FATHOM™ -14 M001508100Recalls & reported problems
Boston Scientific Corporation · Steerable Guidewire · Class 2
Quick summary
This Boston Scientific Fathom-14 steerable guidewire is used to navigate blood vessels during procedures like embolization. The 42 reports mostly describe the wire fracturing or its tip detaching, in some cases leaving a fragment inside the patient. There were no deaths and 12 injuries. No recalls name this device. Reports have declined recently, with 3 in the last 12 months compared with 9 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729801023), received between May 1, 2019 and Sep 23, 2026 — classified as 12 injuries, 31 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component20
- Fracture11
- Adverse Event Without Identified Device or Use Problem9
- Material Integrity Problem9
- Material Deformation4
- Stretched3
- Difficult to Advance2
- Entrapment of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Foreign Body In Patient6
- Device Embedded In Tissue or Plaque2
- No Consequences Or Impact To Patient2
- Hemorrhage/Blood Loss/Bleeding1
- No Patient Involvement1
- Perforation of Vessels1
- Vasoconstriction1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Entrapment of Device; Detachment of Device or Device Component
It was reported that the guidewire fractured inside the microcatheter during insertion.A 200 cm X 10 cm FATHOM? -14 guidewire was selected for use in a Y-90 mapping procedure. The guidewire had been shaped five to six times prior to use. While inserting the guidewire into a 2.4F non-Boston Scientific (BSC) microcatheter, the guidewire felt crunchy. An attempt was made to take the guidewire out of the microcatheter, but the guidewire became stuck within the microcatheter and broke apart. The guidewire fractured into two pieces; both pieces were removed. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868761 ↗MalfunctionAug 14, 2026Stretched; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260544 ↗MalfunctionJan 12, 2026Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT TRACKING DIFFICULTY OCCURRED. DURING A GENICULAR ARTERY EMBOLIZATION, A 14, 200 CM X 10 CM FATHOM GUIDEWIRE WAS SELECTED FOR USE. IT WAS ATTEMPTED TO ADVANCE THE MICROWIRE THROUGH THE 155CM TRUSELECT MICROCATHETER, BUT INCREASED RESISTANCE WAS NOTICED. THE MICROCATHETER WAS REMOVED, RE-FLUSHED, AND THE MICROWIRE WAS ADVANCED AGAIN, BUT THE SAME RESISTANCE WAS ENCOUNTERED. IT WAS ATTEMPTED TO REMOVE THE MICROWIRE AGAIN, BUT BOTH MICROCATHETER AND MICROWIRE STARTED TO BUNCH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE COATING WAS PEELED,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24048084 ↗InjuryNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A GUIDEWIRE FRACTURE AND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS ON MEDICATION. DURING A PROCEDURE USING A NON-BOSTON SCIENTIFIC REVERSED CURVED CATHETER IN VERY TORTUOUS ANATOMY, THE PHYSICIAN PERFORMED TWO 180-DEGREE TURNS TO ADVANCE THE DEVICE. A 200 CM X 10 CM FATHOM-14 GUIDEWIRE WAS INTRODUCED AND MANIPULATED WITHIN THE CATHETER. DURING THIS PROCESS, APPROXIMATELY 6 CM OF THE GUIDEWIRE SNAPPED OFF FROM THE BACK END WHILE INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED RETRIEVAL BY ADVANCING AND RETRACTING THE MICROCATHETER, AS WELL AS PULLING BACK AND ASPIRATING, BUT THE FRAGMENT REMAINED LODGED. IT WAS BELIEVED THAT VASOSPASM OCCURRED, PREVENTING FURTHER MOVEMENT. THE SEPARATED PORTION WAS THOUGHT TO HAVE BECOME LODGED IN A PELVIC SIDEWALL BRANCH NEAR THE UPPER GASTRIC REGION. THE VESSEL WAS NOTED TO HAVE SPASM BUT WAS NOT SIGNIFICANTLY CALCIFIED. THE PHYSICIAN DID NOT ANTICIPATE ANY ADVERSE EFFECTS FROM THE RETAINED FRAGMENT. THE PROCEDURE WAS COMPLETED, AND THE PATIENT, WHO WAS ON ANTICOAGULATION THERAPY, IS EXPECTED TO FULLY RECOVER.
Patient problems: Foreign Body In Patient; Vasoconstriction
MAUDE report 23542286 ↗MalfunctionJul 25, 2025Fracture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED. A 200 CM X 10 CM FATHOM? -14 GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, THERE WAS NO RESISTANCE, BUT THE GUIDEWIRE SHEARED OR FRACTURED. IT APPEARS THAT THE GUIDEWIRE MAY HAVE BEEN DAMAGED PRIOR TO BEING FULLY REMOVED FROM ITS PLASTIC CASING. PEELED COATING WAS NOTICED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22613836 ↗InjuryJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 14, 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS USED FOR TREATMENT DURING A DIFFICULT Y90 ADMINISTRATION. DURING THE PROCEDURE, AFTER APPROXIMATELY AN HOUR, 8 MM OF THE GUIDEWIRE TIP BROKE OFF AND MIGRATED TO A DISTAL BRANCH OF THE SPLENIC ARTERY. AN ATTEMPT WAS MADE TO RETRIEVE THE BROKEN FRAGMENT USING A MICROSNARE. THE TIP OF THE GUIDEWIRE WAS NOT RETRIEVED, LEAVING IT AS A FOREIGN BODY WITHIN THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING A NEW FATHOM GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT FULLY RECOVERED.
Patient problems: Foreign Body In Patient
MAUDE report 22543346 ↗InjuryJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP BROKE OFF. THE STENOSED TARGET LESION WAS LOCATED IN THE RETROPERITONEAL THORACIC DUCT. A 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE SEPARATED AND WAS RETAINED WITHIN THE PATIENT. IT WAS SECURED IN PLACE WITHIN THE VESSEL, AS THE PHYSICIAN'S INITIAL PLAN INVOLVED EMBOLIZATION OF THE VESSEL WITH COILS. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 22515972 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEVICE BROKE. THE TARGET LESION WAS LOCATED IN THE LIVER. A 200 CM X 10 CM FATHOM? -14 WAS SELECTED FOR USE. HOWEVER, DURING VESSEL TRACKING, IT WAS NOTED THAT THE GUIDEWIRE HAD BROKEN. THE DEVICE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009752 ↗MalfunctionApr 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE WIRE BROKE OFF. A 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS ADVANCED FOR PROSTATIC ARTERY EMBOLIZATION PROCEDURE. HOWEVER, THE TIP OF THE WIRE BROKE OFF AND THE DETACHED PORTION WAS LEFT INSIDE THE PATIENT, WHILE THE OTHER PORTION WAS REMOVED. THE CASE WAS COMPLETED AFTERWARDS, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 21831178 ↗MalfunctionNov 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE IN A PROSTATE ARTERY EMBOLIZATION. DURING REMOVAL FROM THE CATHETER, THE WIRE SNAPPED. THE SHEATH, BASE CATHETER, AND MICROCATHETER HAD TO BE REMOVED IN ORDER TO RETRIEVE PIECES OF WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20777762 ↗MalfunctionNov 6, 2024Material 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 THE WIRE COATING BROKE OFF. A 200 CM X 10 CM FATHOM -14 WAS SELECTED FOR USE IN A PROSTATIC ARTERY EMBOLIZATION (PAE) PROCEDURE. DURING INSERTION INTO THE NON-BOSTON SCIENTIFIC MICROCATHETER, IT WAS NOTED THAT COATING OF THE WIRE BROKE OFF/DETACHED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620299 ↗MalfunctionNov 6, 2024Material 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 THE WIRE COATING BROKE OFF. A 200 CM X 10 CM FATHOM -14 WAS SELECTED FOR USE IN A PROSTATIC ARTERY EMBOLIZATION (PAE) PROCEDURE. DURING INSERTION INTO THE NON-BOSTON SCIENTIFIC MICROCATHETER, IT WAS NOTED THAT COATING OF THE WIRE BROKE OFF/DETACHED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620240 ↗MalfunctionNov 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE WIRE BROKE INSIDE THE CATHETER. A 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE BROKE INSIDE THE CATHETER AND NOT IN THE VESSEL. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20599753 ↗MalfunctionOct 1, 2024Stretched; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Stretched; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE GUIDEWIRE WAS STRETCHED AND DETACHED. A 200 CM X 10 CM FATHOM-14 WAS SELECTED FOR A PROCEDURE. DURING USE, HOWEVER, THE WIRE STRETCHED AND SEEMED TO FALL APART WHILE ATTEMPTING TO DIRECT IT INSIDE THE PATIENT. THE WIRE WAS ABLE TO BE REMOVED, AND AN ALTERNATE METHOD WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20345125 ↗InjurySep 27, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED, REQUIRING SNARE FOR REMOVAL. A 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE IN THE TREATMENT OF VASCULAR STENOSIS IN THE SUBCLAVIAN ARTERY. HOWEVER, THE GUIDEWIRE WAS FRACTURED UPON WITHDRAWAL AND SNARING WAS PERFORMED TO REMOVE THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20326477 ↗InjuryJun 25, 2024Fracture; Fracture
IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY PROCEDURE. A 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE. THE PATIENT WAS SEDATED WITH LOCAL ANESTHESIA. DURING THE PROCEDURE, A BALLOON WAS DELIVERED ALONG WITH THE GUIDEWIRE TO THE LESION. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE SUDDENLY FRACTURED PARTIALLY. THE FRACTURE GUIDEWIRE WAS COMPLETELY REMOVED FROM THE PATIENT BY A THROMBECTOMY STENT, AND THE PROCEDURE WAS ENDED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT FRACTURED PART OF THE GUIDE WIRE WAS SEPARATED FROM THE REST OF THE GUIDEWIRE AND THE TIP IS INSIDE THE BLOOD VESSEL, AND THE SNARE CANNOT HOOK THE GUIDEWIRE TIP, AND THE PROCEDURE WAS CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19604443 ↗MalfunctionJun 24, 2024Stretched; Material Deformation; Stretched; Material Deformation
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28MAY2024. IT WAS REPORTED THAT THE GUIDEWIRE TIP WAS KINKED AND STRETCHED. THE PATIENT UNDERWENT MESENTERIC ANGIOGRAM FOR POSSIBLE BLEEDING. A 200 CM X 10 CM FATHOM 14 GUIDEWIRE WAS USED TOGETHER WITH A NON-BOSTON SCIENTIFIC (BSC) MICROCATHETER DURING THE PROCEDURE. HOWEVER, ANGIOGRAPHY REVEALED THAT THE TIP LOOKED KINKED, AND AFTER REMOVAL, THE TIP LOOKED STRETCHED. THE GUIDEWIRE WAS REMOVED FULLY INTACT THROUGH THE MICROCATHETER, AND ANOTHER 200 CM X 10 CM FATHOM -14 GUIDEWIRE WAS USED. HOWEVER, THE TIP OF THE GUIDEWIRE WAS ALSO KINKED AND STRETCHED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE WIRES. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19594926 ↗MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 200 CM X 10 CM FATHOM -14 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP BROKE OFF AFTER SHAPING. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19230419 ↗MalfunctionNov 20, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT AN ACCUMULATION OF COATING AT THE TIP OCCURRED. A 200CMX10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE WIRE WAS PULLED FROM THE HOOP, THERE WAS ALMOST WHAT FELT LIKE A SMALL BALL ACCUMULATING ON THE VERY DISTAL TIP OF THE WIRE. THE WIRE WAS IMMEDIATELY REMOVED FROM THE TABLE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18174844 ↗InjuryNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED AND IT WAS REMOVED WITH A SNARE. A 200 CM X 10 CM FATHOM-14 WAS SELECTED FOR USE TO PERFORM A PRE-Y90 MAPPING. DURING THE PROCEDURE, THE FATHOM WIRE BROKE OFF AND REMAINED IN THE PATIENT'S BODY. THE BROKEN PART OF THE WIRE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITH A SNARE AND THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT IS STABLE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156273 ↗InjuryJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH MW5118134 THAT THE WIRE TIP DETACHED. A 200 CM X 10 CM FATHOM-14 WAS SELECTED FOR USE TO EMBOLIZE AN ACUTE BLEEDING. DURING THE PROCEDURE, THE END OF FATHOM WIRE BROKE OFF AND REMAINED IN THE PATIENT'S BODY. THE PHYSICIAN FELT THAT IT WOULD BE MORE DANGEROUS TO ATTEMPT TO RETRIEVE THE FOREIGN OBJECT AS THE PATIENT IS DNR (DO NOT RESUSCITATE) CONDITION.
Patient problems: Foreign Body In Patient
MAUDE report 17260634 ↗MalfunctionJun 30, 2023Unraveled Material; Unraveled Material
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2023. IT WAS REPORTED THAT THE SPRING TIP UNRAVELED. A FATHOM -14 WAS SELECTED FOR USE. THE PATIENT WAS BEING TREATED DUE TO BLEEDING IN THE LUMBAR ARTERY. THERE WAS MILD TORTUOSITY. THE GUIDEWIRE WAS USED TO BRING A PUSHABLE COIL OUT OF THE CATHETER. WHILE WITHDRAWING THE GUIDEWIRE, THE SPRING TIP UNRAVELED. THE PROCEDURE WAS COMPLETED WITH THIS GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE DISTAL TIP HAD DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17241180 ↗InjuryJun 7, 2023Fracture; Fracture
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. TWO 200 CMX10 CM FATHOM-14 GUIDEWIRE WERE SELECTED FOR USE. DURING ADVANCING, IT WAS NOTED THAT DEVICE FRACTURE OCCURRED APPROXIMATELY 6 INCHES FROM THE TOP OF THE WIRE. THIS DEVICE WAS SNARED AND SINCE THE SECOND DEVICE WAS STILL CONNECTED, IT WAS EASILY REMOVED. AS PER PHYSICIAN'S OPINION, THE FRACTURE WAS POSSIBLY CAUSED BY THE TORTUOSITY OF THE VESSEL AND GOING THROUGH STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17079646 ↗MalfunctionJun 7, 2023Fracture; Fracture
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. TWO 200 CMX10 CM FATHOM-14 GUIDEWIRE WERE SELECTED FOR USE. DURING ADVANCING, IT WAS NOTED THAT DEVICE FRACTURE OCCURRED APPROXIMATELY 6 INCHES FROM THE TOP OF THE WIRE. THE FIRST DEVICE WAS SNARED AND SINCE THIS DEVICE WAS STILL CONNECTED, IT WAS EASILY REMOVED. AS PER PHYSICIAN'S OPINION, THE FRACTURE WAS POSSIBLY CAUSED BY THE TORTUOSITY OF THE VESSEL AND GOING THROUGH STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17079630 ↗InjuryJun 2, 2023Break; Entrapment of Device
DURING EMERGENT PROCEDURE TO EMBOLIZE AN ACUTE BLEED, END OF FATHOM WIRE BROKE OFF AND REMAINS IN THE BODY. PATIENT WAS DNR(DO NOT RESUSCITATE), IT WAS FELT TO BE MORE DANGEROUS TO ATTEMPT TO RETRIEVE THE FOREIGN OBJECT VERSUS LEAVING IT IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; Hemorrhage/Blood Loss/Bleeding
MAUDE report 17059097 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.