Platinum Plus™ M001466020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729035961), received between Oct 5, 2022 and Apr 16, 2024 — classified as 1 injury, 4 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2024Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS STRIPPED AND DEFORMED. THIS 0.018 IN X 260 CM PLATINUM PLUS GUIDEWIRE WAS REMOVED FROM ITS PACKAGING BUT WAS UNABLE TO BE USED. IT WAS NOTED THAT THE DEVICE WAS STRIPPED AND DEFORMED. A SECOND DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122187 ↗
• MalfunctionFeb 27, 2023Unraveled Material; Detachment of Device or Device Component; Difficult to Advance; Unraveled Material; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED. A 018/260 PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE IN A NON-BOSTON SCIENTIFIC CARDIOMEMS PROCEDURE. DURING THE PROCEDURE INSIDE THE PATIENT, IT WAS NOTICED THAT THE GUIDEWIRE COULD NOT BE ADVANCED, SO IT WAS WITHDRAWN. UPON REMOVAL, THE GUIDEWIRE WAS DISCOVERED TO BE UNRAVELED, FRAYED, AND SEPARATED AT THE TIP. THE PROCEDURE PROCEEDED WITH A V-18 GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449145 ↗
• InjuryDec 12, 2022Detachment 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 TIP DETACHED AND REMAINED IN THE PATIENT. A 018/260 PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE IN A CALCIFIED RECANALIZATION PROCEDURE, WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS SEVERELY CALCIFIED AND 90% STENOSED, WITH MODERATE TORTUOSITY. DURING THE PROCEDURE, USING A NON-BOSTON SCIENTIFIC SUPPORT CATHETER, THE TIP OF THE PLATINUM PLUS GUIDEWIRE HOOKED BEHIND A CALCIFIED PLAQUE AND BROKE OFF THE CORE OF THE WIRE. THE PIECE OF THE TIP WAS IMPACTED INTO THE VESSEL WALL, WITH A STENT AND NO FURTHER CONSEQUENCES OCCURRED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC SUPPORT CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15962158 ↗
• MalfunctionNov 23, 2022Entrapment of Device; Stretched; Unraveled Material; Difficult to Advance; Entrapment of Device; Stretched; Unraveled Material; Difficult to Advance

  IT WAS REPORTED THAT GUIDE WIRE ENTRAPMENT OCCURRED, WHICH PROLONGED THE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE INFERIOR BRANCH OF LEFT PULMONARY ARTERY (LPA). AFTER A 7FR GUIDE CATHETER WAS ENGAGED DURING A CARDIO MEMS PROCEDURE, A 018/260 PLATINUM PLUS GUIDEWIRE WAS INSERTED; HOWEVER, IT COULD NOT ADVANCE. THE COIL WIRE UNWOUND FROM THE CORE AND THE WIRE WOULD NOT TRAVERSE THE CATHETER IN THE RIGHT VENTRICULAR (TIP WAS IN THE LPA). THE WIRE CORE CAME BACK EASILY BUT THE PLATINUM CORE WAS STILL VISIBLE. THE WIRE NEVER EXITED THE NON-BOSTON SCIENTIFIC BALLOON TIPPED CATHETER AND ALL COMPONENTS WERE REMOVED FROM THE BODY. THE PLATINUM WIRE CAME OUT IN A VERY LONG STRAND AND THE TIP WAS FOUND TO BE UNRAVELED AND FRAYED. THE PROCEDURE WAS PROLONGED AND WAS COMPLETED WITH A V-18 GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854423 ↗
• MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED FEMORAL ARTERY. A 018/260 PLATINUM PLUS GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, WHEN IT WAS RETRIEVED FROM THE PATIENT, IT WAS NOTICED THAT THE FLOPPY DISTAL END WAS NOT ATTACHED TO THE GUIDEWIRE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546392 ↗