PT Graphix™ H7491490201J1Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of PT Graphix (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729254935), received between Jun 12, 2019 and Apr 12, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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
Device problems
- Detachment of Device or Device Component5
- Difficult to Advance1
Patient problems
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5115812 THAT DISTAL TIP DETACHMENT OCCURRED. A 182CM CHOICE PT GRAPHIX GUIDEWIRE WAS USED DURING A LEFT HEART CATHETERIZATION. HOWEVER, WHILE THE WIRE WAS BEING REMOVED, THE TIP OF THE WIRE SHEARED OFF. THE DEVICE FRAGMENT WAS RETAINED INSIDE THE VESSEL. SUBSEQUENTLY, CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) WAS PERFORMED FOR THREE TIMES. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 16724184 ↗InjuryFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND UNRETRIEVED DEVICE FRAGMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY STENOSIS. A 182CM PT GRAPHIX GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE GUIDEWIRE FRACTURED APPROXIMATELY BETWEEN BODY AND TIP. THE GUIDEWIRE TIP DEPRECATED FROM WIRE BODY. THE DETACHED PORTION WAS REMOVED; BUT A PORTION REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS THE PATIENT WAS SENT FOR TRANSTHORACIC SURGERY DUE TO COMPLICATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT WIRE TIP DISLODGED FROM WIRE BODY AND COULD NOT BE RETRIEVED PERCUTANEOUSLY. MOREOVER, THE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS DISCONTINUED IN LEU OF THE SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 16295077 ↗InjuryOct 12, 2021Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR DESCENDING ARTERY. A 182CM GRAPHIX GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, WHILE MANIPULATING THE GUIDEWIRE INSIDE THE VESSEL, RESISTANCE WAS ENCOUNTERED AND APPROXIMATELY 3CM OF THE GUIDEWIRE TIP WAS LEFT INSIDE THE ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DISLODGED GUIDEWIRE TIP BUT IT WAS NOT POSSIBLE TO WITHDRAW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT DETACHED TIP REMOVAL USING A SNARE WAS ATTEMPTED WITHOUT SUCCESS.
Patient problems: Foreign Body In Patient
MAUDE report 12620143 ↗InjuryDec 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED. A PT GRAPHIX GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE RADIOPAQUE TIP DETACHED INSIDE THE PATIENT. THE TIP COULD NOT BE REMOVED FROM THE PATIENT. THE TIP WAS MOVED TO A LOCATION WHICH WOULD NOT BE A DETRIMENT TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS WELL POST-PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9490090 ↗InjuryJun 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 182 J 5PK CHOICE PT GRAPHIX GUIDE WIRE WAS USED IN A PROCEDURE. HOWEVER, THE TIP OF THE WIRE BROKE OFF AND GOT STUCK IN A STENT INSIDE THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8691586 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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