PT Graphix™ H7491490301J1Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729254959), received between Mar 13, 2020 and Mar 14, 2025 — classified as 2 injuries, 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Fracture1
- Positioning Problem1
Patient problems
- Device Embedded In Tissue or Plaque2
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 182CM J PT GRAPHIX GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, WHILE CROSSING THE LESION, A PIECE OF THE GUIDEWIRE BROKE OFF IN THE VESSEL. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606924 ↗MalfunctionJun 12, 2020Positioning Problem
THE PATIENT WAS UNDERGOING A PLACEMENT OF THREE CORONARY STENT IN HIS RIGHT CORONARY ARTERY. WHILE REMOVING HIS CORONARY WIRE AFTER STENT PLACEMENT, IT WAS NOTED THE EMBOLIZATION OF THE NITINOL WIRE TIP COVERING IN THE RIGHT CORONARY ARTERY, ADJACENT TO THE STENT. FLUOROSCOPY CONFIRMED THE NITINOL COVERING OF THE TIP OF THE WIRE WAS IN THE RCA. A DECISION WAS MADE TO REWIRE WITH A DIFFERENT WIRE, STENTING THE AREA AND SECURING THE TIP TO THE VESSEL WALL.
Patient problems: Failure of Implant
MAUDE report 10147908 ↗InjuryJun 9, 2020Detachment 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 RIGHT CORONARY ARTERY (RCA). A 182CM J CHOICE PT GRAPHIX STANDARD GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE TIP OF THE GUIDEWIRE WAS FRACTURED. THE DETACHED TIP COULD NOT BE RETRIEVED WITH A SNARE. AN UNKNOWN DRUG-ELUTING STENT WAS USED TO AFFIX AND APPOSE THE DETACHED TIP IN PLACE IN THE RCA. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10133993 ↗InjuryMar 13, 2020Detachment 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 LEFT ANTERIOR DESCENDING ARTERY. A 182CM J PT GRAPHIX GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE WIRE PROLAPSED ON ITSELF. THEN THE TIP OF THE WIRE BECAME DISCONNECTED AND BROKE OFF INSIDE THE ARTERY. SNARING WAS ATTEMPTED BUT FAILED TO RETRIEVE THE DETACHED TIP. ANOTHER WIRE WAS USED AND COMPLETED THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS FINE AND STABLE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9829902 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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