N/A 46419 (UDI 00613994806628)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994806628), received between Dec 15, 2016 and Oct 30, 2019 — classified as 1 death, 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2019Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PORTION OF THE BROKEN CATHETER REMAINED INSIDE THE PATIENT. THE CATHETER WAS NOT ABLE TO BE RETRIEVED; HOWEVER, THERE WAS NO MENTION OF IT CAUSING A PROBLEM IN THE FUTURE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9256699 ↗
• MalfunctionMay 17, 2019Break; Break

  IT WAS REPORTED THE DEVICE WAS DEFECTIVE. IT WAS STATED THE GUIDEWIRE BIFURCATION INTO A FILAMENT COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PRODUCT WAS BROKEN UPON OPENING THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8621369 ↗
• MalfunctionFeb 15, 2019Fracture; Fracture

  IT WAS REPORTED THE LUMBAR CATHETER GOT CUT OFF IN A PATIENT BY THE TROCAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346150 ↗
• InjuryDec 12, 2018Fracture; Fracture

  IT WAS REPORTED THE PATIENT HAD A LUMBAR DRAIN PLACED, BUT IT WAS NOT INTERNALLY ANCHORED. ON THE FIFTH POST-OPERATIVE DAY, THE DRAIN WAS DISCONTINUED. WHILE PULLING THE DRAIN SLOWLY, MODERATE RESISTANCE WAS MET. WITH CONTINUED PULLING, THE DRAIN WAS REMOVED AND THE TIP WAS NOTED TO BE SHEARED. A LUMBAR MRI VERIFIED THE RETAINED CATHETER IN THE PARASPINAL MUSCULATURE AT THE L4-L5 LEVEL. THE PATIENT RETURNED TO THE OPERATING ROOM TWO DAYS LATE FOR REMOVAL OF THE CATHETER FRAGMENT. THE SURGEON NOTED THAT THE CATHETER DID NOT APPEAR TO BE ENTANGLED OR ANCHORED. AN 18MM OPAQUE CATHETER TIP (FRAGMENT) WAS EXAMINED AND NOTED TO BE TORN AT THE SITE OF THE CATHETER PERFORATION FOR DRAINAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156579 ↗
• MalfunctionJul 10, 2018Break; Fracture; Material Separation; Fracture

  IT WAS REPORTED THAT A LUMBAR DRAIN WAS BEING PLACED BY THE DOCTOR IN INTERVENTIONAL RADIOLOGY. DURING THE PLACEMENT OF THE CATHETER, IT BROKE OFF INSIDE THE PATIENT DURING THE ADJUSTMENT OF IT. THE SEPARATION (BREAKAGE) OF THE CATHETER HAPPENED JUST BELOW THE SURFACE TISSUE OF THE BACK, MAYBE AN INCH. THE DOCTOR ATTEMPTED TO RETRIEVE IT BUT WAS UNABLE TO. SINCE IT WAS ANOTHER DOCTOR'S PATIENT, THE DOCTOR PERFORMING THE PROCEDURE CONSULTED THE SITUATION WITH THEM, AND THE PATIENT'S DOCTOR AND NURSE PRACTITIONER PROCEEDED TO COME TO THE BIPLANE AND HELP RETRIEVE IT. IT WAS STATED THEY WERE SUCCESSFUL. EVERY PART OF THE CATHETER WAS RETRIEVED AND NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7673613 ↗
• MalfunctionJun 26, 2018Break; Detachment Of Device Component

  LUMBAR DRAIN WAS BEING PLACED BY DR. IN INTERVENTIONAL RADIOLOGY. DURING THE PLACEMENT OF THE CATHETER, IT BROKE OFF INSIDE THE PATIENT DURING THE ADJUSTMENT OF IT. THE SEPARATION (BREAKAGE) OF THE CATHETER HAPPENED JUST BELOW THE SURFACE TISSUE OF THE BACK (MAYBE AN INCH?). DR. 1 ATTEMPTED TO RETRIEVE IT BUT WAS UNABLE TO. BEING DR. 2'S PATIENT, DR. 1 CONSULTED THE SITUATION WITH HIM AND DR. 2 AND NP PROCEEDED TO COME TO THE BIPLANE AND HELP RETRIEVE IT AND WERE SUCCESSFUL. EVERY PART OF THE CATHETER WAS RETRIEVED AND NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7637353 ↗
• MalfunctionFeb 9, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT BOTH CATHETERS "SPLIT' DURING AN ATTEMPTED INSERTION. IT WAS CONFIRMED THAT THE 3RD CATHETER WAS INSERTED SUCCESSFULLY AFTER A 3 MINUTE DELAY AND THE PROCEDURE PROCEEDED AS PLANNED. THERE WAS NO STAFF OR PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7259595 ↗
• DeathJul 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS NOT HAVING SURGERY AT THE TIME OF THEIR DEATH. IT WAS STATED THERE HAD BEEN NO ALLEGATION THAT THE DEATH WAS RELATED TO THE PRODUCT.

  Patient problems: Death; Hydrocephalus

  MAUDE report 6750595 ↗
• InjuryApr 28, 2017Break; Device Or Device Fragments Location Unknown; Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE LUMBAR DRAIN WAS INSERTED IN THE CONTEXT OF AN EMERGENCY THORACIC ENDOVASCULAR ANEURYSM REPAIR. ACCORDING TO THE REPORT, THE PATIENT WAS IN A LATERAL POSITION AND AWAKE DURING INSERTION. THE INSERTION OF THE TUOHY NEEDLE WAS STRAIGHTFORWARD AND IDENTIFICATION OF BEING IN THE SUBARACHNOID SPACE WAS WITH FREE FLOWING CEREBROSPINAL FLUID (CSF). IT WAS STATED THAT WHEN THE DEVICE AND GUIDEWIRE WERE PRELOADED TO THE TIP OF THE DRAIN AND INSERTED THROUGH THE TUOHY NEEDLE, THEY ENCOUNTERED RESISTANCE. ON WITHDRAWING THE DEVICE, IT WAS NOTICED THAT THE END SHEARED OFF LEAVING A DISTAL PART OF THE DEVICE WITHIN THE PATIENT. REPORTEDLY, THERE WAS A CONSENSUS DECISION NOT TO REPEAT THE DRAIN INSERTION BUT PROCEED WITH THE CASE WHICH LED TO A DELAY OF 30-45 MINUTES. IT WAS STATED THE PROCEDURE WAS SUCCESSFUL UNDER GENERAL ANESTHESIA, AND THE PATIENT WAS TRANSFERRED AND AWAKE TO THE INTENSIVE CARE UNIT (ICU) FOR NEUROLOGICAL MONITORING. RESIDUAL DRAIN IN CSF WAS DISCUSSED, BUT NO FURTHER INVESTIGATION OR ACTIONS WERE REQUIRED AS THE PATIENT WAS NEUROLOGICALLY INTACT. HOWEVER, THE PATIENT SUBSEQUENTLY DIED FROM LIKELY UNRELATED ILLNESS. POSTMORT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6532124 ↗
• MalfunctionDec 27, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WAS LEAKING OUT OF THE DISTAL PORTION AFTER INSERTION. ACCORDING TO THE REPORT, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6207643 ↗
• MalfunctionDec 21, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER RUPTURED INTRAOPERATIVELY. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6197425 ↗
• MalfunctionDec 15, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER TIP BROKE UPON INSERTION. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179634 ↗