PT Graphix™ H74914903011Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729254942), received between Dec 4, 2019 and Dec 4, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 Component1
- Difficult to Remove1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DIFFICULTY REMOVING A GUIDEWIRE AND GUIDEWIRE DETACHMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED CIRCUMFLEX (CX) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). DUE TO THE BIFURCATION TREATMENT (CX TO LAD), A 2.5 X 20MM PROMUS SELECT STENT WAS IMPLANTED IN THE LAD. FOR A KISSING BALLOON TREATMENT, A 182CM PT GRAPHIX GUIDEWIRE WAS INSERTED INTO THE LAD AND THE WIRE WAS PLACED UNDETECTED UNDER A STENT STRUT. AFTER THE KISSING BALLOON TREATMENT, THE PT GRAPHIX WIRE WAS REMOVED, BUT RESISTANCE WAS FELT. DURING REMOVAL, 3MM OF THE PT GRAPHIX WIRE TIP WAS TORN OFF AND FIXED UNDER THE STENT STRUT. NO INTERVENTION WAS PERFORMED TO REMOVE THE TIP FROM THE PATIENT AS IT WAS NOT POSSIBLE TO CROSS THE STENOSIS AND SO IT WAS NOT POSSIBLE TO REMOVE THE TIP FROM THE PATIENT. IT WAS NOTED THAT THE REASON FOR THE TIP DETACHMENT WAS DUE TO THE BIFURCATION STENOSIS. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9410528 ↗
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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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