Hermetic™ INS5010Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10381780071082), received between Nov 8, 2016 and Aug 6, 2026 — classified as 16 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Difficult to Remove; Physical Resistance/Sticking

  N/A

  Patient problems: Insufficient Information

  MAUDE report 50161278 ↗
• MalfunctionApr 24, 2026Complete Blockage; Physical Resistance/Sticking

  AN AUTHORIZED DISTRIBUTOR REPORTED THAT LUMBAR DRAIN ACCESS WAS SUCCESSFULLY INSERTED, YET UPON REMOVAL OF THE LUMBAR CATHETER STYLET, THERE WERE SOME DIFFICULTIES WHILE REMOVING THE GUIDEWIRE OR THE STYLET. WHEN MORE FORCE WAS APPLIED TO REMOVE THE STYLET, IT CAME OUT OF THE CATHETER, BUT IT WAS LOOSE AND THINNER, SO THEY REMOVED THE CATHETER AND USED A NEW ONE AND THE SAME PROBLEM HAPPENED. THEY TRIED FOR THE THIRD TIME, AND IT HAPPENED AGAIN; HOWEVER THEY KEPT THE THIRD CATHETER INSIDE AND DECIDED TO TRY TO DRAIN, BUT IT WASN'T DRAINING PROPERLY. THEY THEN DECIDED TO STOP AND REPORT THE INCIDENT. ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR: 1. END USER FACILITY? ANSWER: NEUROSURGERY CONSULTANT, (B)(6). 2. IS IT POSSIBLE TO HAVE AN ESTIMATION OF TIME INCREASE? IS IT LESS OR MORE THAN 30 MINUTES? ANSWER: YES, MORE THAN 30 MINUTES. 3. WERE THERE ANY ADDITIONAL CONSEQUENCES FOR THE PATIENT? ANSWER: NO. 4. COULD THE MEDICAL TEAM USE (NORMALLY) OR THEY HAVE TO INSERT ANOTHER ONE? ANSWER: THEY INSERTED TWO NEW CATHETERS, AND THEY COULDN'T DRAIN PROPERLY. 5. COULD YOU PLEASE LET US KNOW IF THE DEVICE OR THE DAMAGED PART IS AVAILABLE FOR INVESTIGATION? ANSWER: NOT REPORTED YET,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984998 ↗
• MalfunctionApr 24, 2026Disconnection

  A FACILITY REPORTED THAT THE YELLOW CONNECTOR WAS NOT SEALED ON THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010), AND AS A CONSEQUENCE, THERE WAS LEAKAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24984370 ↗
• MalfunctionMar 31, 2026Physical Resistance/Sticking

  A FACILITY REPORTED THAT DURING PLACEMENT OF A DSE (DRAINAGE SYSTEM EXTENSION) CATHETER UNDER STERILE CONDITIONS, THREE PUNCTURES WERE PERFORMED. AND THE EPIDURAL SPACE WAS IDENTIFIED AT THE L3-L4 LEVEL. CEREBROSPINAL FLUID (CSF) OUTFLOW UNDER PRESSURE WAS OBSERVED, CONSISTENT WITH THE PATIENT'S KNOWN SUBARACHNOID HEMORRHAGE (SAH). THE MANDREL-REINFORCED CATHETER WAS ADVANCED WITHOUT DIFFICULTY, AND THE INTRODUCER NEEDLE WAS REMOVED UNEVENTFULLY. UPON REMOVAL OF THE MANDREL, THE MANDREL FRACTURED, WITH THE BRAIDED WIRES UNRAVELING AND TWO WIRES SNAPPING, RESULTING IN DAMAGE TO THE DISTAL PORTION OF THE CATHETER. THE MANDREL WAS FULLY REMOVED; THE DISTAL 10-12 CM APPEARED INTACT ON INSPECTION. AS A PRECAUTION, THE PHYSICIAN CUT THE CATHETER AT THE LEVEL OF THE FISSURE/BREAK BEFORE CONNECTING THE CATHETER TO THE CSF DRAINAGE COLLECTION SYSTEM USING THE PROVIDED CONNECTOR. THE CATHETER WAS WET BUT NOT FULLY PRIMED WITH FLUID PRIOR TO USE. THE MANDREL WAS NOT WRAPPED AROUND THE OPERATOR'S FINGERS OR HAND DURING WITHDRAWAL. THE INCIDENT RESULTED IN A SIGNIFICANT INCREASE IN PROCEDURE TIME OF APPROXIMATELY 1 HOUR. HOWEVER, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742094 ↗
• InjuryMar 7, 2026Disconnection

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 2648988-2026-00006: MEDWATCH "MW5182169" WAS RECEIVED WITH THE FOLLOWING INFORMATION: "INTEGRA HERMETIC LUMBAR CATH. CLOSED TIP INS5010 AND INTEGRA DRAINAGE SYSTEM INS8401 LUMBAR DRAIN INSERTED AND DRESSING PLACED OVER SITE. CONNECTION BETWEEN LUMBAR CATHETER AND DRAINAGE SYSTEM WAS NOT WITHIN THE DRESSING. THE TUBING OF THE LUMBAR CATHETER BECAME DISCONNECTED FROM THE CONNECTION POINT. TUBING PULLED FREE OF CONNECTION POINT MALE ADAPTER THAT THEN CONNECTS TO DRAINAGE SYSTEM TUBING. UNCLEAR HOW IT BECAME DISCONNECTED AS IT WAS REPORTED TO BE FUNCTIONAL WITH LAST ASSESSMENT. UPON NEXT ASSESSMENT DRAINAGE SYSTEM FOUND TO HAVE NO NEW OUTPUT, AIR FOUND IN TUBING, AND TUBING DISCONNECTED AT CONNECTION POINT MALE ADAPTER. PATIENT DEVELOPED PNEUMOCEPHALUS REQUIRING SURGICAL INTERVENTION WHICH WAS COMPLETED A PLANNED PROCEDURE WHICH WAS MOVED UP DUE TO PNEUMOCEPHALUS. CEREBROSPINAL FLUID LEAK DUE TO HEAD TRAUMA, HISTORY OF CRANIOTOMY. PT-4587, DEVICE-2900. REFERENCE REPORTS - MW5182170. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED AS FOLLOWS: 1. PLEASE PROVIDE THE REPORTING FACILITY NAME. (B)(6). 2. PLEASE PROVIDE THE COMPLETE ADDRESS

  Patient problems: Cerebrospinal Fluid Leakage; Pneumocephalus

  MAUDE report 24540402 ↗
• MalfunctionDec 29, 2025Disconnection; Disconnection

  A FACILITY REPORTED THAT A PATIENT WITH LUMBAR DRAINAGE AFTER AN ANTERIOR COMMUNICATING ARTERY ANEURYSM EXPERIENCED ACCIDENTAL DISCONNECTION OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) FROM THE COLLECTION SYSTEM, LEADING TO REMOVAL OF THE CATHETER DUE TO INFECTION RISK. IMAGING SHOWED VENTRICULAR ENLARGEMENT, AND A NEW LUMBAR CATHETER WAS INSERTED. RISKS INCLUDED EXCESSIVE CSF LOSS IF UNNOTICED AND INFECTION. THE CONNECTION BETWEEN THE CATHETER AND THE COLLECTION SYSTEM APPEARED INSUFFICIENTLY SECURED. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED AS FOLLOWS: "THE COLLECTION SYSTEM USED IS THE VENTREX COMPLETE EVD SYSTEM FROM NEUROMEDEX (REF: (B)(4)). HOWEVER, THE MALFUNCTION DOES NOT OCCUR AT THE JUNCTION BETWEEN THE CATHETER AND THE COLLECTION SYSTEM. THE MALFUNCTION IS UPSTREAM, ENTIRELY ON THE INTEGRA SYSTEM. IN PRACTICE, AFTER INSERTING THE DRAINAGE CATHETER, WE INSERT A CONNECTOR INTO IT THAT WILL ALLOW IT TO CONNECT THE FLEXIBLE CATHETER TO THE NEUROMEDEX SYSTEM. THE ACCIDENTAL DISCONNECTION OCCURRED THERE IN OUR CASE."

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 23917252 ↗
• MalfunctionOct 24, 2025Complete Blockage; Complete Blockage

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23383517 ↗
• MalfunctionOct 9, 2025Difficult to Insert; Difficult to Insert

  AN AUTHORIZED DISTRIBUTOR REPORTED THAT IT WAS DIFFICULT TO INSERT THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) THROUGH THE TUOHY NEEDLE, AS IF THE CATHETER HAD LOST ITS ELASTICITY. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: 1. FOR HOW LONG DID THE DYSFUNCTION LEAD TO INCREASE SURGERY TIME? ANSWER: IT TOOK MORE THAN AN HOUR TO SECURE THE LUMBER DRAIN (STERILE TECHNIQUE BEFORE SURGERY). 2. HOW DID THE MEDICAL TEAM FINISH THE PROCEDURE (USING THIS UNIT OR ANOTHER ONE¿)? ANSWER: DRAIN INSERTED AS PLANNED PREOP. WITH DIFFICULTIES, DIFFICULT TO PASS THE SILICON DRAIN INTO SPINAL NEEDLE CATHETER (RESISTANCE) AND, AT THE END, SO DIFFICULT TO REMOVE THE SPINAL NEEDLE WHILE THE CATHETER IS IN THE SPINE, RISKING PUNCTURING THE SILICON TUBE OR CAUSING ITS FRACTURE. 3. HOW IS THE PATIENT NOW? ANSWER: HE IS FINE, HOWEVER, THE TEAM DIDN'T LIKE THE LUMBAR DRAIN EXPERIENCE, AND I FEEL IT IS SO RISKY, ESPECIALLY IF THE DRAIN FRACTURE AND PIECE LEFT INTRASPINAL. 4. END USER HEALTHCARE FACILITY? ANSWER: PRINCE SULTAN MILITARY MEDICAL CITY IN (B)(6) (SAUDI ARABIA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23259913 ↗
• MalfunctionOct 9, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE TIP OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) WAS CUT BY THE TUOHY NEEDLE DURING INSERTION, AND THAT THE ISSUE OCCURRED WITH 2 DIFFERENT PATIENTS. THEY TRIED TO RETRIEVE THE OTHER END (AS IT GOT STUCK INSIDE) AND HAD TO DO ANOTHER TRIAL OF INSERTION. THE PATIENT WAS REPORTED AS "SYMPTOMATIC", BUT THE NATURE OF THE SYMPTOMS HAVE NOT BEEN REPORTED. THE DYSFUNCTION LED TO INCREASED SURGERY TIME OF AN HOUR. END USER HEALTHCARE FACILITY: (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 23259900 ↗
• MalfunctionSep 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  A FACILITY REPORTED THE FOLLOWING: "THE DOCTOR PERFORMED A DSE CATHETER PLACEMENT ON PATIENT (FEMALE). AFTER EASILY IDENTIFYING THE SUBDURAL SPACE, THE DOCTOR INSERTED THE GUIDEWIRE (AFTER ADEQUATELY LUBRICATING IT WITH SALINE TO ALLOW FOR BETTER SLIDING). THE PROGRESSION WAS SMOOTH, SO THE DOCTOR REMOVED THE METAL NEEDLE AND BEGAN TO EXTRACT THE GUIDEWIRE WITH ONE HAND, HOLDING THE CATHETER STEADY WITH THE OTHER. THE DOCTOR FELT RESISTANCE AND NOTICED A CURLING OF THE CATHETER AT THE DISTAL END, A SENSATION NOT DIFFERENT FROM PREVIOUS PLACEMENTS. UPON REMOVAL OF THE WHOLE CATHETER, A BREAKAGE OF THE CATHETER'S MANDREL WAS EVIDENT. THE MANDREL APPEARED TO BE MADE OF SEVERAL INTERTWINED WIRES, ONE OF THEM APPEARED TO BE UNTANGLED AND CUT. THE MANDREL, HOWEVER, WAS INTACT AT THE END. THE DOCTOR DID NOT NOTICE ANY LESIONS OR ABNORMAL LEAKAGE OF CEREBROSPINAL FLUID FROM THE CATHETER." ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: - COULD YOU PLEASE CLARIFY THIS STATEMENT "UPON REMOVAL OF THE WHOLE CATHETER, A BREAKAGE OF THE CATHETER'S MANDREL WAS EVIDENT." WAS THE CATHETER REMOVED COMPLETELY, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE? OR WAS THE CATHETER'S MANDREL (GUIDEWIRE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983897 ↗
• MalfunctionJul 18, 2025Difficult to Advance; Difficult to Advance

  A FACILITY REPORTED THAT DURING TEVAR PROCEDURE, THE GUIDEWIRE PERFORATED THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) ON INSERTION. THE DOCTOR FELT RESISTANCE ON INSERTION OF LUMBAR CATHETER; IT WAS A CHALLENGING INSERTION WITH DIFFICULTY FEEDING THE CATHETER WITH HIGH RESISTANCE. DUE TO THE AMOUNT OF RESISTANCE ENCOUNTERED, THE DOCTOR WITHDREW THE CATHETER, AND IT WAS THEN NOTED THAT THE GUIDE WIRE HAD PERFORATED THE TIP OF THE CATHETER. THE DOCTOR REINSERTED ANOTHER LUMBAR CATHETER WITHOUT ISSUE. THE SURGERY WAS DELAYED FOR 60 MINUTES DUE TO THE PROBLEM ENCOUNTERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549391 ↗
• MalfunctionJun 20, 2025Disconnection; Disconnection

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 2648988-2025-00024. A FACILITY REPORTED THAT A PATIENT WAS TREATED FOR EVACUATION OF A LEFT TEMPORAL INTRAPARENCHYMAL HEMATOMA FOLLOWING A MECHANICAL FALL WITH HEAD TRAUMA. ON (B)(6), THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR EXTERNAL LUMBAR CEREBROSPINAL FLUID (ESF) DRAIN INSERTION EARLY IN THE NIGHT. UPON RETURNING TO THE ROOM, THE DRAIN TUBING BECAME MISMATCHED, RESULTING IN A POOL OF CEREBROSPINAL FLUID (CSF) IN THE BED (CONNECTED TO THE COMPLETE VENTRICULAR DRAINAGE SYSTEM (EVD REF: (B)(4), LOT: 412147, CORMEDICA => ANOTHER BRAND). THE DRAIN WAS CLAMPED AND RE-FITTED IN THE ROOM WITHOUT CHANGING THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302436 ↗
• InjuryJun 10, 2025Entrapment of Device; Entrapment of Device

  N/A.

  Patient problems: Foreign Body In Patient

  MAUDE report 22180714 ↗
• MalfunctionJun 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  A FACILITY REPORTED THAT DURING PLACEMENT OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS500), THE OPERATOR WAS UNABLE TO REMOVE THE RIGID GUIDEWIRE, WHICH GRADUALLY FRAYED UNTIL IT BROKE, RESULTING IN FAILURE OF THE EXTERNAL LUMBAR SHUNT DEVICE. A NEW PUNCTURE WAS REQUIRED, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE LASTED A TOTAL OF ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: HOW IS THE PATIENT DOING NOW? ANSWER: THE INCIDENT HAS NOT YET CAUSED ANY HARM TO THE PATIENT, AND THEIR CURRENT CONDITION IS UNRELATED TO THE INCIDENT OBSERVED. I AM UNABLE TO PROVIDE YOU WITH FURTHER INFORMATION ON THE PATIENT'S HEALTH. PROVEN CONSEQUENCES: ANSWER: DOUBLE SPINAL PUNCTURE AND PROLONGED MANIPULATION IN A PATIENT WITH INTRACRANIAL HYPERTENSION REQUIRING A BOLUS OF BARBITURATE + 20% NACL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180236 ↗
• MalfunctionMay 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  A FACILITY REPORTED THAT A HERMETIC LUMBAR CATHETER (INS5010) WAS POSITIONING TO THE PATIENT, AND AFTER HAVING EASILY IDENTIFIED THE SUBDURAL SPACE, THE GUIDE WIRE WAS INSERTED (AFTER HAVING ADEQUATELY LUBRICATED IT WITH SALINE SOLUTION TO ALLOW FOR BETTER SLIDING). THE PROGRESSION WAS FLUID, THE METAL NEEDLE WAS REMOVED, AND EXTRACTION BEGAN WITH ONE HAND WHILE HOLDING THE CATHETER FIRMLY WITH THE OTHER HAND. THERE WAS RESISTANCE WITH THE CATHETER CURLING IN THE DISTAL PART. UPON REMOVAL OF THE ENTIRE CATHETER, A BREAKAGE OF THE CATHETER SPINDLE ITSELF WAS EVIDENT. THE SPINDLE APPEARS TO BE MADE OF SEVERAL INTERTWINED WIRES OF WHICH ONE APEX SEEMED TO BE UNTWISTED AND CUT. THE SPINDLE WAS; HOWEVER, INTACT AND IN THE FINAL PART. NO LESIONS OR ABNORMAL LEAKS OF LIQUOR FROM THE CATHETER ITSELF WAS NOTICED. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: ¿ NO PATIENT INJURED. ¿ INCREASE OF SURGERY TIME :1 HOUR. ¿ PRODUCT IS LOST, SO THEY DO NOT KNOW LOT/DEADLINE AND THEY WILL NOT RETURN THE CATHETER. ¿ THE PATIENT HAD NO LESIONS DUE TO THE PROBLEM AND THE SURGERY WAS NOT DELAYED. THEY HAD TO REPOSITION A NEW CATHETER THOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061224 ↗
• MalfunctionMay 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 2648988-2025-00015: A FACILITY REPORTED THAT THE GUIDEWIRE OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) FAILED. THE DRAIN WAS FLUSHED AND INSERTED WITH THE WIRE INSIDE, AND WHEN THEY TRIED TO REMOVE THE WIRE, IT GOT STUCK AND THE WIRE UNRAVELED. THEY KEPT PULLING TILL IT CAME OUT BUT IT WAS DAMAGING THE DRAIN IN SOME SPOTS. IT IS UNKNOWN IF THERE WAS PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: "THERE WAS ROUGHLY A 10 MIN DELAY FOR THE CASE. AND WE JUST PULLED ON THE WIRE THAT WAS FALLING APART, AND IT EVENTUALLY CAME OUT AFTER CAUSING SOME DAMAGE TO PART OF THE DRAIN CATHETER (WHICH WE CUT OFF AT THE END)."

  Patient problems: Insufficient Information

  MAUDE report 22027385 ↗
• MalfunctionMay 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT IS 2 OF 2 AND LINKED TO MFG REPORT NUMBER 2648988-2025-00016: A FACILITY REPORTED THAT THE GUIDEWIRE OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) FAILED. THE DRAIN WAS FLUSHED AND INSERTED WITH THE WIRE INSIDE, AND WHEN THEY TRIED TO REMOVE THE WIRE, IT GOT STUCK AND THE WIRE UNRAVELED. THEY KEPT PULLING TILL IT CAME OUT BUT IT WAS DAMAGING THE DRAIN IN SOME SPOTS. IT IS UNKNOWN IF THERE WAS PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: "THERE WAS ROUGHLY A 10 MIN DELAY FOR THE CASE. AND WE JUST PULLED ON THE WIRE THAT WAS FALLING APART, AND IT EVENTUALLY CAME OUT AFTER CAUSING SOME DAMAGE TO PART OF THE DRAIN CATHETER (WHICH WE CUT OFF AT THE END)."

  Patient problems: Insufficient Information

  MAUDE report 22027348 ↗
• MalfunctionMay 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A

  Patient problems: Insufficient Information

  MAUDE report 22008762 ↗
• InjuryMay 8, 2025Fracture; Fracture

  A FACILITY REPORTED THAT DURING THE PROCESS OF REMOVAL OF HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010), THE TIP OF THE DRAIN FRACTURED AND WAS RETAINED INSIDE THE PATIENT. AN IMMEDIATE CT LUMBAR SPINE SHOWED THE TIP OF THE DRAIN ADJACENT TO THE SPINOUS PROCESS, IN THE FASCIAL SPACE. THE PATIENT WAS REVIEWED IMMEDIATELY AND WAS CLINICALLY STABLE AND WELL. THE DECISION WAS MADE TO REMOVE THE REMNANT TIP, AND IT WAS REMOVED UNDER LOCAL ANESTHETIC AND SEDATION. THE PATIENT REMAINS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21987097 ↗
• MalfunctionApr 3, 2025Disconnection; Disconnection

  A FACILITY REPORTED THE FOLLOWING REGARDING THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010): "DISCONNECTION OF THE CATHETER FROM THE DELIQUORATION SET FOR A NON-PRESSURE CATHETER LUMEN AND NO STOP APPLIED AN EXTERNAL SUTURE THREAD WITHOUT BENEFIT." ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED WITH THE FOLLOWING INFORMATION: COULD YOU PLEASE CONFIRM THAT THE ISSUE WAS THAT THE CATHETER DISCONNECTED FROM THE BAG OF CSF EVEN IT WAS SUTURED PROPERLY AND THERE WAS NO TENSION ON IT? YES DATE THE CATHETER WAS INSERTED? (B)(6)2025. DATE THE CATHETER WAS DISCOVERED DISCONNECTED? (B)(6) 2025. WHICH ACTION WAS DONE TO RESOLVE THE ISSUE (CHANGE THE CATHETER, NEW SUTURES¿)? CATHETER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766616 ↗
• InjuryApr 3, 2025Material Fragmentation; Material Fragmentation

  MEDWATCH (MW5167197) WAS RECEIVED WITH THE FOLLOWING INFORMATION: "TIP OF THE LUMBAR DRAIN CATHETER SHEARED WHEN BEING INTRODUCED AND A TIP OF THE CATHETER WAS RETAINED IN THE SPINE." IT IS UNKNOWN IF THE TIP STILL REMAINS IN THE SPINE; HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21766108 ↗
• MalfunctionApr 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THAT DURING INSERTION OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) IN AN EMERGENCY IN THE OPERATING ROOM, WHEN THE CATHETER WAS IN PLACE, THE SURGEON OBSERVED LEAK BECAUSE OF A SMALL DROP ON THE SURFACE. THEY REMOVED THE CATHETER AND INSERTED A SIMILAR NEW ONE FROM A DIFFERENT LOT, AND THERE WAS NO ISSUE WITH THE SECOND CATHETER. INCREASED SURGERY TIME WAS LESS THAN 30 MINUTES WITH NO ADVERSE CONSEQUENCE FOR THE PATIENT. HOWEVER, THERE WAS AN INFECTIOUS RISK TO PATIENT IF THE ISSUE WAS NOT DETECTED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764834 ↗
• MalfunctionMar 27, 2025Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  A FACILITY REPORTED THAT THE HERMETIC LUMBAR CATHETER (INS5010) WAS USED IN A PROCEDURE WITHOUT INCIDENT, HOWEVER, WHEN REMOVING THE GUIDEWIRE, IT BEGAN TO FRAY, AND THE FRAYING CAUSED MULTIPLE CATHETER TEARS. THERE WAS MINIMAL DELAY. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY INDICATING THE FOLLOWING: 1. IT WAS REPORTED THAT THE FRAYING CAUSED MULTIPLE CATHETER TEARS. DID THE DAMAGE CATHETER WAS REMOVED? -- THE DISTAL PORTION OF THE CATHETER THAT HAD TEARS WAS CUT PROXIMALLY TO THE TEARS, ONCE I SAW IT WAS LEAKING CSF. THE CATHETER WAS NOT REMOVED FROM THE PATIENT AS IT WAS STILL FUNCTIONAL AND DID NOT SEEM LIKE IT TORE AT ANY POINT MORE PROXIMAL TO THE PATIENT. 2. HOW DID THEY FINALIZE PROCEDURE? DID THEY HAVE TO PERFORM A NEW PROCEDURE TO INSERT A NEW CATHETER? -- A NEW CATHETER WAS NOT INSERTED. 3. WAS THERE ANY ANATOMICAL FEATURE, CONDITION, AND OR ANOMALY THAT COULD MAKE DIFFICULT THE GUIDEWIRE REMOVAL? -- NO, WE ARE USUALLY ABLE TO PLACE THESE CATHETERS IN SIMILAR PATIENTS WITHOUT ISSUE. FOR EXAMPLE, MRI L SPINE ON THIS PATIENT SHOWS NO CENTRAL CANAL STENOSIS, NO BONY METASTASIS, MINIMAL L5-S1 ANTEROLISTHESIS, JUST BILATERAL L5 PARS INTERARTICULARIS DEFECT. 4. WAS THE

  Patient problems: Foreign Body In Patient

  MAUDE report 21708957 ↗
• MalfunctionMar 13, 2025Difficult to Remove; Difficult to Remove

  A FACILITY REPORTED THAT WHILE REMOVING THE GUIDE WIRE, IT BEGAN TO UNRAVEL INSIDE THE HERMETIC LUMBAR CATHETER (INS5010). THERE WAS SURGICAL DELAY OF 90 MINUTES; HOWEVER, NO PATIENT INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602069 ↗
• MalfunctionJan 16, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  A FACILITY REPORTED THE FOLLOWING CONCERNING THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010): ¿PATIENT WITH POST-TRAUMATIC STRESS INTRACRANIAL HYPERTENSION. INDICATION FOR EXTERNAL LUMBAR DERIVATION FOR EARLY INTRACRANIAL HYPERTENSION DESPITE SEDATION. SIMPLE PUNCTURE OF THE DURAL CUL-DE-SAC BY TROCAR AND MANDREL. FRANK REFLEX OF CSF. PRE-MOISTENED GUIDE EVD. ASCENSION WITHOUT DIFFICULTY THROUGH THE TROCAR OF THE EVD CATHETER WITH ITS METAL GUIDE OF APPROXIMATELY 15 CM. WHEN ATTEMPTING TO REMOVE THE GUIDE, IT RUBS ABNORMALLY. AFTER OBTAINING 2-3 CM OF WITHDRAWAL, THE FRICTION IS SIGNIFICANT WHICH DEFORMS THE PROXIMAL END OF THE CATHETER WHICH BECOMES SERPIGINOUS. THEN THE GUIDE DISINTEGRATES WITH PERSISTENCE OF THE METAL CORE IN THE KT OF EVD AND THEN BREAKS. THE CATHETER IS CUT AT A DISTANCE OF APPROXIMATELY 15 CM FROM THE SKIN TO ALLOW SUBCUTANEOUS TUNNELING. NO CSF EXIT. PERSISTENCE IN THE CATHETER OF THE DISTAL END OF THE GUIDE. REMOVAL OF THIS DISTAL END WITH FORCEPS WHICH RESTORES SATISFACTORY CATHETER PERMEABILITY. IMMEDIATE ACTION: REMOVAL OF THIS DISTAL END WITH FORCEPS WHICH RESTORES. GOOD FLOW THROUGH THE CATHETER. DEVICE KEPT FOR ANALYSIS.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175739 ↗