VenaCure EVLT 11403101Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI H787114031010), received between Jul 27, 2015 and Feb 3, 2026 — classified as 11 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Fracture” (26 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. DURING THE EVLT PROCEDURE, THE FIBER FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. THIS REQUIRED AN ADDITIONAL INCISION TO REMOVE THE FRAGMENT. THE PHYSICIAN REPORTED THAT HE FOLLOWED THE ESTABLISHED PROCEDURE AND USED THE FIBER INTRODUCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24250884 ↗
• MalfunctionFeb 3, 2026Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. DURING THE EVLT PROCEDURE, THE FIBER FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. THIS REQUIRED AN ADDITIONAL INCISION TO REMOVE THE FRAGMENT, HOWEVER THE ATTEMPT TO REMOVE THE FRAGMENT WAS UNSUCCESSFUL AND THE FRAGMENT WAS RETAINED IN THE SAPHENOFEMORAL JUNCTION. THE PHYSICIAN REPORTED THAT HE HAD FOLLOWED THE ESTABLISHED PROCEDURE AND USED THE FIBER INTRODUCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 24250883 ↗
• MalfunctionFeb 3, 2026Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVER TOUCH DIRECT PROCEDURE KIT. DURING THE EVLT PROCEDURE, THE FIBER FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. IT WAS NOT ORIGINALLY NOTICED BY THE PHYSICIAN THAT THE TIP HAD FRACTURED OFF INSIDE OF THE PATIENT. THE PATIENT LATER PRESENTED WITH SIGNIFICANT HYPEREMIA IN HER THIGH. THE PHYSICIAN MADE AN INCISION, WHERE THE FIBER FRAGMENT WAS FOUND AND REMOVED. THE PHYSICIAN REPORTED THAT HE HAD FOLLOWED THE ESTABLISHED PROCEDURE AND USED THE FIBER INTRODUCER. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 24250881 ↗
• MalfunctionSep 17, 2025Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. PHYSICIAN PULLED THE LASER FIBER THROUGH THE SHORT ACCESS SHEATH. HE THEN TRIED TO REMOVE THE SHEATH TO CONTINUE THE PROCEDURE, BUT THE SHEATH BROKE NEAR THE HUB. ROUGHLY 8CM OF THE SHEATH REMAINED IN THE PATIENT. THE DOCTOR SUCCESSFULLY REMOVED THE BROKEN SHEATH FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. IT WAS REPORTED THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074319 ↗
• MalfunctionSep 2, 2025Fracture; Fracture

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. DURING THE PROCEDURE, WITH ABOUT 25CM LEFT TO FINISH THE SAPHENE VEIN OF THE RIGHT LEG, THE FIBER BROKE. THE DOCTOR WASN'T FORCING, SHE WAS PERFORMING THE PROCEDURE AS INSTRUCTED. THE PATIENT HAD NO TORTUOSITY IN THIS REGION OF THE LEG. WHEN THE FIBER BROKE, THE TIP OF THE FIBER WAS LEFT OUTSIDE THE INTRODUCER, MAKING IT EASIER TO REMOVE. THEY OPENED A 2ND FIBER TO FINISH THE REMAINING 25CM, AND PERFORMED THE ABLATION ON THE LEFT LEG.

  Patient problems: Foreign Body In Patient

  MAUDE report 22943689 ↗
• InjuryFeb 25, 2025Melted; Melted

  ADDITIONAL INFORMATION RECEIVED VIA USER FACILITY MEDWATCH, REFERENCE MW5168431, REPORTED THAT THE FIBER MELTED AND BROKE INTO TWO PIECES, WHILE INSIDE OF THE PATIENT'S VEIN. PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE THE FOREIGN BODY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461844 ↗
• MalfunctionJul 15, 2024Thermal Decomposition of Device; Detachment of Device or Device Component; Thermal Decomposition of Device; Detachment of Device or Device Component

  A PHYSICIAN REPORTED AN ISSUE WITH A NEVERTOUCH DIRECT PROCEDURE KIT. THE FOLLOWING WAS REPORTED: "WHILE TREATING THE ANTERIOR SAPHENOUS VEIN WITH NEVERTOUCH DIRECT, DR. (B)(6) FORGOT TO REMOVE THE SHEATH AT THE 16CM (B)(6) CLAIMS HE DID NOT SEE MARKING AND DURING PULLBACK OF THE SHORT VEIN SEGMENT, BURNED THE SHEATH AND A FRAGMENT, OF THE SHEATH, WAS LEFT IN THE VEIN WHEN REMOVING LASER FIBER AND MELTED SHEATH. (B)(6) CALLED ME AT 3:56PM WITH THE PATIENT IN ROOM TO EXPLAIN WHAT HAPPENED. I IMMEDIATELY CALLED THE CLINICAL (B)(6) AND HAD A THREE-WAY CALL WITH THE PHYSICIAN. WE DISCUSSED HOW NEVERTOUCH DIRECT RETAINED CATHETER FRAGMENT. (B)(6) SPOKE WITH THE PHYSICIAN WHO INDICATED THAT HE LOST TRACK OF THE WARNING MARKS AND INADVERTENTLY PULLED THE LASER FIBER INTO THE SHEATH. (B)(6) HAD ADVISED THE PHYSICIAN THAT THE FRAGMENT SHOULD BE RETRIEVED AND POSSIBLE CUTDOWN SINCE THE FRAGMENT WAS SUPERFICIAL AND END OF THE TREATED ASV. THE PHYSICIAN LATER CALLED THE TM AND INDICATED HE WAS ABLE TO RETRIEVE THE FRAGMENT." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT AND DID NOT REQUIRE ANY ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 19742520 ↗
• MalfunctionFeb 1, 2024Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  A NURSE REPORTED AN ISSUE WITH A NEVERTOUCH DIRECT FIBER . IT WAS REPORTED THAT THE FIBER "BROKE" WHEN ATTACHED TO LASER GENERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621520 ↗
• MalfunctionApr 28, 2023Fracture; Fracture

  AT THE START OF THE PROCEDURE, WHEN OPENING THE NEVERTOUCH DIRECT PROCEDURE KIT KIT, THE FIBER APPEARED AS EXPECTED. WHEN THE FIBER WAS INSERTED INTO THE PATIENT'S VEIN, THERE WERE NO NOTED ISSUES. THE PROVIDER STARTED THE BURN, WITH THE UNIT SHOWING ENERGY, HOWEVER, THE FIBER WAS NOT BURNING AS EXPECTED. THE PROVIDER REMOVED THE FIBER, AT WHICH TIME THE FIBER BROKE INTO THREE PIECES. IT WAS REPORTED THAT NO PART OF THE FIBER HAD BEEN RETAINED INSIDE THE PATIENT, THEREFORE NO ADDITIONAL INTERVENTION WAS NEEDED SUCH AS CUT DOWN OR SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE/KIT. IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832755 ↗
• MalfunctionSep 20, 2022Fracture; Fracture

  ADDITIONAL EVENT INFORMATION: THE DOCTOR SELF-TREATED THE BURN, WHICH WAS REPORTED TO BE A VERY SMALL, PINPOINT BURN. THE DOCTORT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: Burn(s)

  MAUDE report 15454524 ↗
• MalfunctionAug 5, 2022Melted; Detachment of Device or Device Component; Device Markings/Labelling Problem; Melted; Detachment of Device or Device Component; Device Markings/Labelling Problem

  WHEN USING A NEVERTOUCH DIRECT FIBER FIBER, IT WAS NOTICED THE 16CM WARNING MARKER WAS MISSING. THE DOCTOR CONTINUED TO USE THE FIBER, RESULTING IN THE INTRODUCER SHEATH BEING LASED INSIDE THE PATIENT'S VEIN. DUE TO THIS ISSUE, THE PROCEDURE WAS TERMINATED. THE DOCTOR CHECKED THE PATIENT UNDER ULTRASOUND AFTER THE PROCEDURE BUT DID NOT SEE ANY REMNANTS OF THE SHEATH. HE THEN ORDERED A CT SCAN FOR THE PATIENT, WHICH SHOWED THE SHEATH TIP HAD DETACHED INSIDE THE PATIENT'S DISTAL GSV. ADDITIONAL INFORMATION PROVIDED REPORTED THE PATIENT IS DOING WELL, AND THE SHEATH TIP WAS RETAINED IN THE PATIENT'S CALF.

  Patient problems: Foreign Body In Patient

  MAUDE report 15173500 ↗
• MalfunctionAug 5, 2022Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR FIBER. WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE FIBER INTO THE MACHINE, IT BROKE IN HALF. A NEW FIBER WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173499 ↗
• MalfunctionMay 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ANSM (FRANCE NATIONAL COMPETENT AUTHORITY) NOTIFIED ANGIODYNAMICS OF AN EVENT THAT OCCURRED WITH A LASER FIBER FROM A NEVER TOUCH DIRECT PROCEDURE KIT. THE END USER HAD REPORTED THAT DURING A PROCEDURE, THE TIP OF THE FIBER BECAME LOOSE. THE FIBER WAS EXCHANGED FOR A NEW OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315005 ↗
• MalfunctionJan 14, 2022Fracture; Fracture

  A DISTRIBUTOR REPORTED AN ISSUE WITH A NEVER TOUCH DIRECT PROCEDURE KIT. WHILE PERFORMING THE BURNING PROCEDURE FOR THE PATIENT, THE DOCTOR DISCOVERED THAT THE FIBER WAS BROKEN INSIDE THE PATIENT FOR A LENGTH (ABOUT 32CM). HE WAS ABLE TO REMOVE THE BROKEN PIECE OF FIBER FROM THE PATIENT'S LEG. NO ERROR CODES HAD DISPLAYED ON THE BURNING DEVICE AT THE TIME. THE REMOVAL WAS CARRIED OUT WITHOUT BEING TOO COMPLICATED, THEN THE DOCTOR USED A NEW KIT TO BURN THE PATIENT AGAIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13257978 ↗
• MalfunctionDec 15, 2021Fracture; Fracture

  A DISTRIBUTOR REPORTED AN ISSUE WITH A NEVER TOUCH DIRECT PROCEDURE KIT. DURING A PROCEDURE, THE FIBER BROKE AND THE PART OF THE FIBER, WITH THE GOLDEN TIP, IS RETAINED IN THE PATIENT'S LEG. THE DOCTOR REPORTED THAT THE PATIENT WILL HAVE TO PERFORM A SEPARATE SURGERY IF THE DECISION IS MADE TO REMOVE THE FIBER TIP FROM THE PATIENT'S LEG. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13011303 ↗
• MalfunctionNov 2, 2021Fracture; Fracture

  A PHYSICIAN ASSISTANT REPORTED AN ISSUE WITH A NEVERTOUCH DIRECT PROCEDURE KIT. DURING A PROCEDURE, AT THE TIME OF THE LAST SECTION OF LASING, THE FIBER SPONTANEOUSLY BROKE AFTER A CRACKLING SOUND AND SMALL FLAME WAS NOTED. THIS OCCURRED OUTSIDE OF THE PATIENT'S BODY; THEREFORE, THE PATIENT WAS UNAFFECTED BUT THE PA SUFFERED A "FAIRLY SUPERFICIAL" BURN TO A THUMB. PART OF THE FIBER WAS STILL INSERTED, BUT STICKING OUT OF THE INSERTION SITE, SO THE REMAINING FIBER WAS ABLE TO BE PULLED OUT FULLY INTACT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque; Superficial (First Degree) Burn

  MAUDE report 12736984 ↗
• MalfunctionSep 1, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A NEVERTOUCH DIRECT PROCEDURE KIT. WHILE UNPACKING, IT WAS NOTED THAT THE FIBER WAS BENT. ANOTHER SAME DEVICE WAS OPENED TO PROCEED WITH THE FOLLOWING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT WITH THE AFFECTED PRODUCT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408371 ↗
• MalfunctionJul 1, 2021Fracture; Fracture

  A NURSE REPORTED AN ISSUE WITH A NEVERTOUCH DIRECT PROCEDURE KIT. DURING PULLBACK, THE FIBER BROKE AROUND THE 8CM MARK, DISTALLY FROM THE TIP. THE PATIENT'S GSV (22CM) WAS TREATED BUT THE FIBER FRACTURED WITH 9CM REMAINING TO BE TREATED AFTER THE FIRST FIRING. THE RETAINED PORTION OF THE FIBER PROTRUDED THROUGH THE PATIENT'S SKIN ON THEIR UPPER LEG, AT THE INSERTION SITE ("THE FIBER FRACTURED SHORT BEFORE STICKING OUT AT THE INSERTION POINT"). THE VASCULAR SURGEON BURNED HIS THUMB AND FINGER. THE BURN WAS SUPERFICIAL AND DID NOT REQUIRE MEDICAL TREATMENT. THE FRACTURED PART COULD EASILY BEEN REMOVED. DUE TO THIS EVENT, THE PROCEDURE WAS NOT CONTINUED. THE PATIENT REMAINED CALM UNDER THE INCIDENT AND DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THE PROTRUSION. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12102196 ↗
• MalfunctionJun 9, 2021Fracture; Fracture

  A DISTRIBUTOR REPORTED AN ISSUE WITH A NEVERTOUCH DIRECT PROCEDURE KIT. THE FOLLOWING WAS REPORTED: NORMAL USE OF THE NT DIRECT FIBRE WITH A SMALL SAPHENOUS VEIN. AT PROCEDURE CLOSURE, WHEN PULLING BACK THE LAST 10 CM, THE FIBER FRACTURED. NO PART OF THE FIBER REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967875 ↗
• MalfunctionOct 19, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT DURING THE PULL BACK OF THE EVLT NEVERTOUCH DIRECT LASER, APPROXIMATELY 8CM OF THE FIBER BROKE OFF INSIDE THE PATIENT. SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE DEVICE FROM THE PATIENT. OTHER THAN REQUIRING MEDICAL INTERVENTION, THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10702050 ↗
• InjuryJul 21, 2020Fracture; Fracture

  AN END USER REPORTED AN ISSUE THAT OCCURRED DURING AN ABLATION PROCEDURE WHEN USING A NEVERTOUCH DIRECT FIBER KIT, THE FIBER SNAPPED DURING THE PROCEDURE, WITHIN THE PATIENT'S VEIN. STAFF WERE ABLE TO OBTAIN THE BROKEN FIBER AND THE PATIENT DID NOT EXPERIENCE ANY HARM OR ADVERSE EVENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10304162 ↗
• InjuryJun 23, 2020Melted; Melted

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED BEING INFORMED OF AN INCIDENT INVOLVING A NEVERTOUCH DIRECT PROCEDURE KIT. IT WAS REPORTED THAT, DURING AN EVLT PROCEDURE, THE INTRODUCER SHEATH WAS BURNT INSIDE OF THE PATIENT'S VEIN, CAUSING THE SHEATH TO BE SEVERED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO HAVE THE SHEATH SURGICALLY REMOVED FROM HER VEIN. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10184369 ↗
• InjuryNov 21, 2019Fracture; Fracture

  AS REPORTED: NEVERTOUCH FIBER BURNED AND FRACTURED AROUND 14 CM FROM THE TIP. DISTAL PART HAD TO BE SURGICAL REMOVED. FIRST TREATED WAS A AASV WITH 3200 JOULE. AFTER THIS PROCEDURE THE DOCTOR WANTED TO TREAT THE SSV AND THE FIBER FRACTURED AFTER STARTING FIRING. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9355744 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AT THE CLOSING OF AN EVLT PROCEDURE, IT WAS NOTED THE GOLD TIP HAD DETACHED FROM THE LASER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY DUE TO THE IS EVENT. IT WAS INDICATED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575004 ↗
• MalfunctionApr 2, 2019Fracture; Fracture

  DURING PREPARATION FOR THE PROCEDURE, WHEN OPENING THE STERILE PACKAGING, IT WAS NOTED THE LASER FIBER BROKEN IN HALF AND INTRODUCER SHEATH WAS DEFORMED/KINKED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474751 ↗