pORTAL® Steerable Hydrophilic Guidewire PORT-14-200-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05391530910040), received between Jan 13, 2021 and Feb 26, 2026 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathFeb 26, 2026Fracture

  BASED ON THE LIMITED EVENT INFORMATION PROVIDED: THE GUIDEWIRE BROKE OR SNAPPED WHILE THE PHYSICIAN WAS PERFORMING A MECHANICAL THROMBECTOMY OF A BLOOD CLOT. THE BREAKAGE LED TO AN OCCLUSION IN A SMALLER BLOOD VESSEL FURTHER DOWNSTREAM DISTAL IN THE BRAIN, LIKELY BECAUSE A FRAGMENT OF THE BROKEN WIRE OR A DISPLACED CLOT BLOCKED BLOOD FLOW. ON THE (B)(6) 2025, PHENOX LTD RECEIVED MORE INFORMATION REGARDING THE EVENT INVOLVING PORTAL GUIDEWIRE: EVENT DESCRIPTION AS DESCRIBED BY THE COMPLAINANT: A PATIENT WITH AN ACUTE ISCHEMIC STROKE UNDERWENT MECHANICAL THROMBECTOMY VIA RIGHT FEMORAL ACCESS. INITIAL CATHETER NAVIGATION WAS DIFFICULT DUE TO A SEVERE ANATOMICAL LOOP IN THE LEFT INTERNAL CAROTID ARTERY, PREVENTING FULL ADVANCEMENT OF THE ASPIRATION CATHETER. PROCEDURE: A LONG 7F 70 CM FLEXOR SHEATH CATHETER WAS INTRODUCED FOR SELECTIVE CATHETERIZATION OF THE LEFT INTERNAL CAROTID ARTERY, BUT ITS LENGTH WAS INSUFFICIENT TO REACH THE PROXIMAL SEGMENT OF THE LEFT ICA. AFTER DIAGNOSTIC IMAGING, THE DIAGNOSTIC BERENSTEIN 5F CATHETER WAS EXCHANGED FOR A LONG 7F FLEXOR SHEATH POSITIONED AT THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY, USING A 0.35 HYDROPHILIC GUIDEWIRE (STIFF 260 CM). CONTI

  Patient problems: Foreign Body Embolism

  MAUDE report 24455336 ↗
• InjuryJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOWING THE COMPLICATION DURING THE ENDOVASCULAR PROCEDURE ,WHERE A PORTION OF THE PORTAL GUIDEWIRE (DISTAL SEGMENT) DETACHED AND REMAINED WITHIN THE INTERNAL CAROTID ARTERY-THE PHYSICIAN TOOK IMMEDIATE REMEDIAL STEPS TO ENSURE PATIENT SAFETY AND COMPLETE THE TREATMENT WITHOUT ADVERSE OUTCOMES. THE DETACHED SEGMENT OF THE MICROGUIDE WAS PROMPTLY IDENTIFIED AS RESIDING IN THE CEREBRAL VASCULATURE (MIDDLE CEREBRAL ARTERY), . THE PHYSICIAN ATTEMPTED 3 INTERVENTIONAL TECHNIQUES TO RETRIEVE THE RETAINED FRAGMENT: AN INFLATED BALLOON WAS USED IN AN ATTEMPT TO DISLODGE AND WITHDRAW THE GUIDE SEGMENT. SNARE CATHETER RETRIEVAL FOR MECHANICAL CAPTURE. A STENT RETRIEVER WAS DEPLOYED AS A FINAL MANEUVER, WHICH SUCCESSFULLY RETRIEVED THE RETAINED FRAGMENT. SOFIA DISTAL ACCESS CATHETER AND NEURON MAX SHEATH SUPPORTED PROCEDURAL SUCCESS. BASED ON THE INITIAL INFORMATION PROVIDED - THE PATIENT EXPERIENCED NO NEUROLOGICAL DEFICITS, INDICATING THAT THE REMEDIAL ACTIONS WERE EFFECTIVE AND DID NOT COMPROMISE PATIENT SAFETY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22479890 ↗
• InjuryJul 2, 2025Break; Break

  INITIAL EVENT AS REPORTED: IT WAS REPORTED THAT A MICROGUIDE 0.014 PORTAL, WAS BROKEN INSIDE A VASCO 10 MICROCATHETER AND BECAME AN INTRAVASCULAR FOREIGN BODY IN THE CEREBRAL ARTERIES. THE REASON FOR TREATMENT WAS CEREBRAL EMBOLIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JUN-2025 AS REQUESTED BY THE MANUFACTURER: PRIOR TO THE PROCEDURE, THE ENTIRE GUIDEWIRE WAS SUFFICIENTLY HYDRATED IN PHYSIOLOGICAL SOLUTION IN ACCORDANCE WITH THE DEVICE'S INSTRUCTIONS FOR USE (IFU). THE TIP WAS SHAPED USING THE PROVIDED INSERTION TOOL BEFORE USE. NO DAMAGE, SUCH AS KINKS, WAS NOTED ON THE GUIDEWIRE BEFORE THE PROCEDURE. THE GUIDEWIRE WAS NOT REMOVED OR REINSERTED DURING THE PROCEDURE, AND THEREFORE WAS NOT RE-EXAMINED OR WIPED WITH GAUZE AT ANY POINT. THE USER DID NOT EXPERIENCE RESISTANCE DURING EITHER ADVANCEMENT OR RETRACTION OF THE GUIDEWIRE. THERE WAS NO ADVANCEMENT OR WITHDRAWAL AGAINST RESISTANCE WITHIN THE PATIENT'S ANATOMY, AND THE GUIDEWIRE WAS NOT EXCESSIVELY ROTATED DURING NAVIGATION. THE PROCEDURE WAS CONDUCTED UNDER CONTINUOUS FLUOROSCOPIC MONITORING. AN ANCILLARY DEVICE, A VASCO 10 MICROCATHETER (BALT), WAS USED IN CONJUNCTION WITH THE GUIDEWIRE. THIS MICROCATHETER WAS HYDRAT

  Patient problems: Insufficient Information

  MAUDE report 22383093 ↗
• InjuryDec 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT WITH AN ACOM ANEURYSM AND TORTUOUS VESSELS WAS TREATED WITH PORTAL STEERABLE HYDROPHILIC GUIDEWIRE. A 6F GUIDING CATHETER AND A COMPETITOR MICROCATHETER WERE ALSO USED DURING THE PROCEDURE. IT WAS REPORTED THAT, DURING THE PROCEDURE, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE FOUND. BOTH GUIDEWIRE AND MICROCATHETER WERE HYDRATED BEFORE USE. THE DEVICE DISTAL END WAS WIPED USING CLOTH/GAUZE BEFORE USE. NO ABNORMAL RESISTANCE WAS EXPERIENCED WHEN ADVANCING OR RETRACTING THE DEVICE. THE PHYSICIAN DID THE PUNCTURE, PLACED THE INTRODUCER, RAISED THE CATHETER AND PASSED THE PORTAL GUIDEWIRE, WHICH NAVIGATED VERY EASILY. BUT HALFWAY THROUGH THE PROCEDURE, PHYSICIAN NOTICED THAT THE CATHETER HAD MOVED AWAY FROM THE LOCATION. AN ATTEMPT WAS MADE TO CROSS FROM LEFT A1 TO RIGHT A2 WITH THE MICROCATHETER AND THE PORTAL, BUT BECAUSE THE GUIDING CATHETER WAS UNSTABLE DUE TO THE CERVICAL TORTUOSITY, THE GUIDEWIRE WAS DISLOCATED FROM POSITION. THEN IT WAS DECIDED TO START THE PROCEDURE AGAIN. THE CATHETER WAS NAVIGATING WHEN THE GUIDEWIRE BROKE. THE POSITION OF THE DISTAL TIP WAS AT A1 AND THE BROKEN PROXIMAL PART WAS AT THE PETROUS SEGMENT OF THE ICA.THE PHYSICIAN MANAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311434 ↗
• InjurySep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING DESCRIPTION WAS PROVIDE FROM THE HEALTHCARE PROFESSIONAL: "THEY STARTED TO USE THE PORTAL, AND BEFORE REACHED THE LESION, REALIZED THAT THE GUIDE WIRE PORTAL HAD BROKEN IN HALF. THEY DIDN'T PUSH OR DID ANY PRESSION AND FEEL ANY KINKING BECAUSE THE ANATOMY WASN'T COMPLEX. THEY TRIED TO PULL IT OUT WITH A SOLITAIRE, A SNARE AND IT DIDN'T WORK. THEY ENDED UP USING A DERIVO´S FLOW DIVERTER. THE PATIENT WAS HOSPITALISED FOR 1 DAY, AS USUAL." DURING THE PROCEDURE, ONE PORTAL GUIDEWIRE WAS USED AND, BEFORE THE DEVICE REACHED THE LESION, IT WAS NOTED THAT THE PORTAL WIRE HAD BROKEN IN HALF. A MICROCATHETER WAS ALSO USED DURING THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS NOT PUSHED AND NO PRESSURE WAS ADDED. KINKING WAS NOT FELT AS PATIENT'S ANATOMY WAS NOT COMPLEX. AN ATTEMPT WAS MADE TO REMOVE THE DETACHED PORTION OF THE DEVICE USING A THROMBECTOMY RETRIEVER AND SNARE BUT THE ATTEMPT WAS NOT SUCCESSFUL. A FLOW DIVERTER DEVICE WAS THEN USED AND THE DETACHED PART OF THE PORTAL DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO PROLONGATION OF PATIENT HOSPITALIZATION AND NO FURTHER INJURY WAS REPORTED. THE ADDITIONAL INFORMATION WILL BE OBTAINED, AND INVESTIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17841578 ↗
• MalfunctionJan 13, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  THIS IS A FOLLOW UP REPORT - SEE INTINAL REPORT FOR THIS INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164795 ↗