FATHOM™ -14 M001508110Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 08714729801030), received between Sep 19, 2018 and Aug 24, 2026 — classified as 14 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Detachment of Device or Device Component; Difficult to Advance

  It was reported that tip detachment occurred.The patient underwent transcatheter internal iliac artery embolization for bladder hemorrhage. A 200cm x 10cm Fathom-14 guidewire was selected for use. However, during the procedure, while advancing the guidewire through the microcatheter under digital subtraction angiography (DSA) guidance, the tip of the guidewire remained stationary despite multiple attempts to advance it. The guidewire and microcatheter were withdrawn together. Upon external inspection, it was noted that the guidewire tip was detached. The device was removed, and the procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that the target lesion was non-stenosed, non-tortuous, and non-calcified.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50400843 ↗
• MalfunctionJul 28, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059834 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, UPON UNPACKING, IT WAS DISCOVERED THAT THE OUTER MEMBRANE OF THE DEVICE WAS PARTIALLY TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816725 ↗
• MalfunctionDec 15, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19NOV2025. IT WAS REPORTED THAT TIP OF THE GUIDEWIRE WAS BENT AND KINKED. A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE IN THE ABDOMINAL CAVITY FOR A PERITONEOGRAPHY. DURING THE PROCEDURE, THE GUIDEWIRE ENTERED THE SHEATH, AND IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE BENT AND KINKED AND COULD NOT BE SMOOTHLY DELIVERED. THE GUIDEWIRE WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PTFE COATING AT THE PROXIMAL SECTION OF THE GUIDEWIRE WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810175 ↗
• MalfunctionOct 30, 2025Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02OCT2025. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE FOR INTERVENTIONAL THERAPY FOR LIVER CANCER. DURING ADVANCING, THE WIRE WAS NOT SMOOTH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DETACHMENT AT THE DISTAL TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427524 ↗
• MalfunctionSep 22, 2025Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 200CM X 10CM GW FATHOM-14, ANGLED TIP GUIDEWIRE WAS SELECTED FOR EMBOLIZATION OF INTRACRANIAL ANEURYSM. DURING THE PROCEDURE, THE DISTAL END OF THE GUIDEWIRE WAS FRACTURED WHEN IT REACHED THE MIDDLE CEREBRAL ARTERY. THE LENGTH OF THE FRACTURED GUIDEWIRE WAS APPROXIMATELY 7CM. THE GUIDEWIRE WAS SIMPLY PULLED OUT, AND THE FRACTURED GUIDEWIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110020 ↗
• MalfunctionAug 21, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28AUG2025. IT WAS REPORTED THAT DEVICE DIFFICULT TO TRACK OVER WIRE AND TIP DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL CAVITY. A 200CM X 10CM FATHOM-14 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN GUIDEWIRE ENTERED THE LESION. THE TIP WAS WEAK AND COULD NOT GUIDE. THE GUIDEWIRE WAS WITHDRAWN, AND IT WAS NOTED THAT THE TIP WAS TORTUOUS AND DEFORMED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DISTAL TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866076 ↗
• MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP OF THE GUIDEWIRE BECAME SEPARATED AND REMAINED UNRETRIEVED INSIDE THE PATIENT'S BODY. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LIVER. A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR TRANSARTERIAL CHEMOEMBOLIZATION (TACE). HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE BECAME SEPARATED WITHIN THE PATIENT'S BLOOD VESSEL AFTER SUPERSELECTION. THE SEPARATED TIP REMAINED UNRETRIEVED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, AFTER THE PATIENT UNDERWENT DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND THE TARGET BLOOD VESSEL WAS IDENTIFIED, DURING THE PROCESS OF SUPER-SELECTING THE TARGET BLOOD VESSEL WITH FATHOM, THE BLOOD VESSEL CANNOT BE SUPER-SELECTED DUE TO ITS COMPLEX AND TORTUOUS NATURE. WHEN THE FATHOM WIRE WAS WITHDRAWN, ABOUT 5 CM OF THE TIP BROKE OFF. THE DISTAL PART OF THE FATHOM WIRE WAS WITHDRAWN, AND ABOUT 5 CM OF THE TIP REMAINED IN THE ABERRANT RIGHT HEPATIC ARTERY OF THE SUPERIOR MES

  Patient problems: Foreign Body In Patient

  MAUDE report 22591535 ↗
• MalfunctionJul 22, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JUN2025. IT WAS REPORTED THAT CATHETER KINK OCCURRED. A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE. DURING PROCEDURE, THE CATHETER BODY WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569975 ↗
• MalfunctionMay 13, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT AND DEVICE ENTRAPMENT OCCURRED. A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE IN A PROCEDURE TO TREAT A GASTROINTESTINAL BLEED. DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE AND GOT STUCK IN THE DISTAL END OF THE TRUSELECT CATHETER. THE WIRE WAS ABLE TO BE REMOVED FROM THE MICROCATHETER ONCE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ORIGINAL METHOD AND/OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009739 ↗
• MalfunctionApr 4, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GUIDEWIRE COATING ISSUE OCCURRED. THE PROCEDURE INVOLVED ACCESSING A STENOSED TARGET LESION LOCATED IN THE INTRACRANIAL REGION. FOR THIS PURPOSE, A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED. DURING THE INSERTION PROCESS, IT WAS OBSERVED THAT THE GUIDEWIRE HAD DEVELOPED CREASES, AND ITS COATING HAD FLAKED OFF. DUE TO THESE ISSUES, THE ORIGINAL GUIDEWIRE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774178 ↗
• MalfunctionJan 21, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2024. IT WAS REPORTED THAT THE TIP OF THE GUIDE WIRE WAS TORTUOUS. THE TARGET LESION WAS LOCATED IN THE CELIAC ARTERY. A FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE IN A CELIAC ARTERIOGRAPHY. DURING THE PROCEDURE, THE TIP OF THE GUIDE WIRE WAS TORTUOUS, AND THE INTRODUCTION COULD NOT BE PERFORMED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED POLYMER JACKET DETACHED/PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200803 ↗
• MalfunctionDec 10, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE COATING WAS WAVY. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE. DURING INSERTION, THE COATING SEEMED UNEVEN AND NOT SMOOTH. MOREOVER, THE WIRE COULD NOT CROSS THE MICROCATHETER, A GREAT RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE WIRE WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893413 ↗
• MalfunctionDec 5, 2024Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2024. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A 200CM X 10CM FATHOM -14 WAS SELECTED FOR USE IN A TRANSCATHETER HEPATIC ARTERY EMBOLIZATION. HEPARIN SALINE PERFUSION AND CONTINUOUS IRRIGATION WERE PERFORMED IN THE WHOLE PROCESS. DURING INSERTION, THE TIP OF THE GUIDE WIRE WAS TORTUOUS AND COULD NOT BE GUIDED NORMALLY. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE TIP OF THE GUIDEWIRE WAS BENT AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856578 ↗
• MalfunctionDec 5, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON(B)(6) 2024. IT WAS REPORTED THAT DEVICE KINK OCCURRED. A 200CM X 10CM FATHOM -14 WAS SELECTED FOR TRANSCATHETER HEPATIC ARTERY EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE GOT KINKED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED COATING PEELED AT POLYMER JACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855516 ↗
• MalfunctionOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN ENTERED INTO THE PATIENT'S BODY, IT WAS NOTED THAT THE GUIDEWIRE WAS FRACTURED. ADDITIONALLY, THE GUIDEWIRE WAS STUCK TO THE CATHETER. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516916 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. TWO 200CM X 10CM FATHOM -14 WERE SELECTED FOR YTTRIUM-90 (Y90) DELIVERY. HOWEVER, DURING INSERTION, IT WAS NOTED THAT BOTH TIPS OF THE GUIDEWIRES SHEARED INSIDE THE TRUSELECT MICROCATHETER. THE DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441081 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. TWO 200CM X 10CM FATHOM -14 WERE SELECTED FOR YTTRIUM-90 (Y90) DELIVERY. HOWEVER, DURING INSERTION, IT WAS NOTED THAT BOTH TIPS OF THE GUIDEWIRES SHEARED INSIDE THE TRUSELECT MICROCATHETER. THE DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441075 ↗
• MalfunctionSep 30, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06SEP2024. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE WAS BENT. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). HOWEVER, UPON UNPACKING, IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE WAS DETACHED AT DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20336321 ↗
• MalfunctionSep 18, 2024Entrapment of Device; Fracture; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED HEPATIC ARTERY. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS USED TRANSCATHETER HEPATIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, WHEN THE GUIDEWIRE ENTERED THE PATIENT. THE DEVICE WAS FOUND TO BE FRACTURED AND WAS STUCK IN THE CATHETER. THE DEVICE WAS PULLED OUT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249616 ↗
• MalfunctionAug 15, 2024Fracture; Difficult to Remove; Stretched; Difficult to Advance; Fracture; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY LIVER VESSEL. A 200CM X 10CM FATHOM GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDE WIRE REMAINED STATIONARY DURING ADVANCEMENT. HOWEVER, THERE WAS RESISTANCE UPON ATTEMPTING TO WITHDRAW IT, PROMPTING ITS COMPLETE REMOVAL. UPON EXAMINATION, THE GUIDE WIRE WAS FOUND TO BE STRETCHED (DEFORMED) AND FRACTURED AT THE DISTAL TIP. 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 19993856 ↗
• InjuryJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED, REQUIRING SNARE FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LIVER. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR TRANSHEPATIC ARTERIAL CHEMOEMBOLIZATION (TAC). HOWEVER, DURING THE PROCEDURE, IT WAS FOUND THAT PART OF THE GUIDEWIRE WAS FRACTURED INSIDE THE PATIENT. THE FRACTURED PART WAS REMOVED WITH A SNARE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618740 ↗
• MalfunctionMay 20, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2024. IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR TREATMENT AND ADVANCED. WHEN THE DEVICE WAS WITHDRAWN, IT FRACTURED INTO PIECES. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE IS NO FURTHER INFORMATION ABOUT WHETHER OR NOT FRAGMENTS WERE LEFT INSIDE THE PATIENT. NO COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THERE WERE KINK MARKS ON THE GUIDEWIRE BUT NOT FRACTURED, AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE WAS DETACHED, BENT, AND STRETCHED AT DISTAL TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355468 ↗
• MalfunctionApr 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PULMONARY ARTERY. A 200CM X 10CM FATHOM 14 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS FRACTURED AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174096 ↗
• MalfunctionApr 5, 2024Difficult to Remove; Detachment of Device or Device Component; Material Integrity Problem; Difficult to Remove; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED.A FATHOM -14 GUIDEWIRE WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, IT WAS FOUND THAT THE FATHOM WIRE TIP SPEERED OFF AND WOULD NOT PULL BACK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050431 ↗