CERENOVUS ENTERPRISE ENF453712Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886704044048), received between Apr 14, 2017 and Sep 15, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X37MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453712, 8945944) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31597980) COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-SEP-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER KINKED/BENT. THERE WERE NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052047 ↗
• MalfunctionSep 15, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403000, 9020409) WAS IMPEDED IN INTRODUCER, AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-SEP-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (606-S255X, 31586957). THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS NOT PROLONGED/DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051382 ↗
• MalfunctionSep 8, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY, A 4.5X37 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 12MM DW TIP (ENC453712, 8598548) WAS IMPEDED IN INTRODUCER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY ADDED A LITTLE FORCE TO DELIVER THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN Y CONNECTOR. THE DOCTOR REMOVED THE Y CONNECTOR AND REMOVED THE STENT AND THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993026 ↗
• MalfunctionSep 4, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING ENDOVASCULAR EMBOLIZATION, A 4.5X37MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 12 MM DW TIP (ENC453712, 8945944) WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO A PROWLER SELECT PLUS MICROCATHETER. THE DOCTOR ONLY REMOVED THE STENT ALONE AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION STATES THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THE INTRODUCER WAS SUCCESSFULLY FLUSHED PRIOR TO THE EVENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE DELIVERY WIRE WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963848 ↗
• MalfunctionAug 21, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X37 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453712, 9294564) WAS IMPEDED IN THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31567760) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED A SECOND MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (606S255X, 31567760) TO DELIVER THE ORIGINAL STENT, BUT THE ORIGINAL STENT WAS WITH THE SAME ISSUE. THE DOCTOR REMOVED THE SECOND MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO A THIRD NEW MICROCATHETER AND A SECOND STENT TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 35 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-AUG-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 35-MINUTE PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861717 ↗
• MalfunctionAug 19, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X37MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453712, 9493895) WAS IMPEDED IN PROXIMAL OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31540340) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED A SECOND NEW STENT, A 4.5X37MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453712, 9508480). THE SECOND STENT HAD THE SAME ISSUE. THE DOCTOR TRIED TO RETRACT THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER HUB. THE DOCTOR REMOVED THE MICROCATHETER AND THE SECOND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-AUG-2025 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839754 ↗
• MalfunctionAug 6, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4.5X28MM STENT 12 MM DW TIP (ENC452812, 9584139) IMPEDED IN MICROCATHETER HUB AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO THE SECOND STENT OF THE SAME PRODUCT CODE AND IMPLANTED IT SUCCESSFULLY. THE DOCTOR DELIVERED A THIRD STENT, AN ENTERPRISE2 4.5X37MM STENT 12 MM DW TIP (ENC453712, 9493895) WHICH ALSO BECAME IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31557192) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE THIRD STENT AND THE MICROCATHETER (MC) FROM THE PATIENT, THEN SWITCHED A SECOND MICROCATHETER AND IMPLANTED A FOURTH STENT IN TARGET SITE (THE SECOND STENT AND THE FOURTH STENT WERE PARTIALLY NESTED TOGETHER). THE SURGERY WAS PROLONGED BY ABOUT 15 MINUTES. THE PATIENT PRESENTED STENOSIS IN THE C6-C7 OF THE INTERNAL CAROTID ARTERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUL-2025 INDICATED THAT NO TORQUE DEVICE WAS USED. IT WAS CLARIFIED THAT THE STENT PARTIALLY OVERLAPPED. THE 15 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728261 ↗
• MalfunctionAug 5, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X37MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453712, 8645715) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31359810) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED BY ABOUT 15 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUL-2025 INDICATED THAT NO TORQUE WAS APPLIED. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 15 MINUTES PROCEDURE DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717358 ↗
• MalfunctionJul 21, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X37MM STENT 12 MM DW TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453712, 8546185) WAS IMPEDED IN PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31557192) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE; IT WAS FOUND THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED A NEW STENT AND A NEW MICROCATHETER (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-JUL-2025 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS PROLONGED BY FIVE MINUTES; HOWEVER, THE DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554772 ↗
• MalfunctionJul 7, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X37MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453712, 8645715) WAS IMPEDED IN THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31471104) COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND THEN SWITCHED TO A SECOND NEW MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (LOT UNKNOWN) AND DELIVERED THE ORIGINAL STENT, BUT THE STENT WAS STILL IMPEDED IN THE DISTAL END OF MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND THE SECOND MICROCATHETER FROM THE PATIENT, IT WAS FOUND THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR SWITCHED TO A SECOND STENT TO COMPLETE THE SURGERY WITH THE SECOND MICROCATHETER. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JUL-2025 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414339 ↗
• MalfunctionJan 22, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X37MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC453712, 8945944) BECAME IMPEDED IN THE PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31392027) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN TRIED TO RETRACT THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC). THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCH NEW DEVICES TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 20-JAN-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE EVENT DID NOT PROLOG THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209464 ↗
• MalfunctionJan 13, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X37MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC453712, 8945944) BECAME IMPEDED IN PROXIMAL OF AN UNSPECIFIED MICROCATHETER (MC) COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED OUT THE STENT ALONE, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 13-JAN-2025 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THE PROCEDURE WAS DELAYED BY 5 MINUTES, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138024 ↗
• MalfunctionDec 12, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY PROCEDURE, AN EU 4.5X37MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC453712, 8878726) BECAME IMPEDED IN DISTAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR ONLY RETRACTED OUT THE STENT AND FOUND THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DOCTOR SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916191 ↗
• MalfunctionOct 14, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X37MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC453712, 8598548) BECAME IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, UNKNOWN LOT) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND REPLACED A NEW STENT AND USED THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-OCT-2024 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK OR BENT. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439891 ↗
• MalfunctionAug 27, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY FOR CAROTID ARTERY STENOSIS, AN EU 4.5X37MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC453712, 8697547) BECAME IMPEDED IN Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT AND IT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31328289) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-AUG-2024 INDICATED THAT NO EXCESSIVE FORCE WAS USED WITH THE DEVICE. THE DEVICE WAS NOT TORQUED. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077293 ↗
• MalfunctionApr 14, 2017Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE STRONG RESISTANCE WAS EXPERIENCE WHEN USING AN ENTERPRISE STENT (ENF453712/10485322) AND PROWLER CATHETER (UNKNOWN LOT). THE PROCEDURE WAS FOR TREATMENT OF AN ANTERIOR COMMUNICATING SACCULAR ANEURYSM, THE VESSEL WAS NOT EXCESSIVELY TORTUROUS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING THE ENTERPRISE STENT THROUGH THE DISTAL SECTION OF THE PROWLER SELECT PLUS MICROCATHETER. IT WAS REPORTED THAT THE COMPLAINT ENTERPRISE STENT WAS REMOVED ALONG WITH THE PROWLER CATHETER AND EXCHANGED FOR A NEW STENT. IT WAS REPORTED THAT THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB; AND DID NOT MOVE FORWARD OUT OF THE INTRODUCER INTO THE HUB DURING INSERTION. THERE WERE NO DAMAGES NOTED ON THE STENT OR THE PROWLER CATHETER PRIOR TO USE OR UPON REMOVAL. THERE WERE NO OTHER DEVICES USED WITH THE PROWLER CATHETER. THERE WAS NO DIFFICULTY DURING INTRODUCTION OF THE CATHETER OVER THE GUIDEWIRE PRIOR TO THE ATTEMPTED USE OF THIS STENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WERE OTHER DEVICES USED WITH THE PROWLER CATHETER WITHOUT DIFFICULTY. THERE WERE NO ADVERSE EVENTS OR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6493658 ↗