Platinum Plus™ M001466050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729114574), received between Sep 28, 2018 and Jun 9, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17MAY2023. IT WAS REPORTED THAT GUIDEWIRE UNRAVELED OCCURRED. THE PATIENT PRESENTED WITH HEART FAILURE. DURING AN INSERTION PROCEDURE OF A NON-BOSTON SCIENTIFIC DEVICE, FIVE 3 018/260 PLATINUM PLUS GUIDEWIRES WERE USED. HOWEVER, THE WIRES WERE UNRAVELED UPON INSERTION. VENOGRAM WAS PERFORMED TO MAKE SURE THAT THERE WAS NO STENOSIS THAT THE WIRES WERE GETTING STUCK IN. THE APPROXIMATE LOCATION OF THE DAMAGE ON THE DEVICE WAS THROUGH THE RIGHT INTERNAL JUGULAR. ALL THE GUIDEWIRES WERE REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED GUIDE WIRE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100984 ↗
• MalfunctionMar 21, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH HEART FAILURE. DURING AN INSERTION PROCEDURE OF A NON-BOSTON SCIENTIFIC DEVICE, FIVE 3 018/260 PLATINUM PLUS GUIDEWIRES WERE USED. HOWEVER, THE WIRES WERE UNRAVELED UPON INSERTION. VENOGRAM WAS PERFORMED TO MAKE SURE THAT THERE WAS NO STENOSIS THAT THE WIRES WERE GETTING STUCK IN. THE APPROXIMATE LOCATION OF THE DAMAGE ON THE DEVICE WAS THROUGH THE RIGHT INTERNAL JUGULAR. THE PHYSICIAN HAD TO REMOVE THE SHEATH AND WIRE TOGETHER AT ONE POINT JUST TO REMOVE A GUIDEWIRE. ALL THE GUIDEWIRES WERE REMOVED INTACT, AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587825 ↗
• InjuryJan 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WITH A SIGNIFICANT BEND OF LESS THAN 45 DEGREES WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED THORACIC DUCT. A 3 018/260 PLATINUM PLUS GUIDEWIRE WAS USED DURING PROCEDURE. HOWEVER, WHILE REMOVING THE GUIDEWIRE FROM THE PATIENT THROUGH THE 21-GAUGE NEEDLE, THE TIP OF THE GUIDEWIRE SHEARED OFF INTO THE PATIENT'S THORACIC DUCT. A SNARE WAS USED TO REMOVE THE DETACHED DEVICE, AND NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259462 ↗
• MalfunctionJan 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 018/260 PLATINUM PLUS GUIDEWIRE WAS USED FOR PERIPHERAL PROCEDURE. HOWEVER, WHEN THE DEVICE WAS PULLED, THE END OF THE WIRE BROKE OFF. THE DEVICE WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163864 ↗
• InjuryOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 3 018/260 PLATINUM PLUS GUIDEWIRE WAS USED IN A PROCEDURE. HOWEVER, WHEN PULLING BACK ON THE WIRE, THE RADIOPAQUE TIP CAME OFF. A SNARE WAS USED TO RETRIEVE THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685807 ↗
• MalfunctionSep 22, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND GUIDEWIRE DETACHMENT OCCURRED. THE PATIENT UNDERWENT CARDIOMEMS IMPLANT PROCEDURE. AFTER COMPLETING THE RIGHT HEART CATHETERIZATION, CONDUCTING AN ANGIOGRAM OF THE VESSELS ON THE LEFT SIDE AND FINDING A TARGET AREA, A 3 018/260 PLATINUM PLUS GUIDEWIRE WAS INSERTED. THE DELIVERY CATHETER WAS THEN ADVANCED OVER THE WIRE. HOWEVER, IT WAS DECIDED THAT THE DEVICES WERE TOO DISTAL FROM THE DESIRED LOCATION. THE DELIVERY CATHETER WAS PULLED BACK AND THE DEVICES APPEARED TO JUMP BACK UP TO THE ARCH. THE WIRE WAS ABLE TO BE MOVED BACK TO THE DESIRED POSITION WITHOUT DIFFICULTY. IT WAS NOTED THAT THE WIRE FELT A LITTLE "STICKY" INSIDE THE DELIVERY SYSTEM BUT SEEMED TO BE OKAY. THE SENSOR WAS THEN DEPLOYED IN THE TARGET AREA AND CALIBRATED WITH NO ISSUES. DURING WITHDRAWAL, IT WAS NOTED THAT THE GUIDEWIRE WAS SLOW TO BE REMOVED BUT WAS EVENTUALLY REMOVED. UPON VISUAL INSPECTION, THE GUIDEWIRE APPEARED TO HAVE BEEN PULLED APART. NO MATERIAL WAS THOUGHT TO HAVE BEEN LEFT IN THE PATIENT AND THE PHYSICIAN DID NOT BELIEVE THE DELIVERY CATHETER WAS AT FAULT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467866 ↗
• InjuryFeb 12, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND DEVICE TIP DETACHMENT OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE PEDAL ACCESS APPROACH. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A .018 HYDROPHILIC GUIDEWIRE WAS SELECTED TO NAVIGATE UP THE EXTREMELY CALCIFIED TIBIAL ARTERY.THE .018 HYDROPHILIC GUIDEWIRE WAS THEN EXCHANGED FOR THE PLATINUM PLUS-3 018/260 GUIDEWIRE TO ADVANCE FURTHER INTO THE PATIENT. A CROSSING SUPPORT CATHETER WAS USED DURING THE ADVANCEMENT OF THE PLATINUM PLUS-3 018/260 GUIDEWIRE AS IT WOULD ADVANCE BEYOND THE TIBIOPERONEAL TRUNK. AS THE PLATINUM PLUS-3 018/260 GUIDEWIRE WAS IN THE POPLITEAL ARTERY IT STARTED TO BACK OUT OF THE SUPPORT CATHETER. FORCE WAS APPLIED AND THE GUIDEWIRE WAS REMOVED FROM THE SUPPORT CATHETER AND FROM THE PATIENT. IT WAS THEN NOTICED THAT 1CM OF THE GUIDEWIRE TIP WAS DETACHED AND REMAINED IN THE VESSEL. ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED TIP; HOWEVER, RETRIEVAL WAS UNSUCCESSFUL. IT WAS DECIDED TO LEAVE THE REMAINING PIECE INSIDE THE SUBINTIMAL PLANE OF THE VESSEL. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH OTHER DEVICES AND SIMPLY BALLOONED THE LESION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11323155 ↗
• MalfunctionDec 11, 2018Detachment 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 GUIDEWIRE TIP BROKE AND REMAINED INSIDE THE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN THE TIBIAL VESSEL. A 018/260 PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP BROKE OFF IN THE PATIENT AND IT WAS UNABLE TO BE REMOVED FROM THE PATIENT'S ANATOMY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS NOT COMPLETED DUE TO UNKNOWN REASONS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8151425 ↗
• InjurySep 28, 2018Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 018/260 PLATINUM PLUS GUIDE CATHETER WAS ADVANCED. HOWEVER, IT WAS NOTED THAT THE WIRE BROKE OFF INSIDE THE PATIENT. THE REMAINING PIECE OF THE GUIDE WIRE WAS ABLE TO BE REMOVED WITHOUT PATIENT INJURY. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE IS CAUSE NOT ESTABLISHED SINCE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919179 ↗