Concerto Detachable Coil System PV-20-50-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00847536045064), received between Mar 7, 2023 and Sep 29, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation; Physical Resistance/Sticking

  Medtronic received information regarding two Concerto coils that had resistance during delivery and were damaged. The patient was undergoing an internal iliac artery embolization procedure. Patient's blood flow was normal and vessel tortuosity was severe. It was reported that the Concerto coils and all accessory devices were prepared as indicated in the instructions for use (IFU) with no friction or other issue noted. Continuous catheter flush was not administered during the procedure. During delivery, the coils experienced resistance during attempted delivery. Both coils became damaged, taking a "spring-like" shape due to the excessive force required to push them. Damage to the middle segment of the pushwire was noted. It was additionally noted that the physician did not reposition the coil at any time during the procedure. It was additionally noted that there was no friction or other difficulty during device testing or delivery despite report that excessive force was required to push them. There was no harm or injury to the patient associated with this event. Additional information was received clarifying that, excessive force was required while pushing the coils. It is unknown w

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927449 ↗
• MalfunctionApr 20, 2026Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS NOT USED ON PATIENT. THERE WAS ACCESSORY DEVICE INCOMPATIBILITY. A 0.18" MICROCATHETER WAS USED BECAUSE A REBAR 18 CATHETER WAS NOT AVAILABLE DUE TO A BACK ORDER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE ISSUE WAS RESOLVED ON (B)(6) 2026. THE PATIENT WAS SUPPOSED TO UNDERGO THORACOABDOMINAL ANEURYSM EMBOLIZATION SURGERY OF THE POLAR LEFT RENAL ARTERY. IT HAD A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. ANCILLARY DEVICES INCLUDE A VERTEBRAL CATHETER 5FR DIAGNOSTIC CATHETER AND A MOMA 150 BOSTON SCIENTIFIC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929583 ↗
• MalfunctionMar 10, 2026Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT MANUAL DETACHMENT HAD BEEN ATTEMPTED PRIOR TO THE PREMATURE DETACHMENT. THERE WAS NO DAMAGE OBSERVED TO THE CONCERTO PUSHWIRE. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION; IT WAS REMOVED FROM THE PATIENT WITH NO ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559503 ↗
• MalfunctionMar 2, 2026Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PUSHWIRE DISTAL SEGMENT WAS BROKEN. THE PATIENT WAS UNDERGOING INTERNAL ILIAC ARTERY (IIA) EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PUSHWIRE WAS FOUND SEPARATED WHILE REINSERTING TO THE MICROCATHETER. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481348 ↗
• MalfunctionDec 2, 2025Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Packaging Problem; Physical Resistance/Sticking; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Packaging Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING AN ATTEMPT TO REMOVE A CONCERTO HELIX COIL FROM THE PACKAGING HOOP, THE PLASTIC TUBE COVERING THE COIL REMAINED IN THE HOOP RESULTING IN FULL DEPLOYMENT OF THE COIL. THE COIL WAS REPLACED WITH A NEW COIL OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED A REBAR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694026 ↗
• MalfunctionDec 1, 2025Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE COIL RESISTANCE AND DAMAGE COULD NOT BE DETERMINED. THE COIL EXPERIENCED SEPARATION, BUT WAS NOT SEPARATED INTO TWO OR MORE PIECES. THE EVENT WAS CLASSIFIED AS SEPARATION RATHER THAN BREAKAGE OR PREMATURE DETACHMENT. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AS IT WAS NOT MOVING FORWARD FROM SOMEWHERE IN THE MIDDLE OF THE MICROCATHETER. NO SPECIFIC ISSUES WERE IDENTIFIED THAT RESULTED IN THE OBSERVED DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681821 ↗
• MalfunctionDec 1, 2025Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS ENCOUNTERED RESISTANCE IN THE PROGREAT MICROCATHETER AND WERE DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE PULMONARY ARTERY WITH A MAX DIAMETER OF 13 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PHYSICIAN INITIATED THE CONCERTO 20X50 DEPLOYMENT THROUGH THE MICROCATHETER WITH CONTINUOUS FLUSHING, BUT THE CONCERTO COIL WAS NOT MOVING FORWARD THROUGH THE MICROCATHETER, THE DOCTOR PULLED THE COIL BACK AND INITIATED CONCERTO COIL 18X40 DEPLOYMENT WHICH WAS DONE SUCCESSFULLY. THE PHYSICIAN TOOK THE FIRST ATTEMPTED CONCERTO 20X50 DEPLOYMENT WHICH GOT STUCK AGAIN IN MICROCATHETER AND THE COIL WAS DAMAGED. THEN THE PHYSICIAN TOOK ANOTHER CONCERTO 20X50 COIL FOR DEPLOYMENT WHICH WAS AGAIN STUCK IN SAME MICROCATHETER, THUS, WITHDRAWAL OF COIL AGAIN. CASE WAS COMPLETED WITH OTHER MANUFACTURERS COILS. IT WAS REPORTED THE COILS WERE STUCK IN THE MIDDLE OF THE MICROCATHETER. THE CATHETER WAS NOT DAMAGED. THE COILS WERE DAMAGED. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681812 ↗
• MalfunctionNov 7, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT CONCERTO HELIX COIL DID NOT DETACH. A TOTAL OF 9 COILS TOTAL WERE USED, WITH THIS ONE BEING THE ONLY ISSUE. THE COIL WAS REPLACED WITH A NEW CONCERTO HELIX COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT INTERNAL ILIAC ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THAT THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE AND THERE WERE NO ISSUES WITH THE INSTANT DETACHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503678 ↗
• InjuryOct 31, 2025Stretched; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS AN EMBOLIZATION PROCEDURE FOR PELVIC VARICES IN A PATIENT WITH SYMPTOMATIC PELVIC CONGESTION SYNDROME. THE INITIAL PHLEBOGRAPHY AFTER SELECTIVE CATHETERIZATION OF THE LEFT GONADAL VEIN REVEALED OVARIAN AND PERI-UTERINE VARICES, WITH A SIGNIFICANT EARLY PELVIC LEAK POINT (EARLY OPACIFICATION OF THE LEFT INTERNAL ILIAC VEIN). EMBOLIZATION OF THE LEFT GONADAL VEIN WAS PERFORMED USING DETACHABLE COILS, CONTROLLED WITH CONCERTO HELIX. TWO 18 MM COILS WERE SUCCESSFULLY DEPLOYED WITHOUT INCIDENT. DURING THE PLACEMENT OF A CONCERTO COIL (20 MM DIAMETER X 50 MM, HELIX REF PV-20-50-HELIX, LOT D008415), IT WAS NOT POSSIBLE TO DETACH THE COIL, WHICH RESULTED IN UNRAVELING OF THE PROXIMAL PART OF THE COIL, WHICH BECAME IMPACTED IN THE CATHETER. IT WAS IMPOSSIBLE TO PROPERLY RELEASE OR RETRIEVE THE DEVICE. THE PROXIMAL END OF THE UNRAVELED COIL WAS PRESENT IN THE SUPERIOR VENA CAVA AT THE END OF THE PROCEDURE. CURRENT PATIENT STATUS WAS NOT REPORTED. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT INCLUDED REMOVAL OF THE DEVICE. VASCULAR SURGEON WAS CONSULTED FOR AN OPINION. THEN, CONTACT WAS MADE WITH THE HOSPITAL WHERE THE PATIENT WOUL

  Patient problems: Foreign Body In Patient

  MAUDE report 23442410 ↗
• MalfunctionAug 11, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT CONCERTO COIL WAS USED DURING A HYPOGASTRIC EMBOLIZATION PROCEDURE "DID NOT STAND OUT EITHER WITH THE HIGHLIGHTER OR BY HAND". THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE DEVICE AND ACCESSORY DEVICES, INCLUDING A SPRING DETACHER, WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776646 ↗
• MalfunctionJul 23, 2025Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. FOR COILS PV-20-50-HELIX, LOT D036397, THE INTRODUCER SHEATH WAS HELD HORIZONTALLY DURING HYDRATION WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE. FOR COIL PV-18-40-HELIX, LOT D012376, IT WAS REPORTED THAT PRIOR TO THE NON-DETACHMENT EVENT, NO ISSUES WERE ENCOUNTERED, AND THE DETACHER DID NOT SHOW ANY VISUAL PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577731 ↗
• MalfunctionJun 24, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COILS (LOT 229646653 AND 229927355) COULD NOT BE DETACHED BY DETACHER, AND PHYSICIAN REFUSED TO USE BACK UP DEPLOYMENT. THERE WAS NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. COIL (LOT 228640128) COULD NOT BE DETACHED BY DETACHER, AND PHYSICIAN BROKE THE HYPOTUBE, THE COIL DID NOT SEPARATE INSTANTLY, WHILE RETRIEVING THE COIL FROM PATIENT, THE COIL SUDDENLY DEPOLYED, AND GOT STUCK IN MICROCATHETER (LOT B615929). THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES  AND 1 TIME USING THE MANUAL METHOD. TWO INSTANT DETACHERS WERE USED. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER TWICE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. COIL (LOT B643

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322796 ↗
• MalfunctionApr 18, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING THE CONCERTO COIL DID NOT DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866272 ↗
• MalfunctionMar 19, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL HAD DETACHMENT ISSUES. IT WAS REPORTED THAT THE COIL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES AND DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE WAS TRIED 2 TIMES. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE NOT PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AS THERE WAS NO CONTINUOUS FLUSH. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644592 ↗
• MalfunctionFeb 3, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE COIL COULD NOT BE DELIVERED BUT WAS STUCK IN THE MICROCATHETER. THE CATHETER RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE ISSUE WAS ONLY IN THE MICROCATHETER. HCP DID NOT USE AN INSTANT DETACHER. ADDITIONALLY, THE CONCERTO WAS STUCK IN THE MICROCATHETER AND THE PROCESS TO RELEASE IT COULD NOT BE STARTED. THE FIRST COIL DIAMETER OF 20MM WAS STUCK IN THE MICROCATHETER, SO HCP BEFORE USING THE SECOND CONCERTO DIAMETER 20MM FLUSHED THE MICROCATHETER A LOT BUT EVEN WITH THIS, THE SECOND CONCERTO GOT ALSO STUCK IN THE MICROCATHETER. THE PUSHWIRE WAS NOT DAMAGED AND HCP WAS VERY CAREFUL ON MOVING THE COIL GENTLY FORWARD IN THE MICROCATHETER. THIS INFORMATION WAS CONFIRMED WITH THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300519 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT IT WAS BELIEVED ONE OF THE THE 18MM COILS PREMATURELY DETACHED IN THE CATHETER, BUT IT IS NOT CERTAIN. THE MICROCATHETER WAS FLUSHED BEFORE EACH COIL, BUT THERE WAS NO CONTINUOUS IRRIGATION. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256893 ↗
• MalfunctionNov 14, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO COILS WERE TRAPPED IN THE MULTIPURPOSE DELIVERY CATHETER POSSIBLY DUE TO MISHANDLING. THE PROCE DURE WAS COMPLETED WITH INPUTS FROM THE COMPANY AND COMPETING PRODUCTS. THE IFU (INSTRUCTION FOR USE) WAS NOT FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE AS NO REBAR MICROCATHETER WAS USED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION, THE EVENT DID NOT LEAD TO OR EXTEND HOSPITALIZATION, AND THERE WAS NO INJURY. THE LESION/VESSEL SITE ASSOCIATED WITH THE EVENT WAS THE LEFT DISTAL GONADAL VEIN. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO CALCIFICATION. THE VESSEL WAS NOT PRE OR POST-DILATED. IT WAS NOTED THAT THERE WERE ABNORMALITIES IN RELATION TO ANATOMY INCLUDING PELVIC VARICOSE VEINS. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS THE PHYSICIAN DID NOT ADEQUATELY ADDRESS THE COIL WITH THE HYPOTUBE. THE RESISTANCE WAS LOCATED IN THE DISTAL SECTION. THE COILS CAME OUT OF THE INTRODUCER SHEATHS SMOOTHLY. THERE WAS A KINK/DAMAGE TO THE COILS OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687627 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COIL PUSHWIRES KINKED AND ONE OF THE COILS PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE HYPOGASTRIC REGION. THE MAX DIAMETER WAS 400MM AND THE NECK DIAMETER WAS 10MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THERE WAS A USER ERROR WHEN LOADING THE CONCERTO COIL. THE COIL WAS KINKED/DAMAGED IN THE PROXIMAL PUSHWIRE SEGMENT AND DID NOT ADVANCE ANY FURTHER, SO IT WAS REMOVED. ANOTHER COIL WAS ADVANCED AND THE PROXIMAL PUSHWIRE KINKED AND THE COIL DETACHED. THE COIL WAS ASPIRATED WITH A 3MM SYRINGE TO REMOVE IT FROM THE CATHETER. NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN DID NOT REPOSITION THE COILS DURING THE PROCEDURE, AND THERE HAD BEEN NO FRICTION/DIFFICULTY WITH EITHER COIL DURING TESTING OR DELIVERY. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269160 ↗
• MalfunctionJul 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO CONCERTO COILS THAT HAD RESISTANCE IN THE NON-MEDTRONIC MICROCATHETER; ONE OF THE COILS BROKE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INTERNAL ILIAC ARTERY TYPE 1B ENDOLEAK. BLOOD FLOW WAS NORMAL/ VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE FIRST COMPLAINT COIL (MODEL: PV-16-40-HELIX, LOT: B534527) MET RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND WAS STUCK. THE COIL BROKE AT THE HYPOTUBE/PUSHWIRE MIDDLE SEGMENT. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. DURING THE SAME PROCEDURE, ANOTHER CONCERTO COIL (MODEL: PV-20-50-HELIX, LOT: B678751) ALSO EXPERIENCED RESISTANCE DURING DELIVERY THROUGH THE MIDDLE SEGMENT OF THE MICROCATHETER. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THERE WAS NO DAMAGE TO THE MICROCATHETER. THE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: TERUMO 2.4F PROGREAT MICROCATHETER ADDITIONAL INFORMATION WAS RECEIVED THAT BOTH COILS WERE 20X50. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO MEDICAL/SUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731084 ↗
• MalfunctionAug 1, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DID NOT DETACH. DESPITE RINSING, THE COIL DID NOT PASS THROUGH THE CATHETER. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437967 ↗
• MalfunctionMar 7, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS GOT STUCK IN THE CATHETER IN THE PROXIMAL AND DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR A HYPO TAKEDOWN STAGED FOR AAA PROCEDURE. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT MULTIPLE CONCERTO COILS TRACKED SUCCESSFULLY (PV 16X4- 3D(2), PV 20X50(3), PV-14X30-HELIX(2)). THE LAST 2 PV-20-5-HELIX DID NOT TRACK AND DECIDED TO SWITCH FROM PROGREAT 2.8 TO BOSTON SCIENTIFIC RENEGADE AND THEY STILL DID NOT TRACK. REPRESENTATIVE OFFERED UP TERUMO COIL AND SUCCESSFULLY TRACKED. CASE WAS FINISHED WITH AMPLASTER PLUG. TROUBLE SHOOTING INCLUDED RE-FLUSHING THE  MICROCATHETER MANY TIMES, AND RE-FLUSHING COILS IN WATER PER IFU. THE MICROCATHETER WAS ALSO STRAIGHTENED OUT TO ENSURE DIRECT PATH FOR THE COIL. RESISTANCE OCCURRED IN THE PROXIMAL AND DISTAL SECTIONS. THE IMPLANT COILS PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE CATHETER AND COILS WERE NOT DAMAGED. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A TERUMO PROG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497103 ↗