICON, BOSTON SCIENTIFIC) ADVANCED BETWEEN SG AND THE VASCULAR WALL. COIL EMBOLIZATION WAS INITIATED WITH USING THE MICRO CATHETER. THE FIRST MICRO COIL WAS A DELTAFILL (10MM*40CM). THE SIXTH MICRO COIL WAS THE DELTAFILL18 (DLF181040/S13153) AND IT WAS UNDER-SIZED FOR THE ANEURYSM AT THAT POINT, SO THE PHYSICIAN TRIED TO RE-SHEATH THE COIL BUT IT COULD NOT BE ZIPPED PROPERLY AND THE COIL WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7172008 ↗
• MalfunctionJan 4, 2018Positioning Failure; Positioning Failure

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT IIA, A DELTAFILL COIL (DLF182460, S13441) WAS UNRAVELED IN THE MICRO CATHETER AND COULD NOT BE USED AT ALL . WHEN THE COIL WAS REMOVED, IT WAS TEARED. THE TEARED COIL WAS REMOVED TO THE OUT OF THE BODY. THE COIL WAS REPLACED WITH ANOTHER DELTAFILL COIL (SAME CATALOG/LOT NUMBER) COULD NOT BE DETACHED ALTHOUGH IT WAS ENERGIZED TWICE. THE POWER LAMP DID NOT TURN ON WHEN TRYING THE THIRD DETACHMENT. THE ENPOWER CONTROL CABLE (ECB00018200, S13745) WAS REPLACED BUT THE POWER LUMP DID NOT TURN ON. THE COIL WAS REPLACED WITH ANOTHER DELTAFILL COIL (SAME CATALOG/LOT NUMBER). THE COIL WAS INSERTED INTO THE MICRO CATHETER BUT THERE WAS RESISTANCE FELT IN THE CATHETER AND COULD NOT BE USED AT ALL. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURY / OR COMPLICATIONS REPORTED. THE PRODUCTS WILL BE RETURNED FOR INVESTIGATION. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. INITIALLY, AN APPROACH WAS TAKEN FOR THE FEMORAL ARTERY WITH A TERUMO SHEATH INTRODUCER. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163476 ↗
• MalfunctionJan 4, 2018Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT IIA, A DELTAFILL COIL (DLF182460,S13441) WAS UNRAVELED IN THE MICRO CATHETER AND COULD NOT BE USED AT ALL . WHEN THE COIL WAS REMOVED, IT WAS TEARED. THE TEARED COIL WAS REMOVED TO THE OUT OF THE BODY. THE COIL WAS REPLACED WITH ANOTHER DELTAFILL COIL (SAME CATALOG/LOT NUMBER) COULD NOT BE DETACHED ALTHOUGH IT WAS ENERGIZED TWICE. THE POWER LAMP DID NOT TURN ON WHEN TRYING THE THIRD DETACHMENT. THE ENPOWER CONTROL CABLE (ECB00018200, S13745) WAS REPLACED BUT THE POWER LUMP DID NOT TURN ON. THE COIL WAS REPLACED WITH ANOTHER DELTAFILL COIL (SAME CATALOG/LOT NUMBER). THE COIL WAS INSERTED INTO THE MICRO CATHETER BUT THERE WAS RESISTANCE FELT IN THE CATHETER AND COULD NOT BE USED AT ALL. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURY / OR COMPLICATIONS REPORTED. THE PRODUCTS WILL BE RETURNED FOR INVESTIGATION. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. INITIALLY, AN APPROACH WAS TAKEN FOR THE FEMORAL ARTERY WITH A TERUMO SHEATH INTRODUCER. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163466 ↗