LeVeen™ CoAccess™ M001262220Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729454922), received between Nov 2, 2017 and Jul 16, 2025 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THERE WAS DIFFICULTY DEPLOYING THE ELECTRODE. A 3.0CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN THE LIVER. OUTSIDE THE PATIENT, WHEN DEPLOYING THE ELECTRODE, UNUSUAL RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522451 ↗
• MalfunctionJan 31, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE ARRAY FAILED TO EXTEND. A 3.0CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION (RFA) PROCEDURE IN THE LIVER. DURING ATTEMPTED DEPLOYMENT, IT WAS UNABLE TO DEPLOY. THEREFORE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284161 ↗
• InjuryDec 13, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A PATIENT BURN OCCURRED. A 3CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN RADIOFREQUENCY ABLATION (RFA) PROCEDURE TO TREAT A LIVER TUMOR. THE NEEDLE WAS INSERTED PERCUTANEOUSLY THROUGH THE PATIENT'S ABDOMEN AND POSITIONED INTO THE LIVER TUMOR. ABOUT 5MINS INTO THE RFA, THE SURGEON ACTIVATED THE LEVEEN NEEDLE, WHICH RESULTED IN AN UNKNOWN ERROR MESSAGE. THE PROCEDURE HAD TO RESTART. ABOUT 3MINS INTO THE SECOND ROUND OF RFA, A BURN MARK WAS OBSERVED AT THE PUNCTURE POINT OF THE LEVEEN NEEDLE. THE PROCEDURE WAS STOPPED, AND THE LEVEEN NEEDLE WAS REMOVED. IT WAS THEN OBSERVED THAT THE LEVEEN NEEDLE WAS USED WITHOUT THE COACCESS CANNULA. USING ULTRASOUND, IT WAS DETERMINED THAT THE TARGET AREA OF THE RFA WAS NOT SATISFACTORY, AND IT WAS DECIDED TO CONTINUE WITH ANOTHER ROUND OF RFA. FOR THIS ADDITIONAL RFA TREATMENT, THE COACCESS CANNULA WAS USED TOGETHER WITH THE LEVEEN NEEDLE. THE ADDITIONAL RFA TREATMENT WENT SMOOTHLY. AFTER REMOVING THE LEVEEN COACCESS SYSTEM, THE PUNCTURE POINT WAS CHECKED, AND IT WAS DETERMINED THAT THE BURNT SKIN/TISSUE HAD TO BE REMOVED. A SMALL PORTION OF ABOUT 10-15MM IN WIDTH AND ABOUT 5MM IN DEPTH OF THE BURNT

  Patient problems: Burn(s)

  MAUDE report 20924559 ↗
• MalfunctionMay 7, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE ARRAY WAS DIFFICULT TO DEPLOY. A 3.0CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE. BEFORE STARTING THE PROCEDURE, THE NEEDLE WAS DEPLOYED TO CHECK ITS OPERATION, BUT AN UNUSUAL RESISTANCE OR STIFFNESS WAS ENCOUNTERED. THEREFORE, A DIFFERENT STOCK WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19263817 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN BURN OCCURRED. A RF3000 RADIOFREQUENCY GENERATOR AND A LEVEEN COACCESS RF PROBE WERE SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE. DURING THE PROCEDURE, THERE WERE NO ANOMALIES NOTED; HOWEVER, A SKIN BURN OCCURRED. DESPITE A HYDRO AND CARBO DISSECTION WITH A COLON DISTANCE OF 19MM, THERE WAS A COLONIC WOUND AS WELL AS A BURN TO THE SKIN 2CM IN DIAMETER. THE SEVERITY OF THE BURN WAS NOT ASSESSED. THE COLONIC WOUND ALSO RESULTED IN SEPTIC SHOCK AND STERCORAL PERITONITIS, WHICH REQUIRED A LEFT HEMICOLECTOMY WITH COLOSTOMY.

  Patient problems: Burn(s); Peritonitis; Septic Shock; Unspecified Tissue Injury

  MAUDE report 16146493 ↗
• InjuryDec 16, 2021Defective Device; Defective Device

  IT WAS REPORTED A PUNCTURE BURN OCCURRED. THE PATIENT WAS UNDERGOING A RADIOFREQUENCY ABLATION PROCEDURE IN THEIR LIVER. A LEVEEN COACCESS PROBE WAS USED WITH A RF 3000 GENERATOR. THE LEVEEN COACCESS PROBE WAS POSITIONED IN THE TUMOR SITE. IT WAS OBSERVED THAT THE ARRAY OF THE DEVICE DID NOT APPEAR TO BE HEATING UP, ONLY THE CANNULA OF THE DEVICE WAS. THE PATIENT'S SKIN BECAME BURNED. THE PROBE WAS REMOVED AND EXCHANGED FOR ANOTHER OF THE SAME. THE SECOND LEVEEN COACCESS PROBE WAS POSITIONED AND THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THE INSULATION OF THE DEVICE REMAINED INTACT UPON REMOVAL FROM THE PATIENT. THE BURN WAS THIRD DEGREE AND THE PHYSICIAN CUT THE BURN SITE TO TREAT IT. THE PATIENT WAS STABLE. IT HAS SINCE BEEN REPORTED THE WOUND IS HEALED.

  Patient problems: Burn(s)

  MAUDE report 13023414 ↗
• InjuryDec 16, 2021Defective Device; Defective Device

  IT WAS REPORTED A PUNCTURE BURN OCCURRED. THE PATIENT WAS UNDERGOING A RADIOFREQUENCY ABLATION PROCEDURE IN THEIR LIVER. A LEVEEN COACCESS PROBE WAS USED WITH A RF 3000 GENERATOR. THE LEVEEN COACCESS PROBE WAS POSITIONED IN THE TUMOR SITE. IT WAS OBSERVED THAT THE ARRAY OF THE DEVICE DID NOT APPEAR TO BE HEATING UP, ONLY THE CANNULA OF THE DEVICE WAS. THE PATIENT'S SKIN BECAME BURNED. THE PROBE WAS REMOVED AND EXCHANGED FOR ANOTHER OF THE SAME. THE SECOND LEVEEN COACCESS PROBE WAS POSITIONED AND THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THE INSULATION OF THE DEVICE REMAINED INTACT UPON REMOVAL FROM THE PATIENT. THE BURN WAS THIRD DEGREE AND THE PHYSICIAN CUT THE BURN SITE TO TREAT IT. THE PATIENT WAS STABLE. IT HAS SINCE BEEN REPORTED THE WOUND IS HEALED.

  Patient problems: Burn(s)

  MAUDE report 13023412 ↗
• MalfunctionSep 24, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE TINES WERE DIFFICULT TO EXTEND. A 3.0/15/15 LEVEEN COACCESS ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE OF A LIVER TUMOR. THE LEVEEN NEEDLE WAS INSERTED INTO THE PATIENT. SOME RESISTANCE WAS FELT, AND IT WAS NOT SMOOTH DEPLOYING THE NEEDLE. THEREFORE, THE PHYSICIAN DID NOT WANT TO USE THE DEVICE TO ABLATE THE TUMOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND IT WAS SMOOTH TO DEPLOY. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525267 ↗
• MalfunctionJul 9, 2021Failure to Unfold or Unwrap; Material Twisted/Bent; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE TINES WERE DIFFICULT TO DEPLOY. A LEVEEN COACCESS ELECTRODE SYSTEM 3.0/15/15 WAS SELECTED FOR USE IN A PROCEDURE TO TREAT A RENAL TUMOR IN THE KIDNEY. DURING THE PROCEDURE, THERE WAS RESISTANCE WHEN ATTEMPTING TO DEPLOY THE NEEDLE TINES AND THEY BECAME DISTORTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146766 ↗
• MalfunctionFeb 8, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING DEPLOYED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A RIGHT UPPER POLE RENAL TUMOR LESION OF TISSUE NATURE OF 20 MM (LONG AXIS). THE LEVEEN COACCESS WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS DEPLOYED, IT WAS REPORTED THAT IT WAS UNABLE TO BE DEPLOYED ENTIRELY. ANOTHER OF THE SAME DEVICE WAS THEN USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297784 ↗
• MalfunctionDec 22, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DIFFICULTY TO EXTEND A NEEDLE OCCURRED. A RADIOFREQUENCY ABLATION PROCEDURE WAS PERFORMED ON A LESION LOCATED IN THE PANCREAS. A 3.0 LEVEEN COACCESS ELECTRODE WAS UNPACKED, THE PATIENT WAS PUNCTURED, AND THE DEVICE WAS ADVANCED TO THE TARGET LESION, BUT THE DEVICE FAILED TO DEPLOY. AFTER THE NEEDLE ABLATION, THE NEEDLE WAS OBSERVED TO BE DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11055415 ↗
• MalfunctionOct 29, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING DEPLOYED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH CANCER. THE LEVEEN COACCESS WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS DEPLOYED AFTER PUNCTURE, IT WAS REPORTED THAT IT WAS UNABLE TO BE DEPLOYED PROPERLY. ANOTHER OF THE SAME DEVICE WAS THEN UNPACKED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759177 ↗
• MalfunctionJul 21, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING EXTENDED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH CANCER. THE LEVEEN SUPERSLIM WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS DEPLOYED AFTER PUNCTURE, IT WAS REPORTED THAT IT WAS UNABLE TO FULLY OPEN. ANOTHER OF THE SAME DEVICE WAS THEN UNPACKED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304326 ↗
• MalfunctionMar 9, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ROLL-OFF. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH LIVER CANCER. THE LEVEEN COACCESS WAS BEING USED FOR THIS PROCEDURE. THE DEVICE WAS POSITIONED IN THE PATIENT AND THE ABLATION WAS PERFORMED. THE IMPEDANCE VALUE INCREASED, BUT THE DEVICE WOULD NOT ROLL OFF EASILY. THE PROCEDURE WAS CONTINUED USING THE SAME DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS THAT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808131 ↗
• InjuryJan 19, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT A PUNCTURE BURN OCCURRED. THE PATIENT WAS UNDERGOING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE IN THEIR LUNG. A 3.0/15/15 LEVEEN COACCESS WAS USED. ACCESS WAS GAINED USING A POSTERIOR APPROACH ON THE RIGHT APICAL NODULE AND A 100W CYCLE WAS DONE FOR 1 MINUTE. THE NEEDLE WAS "ENTERED USING A FORCEPS" IN ORDER TO AVOID THERMAL LESIONS OF THE ANTERIOR PLEURA. IT WAS REPORTED THERE WAS A POSSIBLE CRACK IN THE LEVEEN COACCESS. THE PATIENT SUSTAIN A THIRD DEGREE BURN THAT APPEARED WHILE "WARMIN ON ACCROSS THA AREA IN CONTACT WITH THE METALLIC FORCEPS." THE PROCEDURE WAS INTERRUPTED. THE BURN WAS TREATED WITH A COLD WET COMPRESS (JELONET AND FLAMMAZINE). THE PATIENT WAS REFERRED TO THE SURGICAL CENTER FOR REPAIR. CONTROLLED WOUND HEALING STARTED THE FOLLOWING DAY. IT WAS FURTHER REPORTED THAT THE PHYSICIAN HELD THE NEEDLE WITH A METALLIC FORCEPS. THE ELECTRICAL CONDUCTION CAUSED THE BURN. THE PATIENT RETURNED HOME WITHOUT FURTHER INTERVENTION.

  Patient problems: Burn(s)

  MAUDE report 9604903 ↗
• MalfunctionMay 2, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE NEEDLE HAD HIGH IMPEDANCE AND EARLY ROLL-OFF. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT. THE LEVEEN COACCESS ELECTRODE WAS BEING USED FOR THIS PROCEDURE. THE NEEDLE WAS POSITIONED IN THE LESION. AT THE MOMENT OF HEATING THE LESION, THE IMPEDANCE WAS IMMEDIATELY VERY HIGH AND THERE WAS VERY EARLY ROLL-OFF. THE NEEDLE WAS REPLACED WITH ONE FROM A DIFFERENT LOT, BUT THE SAME PROBLEM OCCURRED. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED. IT WAS FURTHER REPORTED THAT THE ROLL OF WAS REACHED WITH THE SECOND NEEDLE AND NO THIRD NEEDLE WAS NEEDED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574181 ↗
• MalfunctionMay 2, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE NEEDLE HAD HIGH IMPEDANCE AND EARLY ROLL-OFF. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT. THE LEVEEN COACCESS ELECTRODE WAS BEING USED FOR THIS PROCEDURE. THE NEEDLE WAS POSITIONED IN THE LESION. AT THE MOMENT OF HEATING THE LESION, THE IMPEDANCE WAS IMMEDIATELY VERY HIGH AND THERE WAS VERY EARLY ROLL-OFF. THE NEEDLE WAS REPLACED WITH ONE FROM A DIFFERENT LOT, BUT THE SAME PROBLEM OCCURRED. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED. IT WAS FURTHER REPORTED THAT THE ROLL OFF WAS REACHED WITH THE SECOND NEEDLE AND NO THIRD NEEDLE WAS NEEDED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574158 ↗
• MalfunctionMar 19, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING EXTENDED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A PATIENT WITH KIDNEY INJURY. THE LEVEEN COACCESS WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS DEPLOYED AFTER PUNCTURE, IT WAS REPORTED THAT IT DID NOT DEPLOY PROPERLY. THE PHYSICIAN WAS CONCERNED OF NON-OPTIMAL TREATMENT, SO THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED. THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8433178 ↗
• MalfunctionOct 4, 2018Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent; Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED AND THE ARRAY WAS DAMAGED. A 3.0/15/15 LEVEEN COACCESS WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE OF THE PATIENT'S LUNG. IT WAS NOTED THAT THE TINES OF THE ARRAY DID NOT DEPLOY OR RETRACT PROPERLY RESULTING IN THEM BECOMING TWISTED. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED ONE COACCESS ELECTRODE SYSTEM WAS RECEIVED. INSPECTION VERIFIED THAT THE TIP OF UNIT WAS NOT DAMAGED, HOWEVER IT WAS RETURNED WITH THE TINES PARTIALLY OPENED. NO VISUAL DEFECTS WERE NOTED, THE RETURNED PRODUCT APPEARS IN GOOD CONDITION WITHOUT EVIDENCE OF DAMAGE OR ANOMALIES. FUNCTIONAL INSPECTION REVEALED THE HANDLE WAS ACTUATED MOVING IT FORWARD AND BACKWARD AND THE TINES OF THE RETURNED DEVICE COULD BE EXTENDED AND RETRACTED PROPERLY WITHOUT PROBLEMS OR RESISTANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7935003 ↗
• MalfunctionDec 4, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THEY WERE UNABLE TO OPEN THE TINES. A RADIOFREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED IN THE PATIENT'S LIVER. A 3.0/15/15 LEVEEN¿ COACCESS¿ WAS SELECTED AND POSITIONED IN THE PATIENT. HOWEVER, THEY WERE UNABLE TO DEPLOY THE TINE. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7078567 ↗
• MalfunctionNov 2, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THERE WAS RESISTANCE EXTENDING THE ARRAY. DURING PREPARATION, A LEVEEN¿ COACCESS¿ WAS SELECTED. WHILE CHECKING THE DEVICE, THERE WAS SEVERE RESISTANCE EXTENDING AND RETRACTING THE ARRAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6996015 ↗