PT²™ H74938931030Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729471189), received between Dec 9, 2015 and Nov 18, 2025 — classified as 2 deaths, 29 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MID-RIGHT CORONARY ARTERY. A 185 CM MODERATE SUPPORT STRAIGHT PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE DISTAL TIP OF THE WIRE HAD BROKEN OFF IN THE ARTERY. THE PHYSICIAN USED A SNARE AND WAS ABLE TO REMOVE THE DETACHED TIP OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584873 ↗
• InjuryNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 70% STENOSED TARGET LESION LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MIDDLE OF RIGHT CORONARY ARTERY. A 185CM PT GUIDEWIRE WAS SELECTED FOR USE AND SPUN BY THE PHYSICIAN UNTIL IT BECAME STUCK IN A CALCIFIC ARTERY. IT WAS THEN PULLED BACK, BUT THE TIP REMAINED IN THE ARTERY. SUBSEQUENTLY, A SNARE WAS USED TO COMPLETELY REMOVE THE FRACTURED PART OF THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575290 ↗
• InjurySep 4, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHED, AND EMBOLISM OCCURRED. THE PATIENT PRESENTED WITH CORONARY STENOSIS. THE 70% STENOSED LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). A PT2 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BECAME DISLODGED UPON RETRACTION, RESULTING IN AN EMBOLIC COMPLICATION. THE DETACHED TIP REMAINED IN THE OBTUSE MARGINAL (OM) BRANCH, AND NO RETRIEVAL WAS ATTEMPTED DUE TO THE VESSEL'S SMALL. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC GUIDEWIRE. THERE WERE NO FURTHER PATIENT COMPLICATIONS, THE PATIENT WAS SUCCESSFULLY TREATED FOR STENOSIS AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 22965389 ↗
• InjuryAug 27, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USED; HOWEVER, DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE OFF INTO A SMALL BRANCH OF A DISTAL CORONARY ARTERY. THE WIRE FRAGMENT WAS NOT ABLE TO BE RETRIEVED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22901455 ↗
• InjuryAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 185 CM PT2 GUIDEWIRE WAS SELECTED FOR USED; HOWEVER, DURING INTERVENTION IN THE FIRST OBTUSE MARGINAL VESSEL, THE GUIDEWIRE PROLAPSED INTO THE DISTAL VESSEL. MULTIPLE BALLOONS WERE USED FOR PCI WITH MULTIPLE INFLATIONS. WHEN THE WIRE WAS REMOVED, APPROXIMATELY 15 MM OF THE WIRE WAS BROKEN OFF. AFTER 30 MINUTES OF UNSUCCESSFUL RETRIEVAL ATTEMPTS, THE PHYSICIAN DECIDED TO LEAVE THE DETACHED COMPONENT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22707524 ↗
• InjuryNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 185 CM STR PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PERCUTANEOUS CORONARY INTERVENTION, THE WIRE TIP CAME OFF IN THE VESSEL. THE DEVICE WAS PARTIALLY EXPLANTED, AND A PORTION REMAINS IMPLANTED. THE PROCEDURE WAS COMPLETED, AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20625035 ↗
• InjuryMar 7, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE WIRE SHEARED OFF AND THE TIP DETACHED WHICH REMAINED IN THE BODY. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID PROXIMAL SEPTAL OF THE LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, A 185CM PT2 GUIDEWIRE SHEARED OFF AND THE TIP DETACHED. THE WIRE WAS PULLED, AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE GUIDEWIRE TIP. THE USER WAS NOT ABLE TO ACCESS THE DEVICE TIP; IT WAS NOTED THAT THERE WAS A STENT IN THE WAY, AND THE TIP OF THE DEVICE WAS LEFT IN THE SMALL SEPTAL. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18862862 ↗
• InjuryNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED. A 185CM PT2 WIRE WAS SELECTED FOR USE TO TREAT THE 100% STENOSED TARGET LESION LOCATED IN THE NON-TORTUOUS AND CALCIFIED VESSEL. HOWEVER, THE WIRE WAS JAILED BETWEEN TWO SYNERGY XD DRUG-ELUTING STENTS. CONSEQUENTLY, THE TIP OF THE WIRE BROKE INTO TWO PIECES AND THE FRAGMENTS REMAINED INSIDE THE PATIENT'S BODY. THERE WAS NO DAMAGE OR ISSUE OBSERVED WITH THE TWO SYNERGY XD STENTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18083596 ↗
• DeathOct 30, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT AND PATIENT DEATH OCCURRED. THE PATIENT DECLINED SURGERY AND OPTED FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR MULTI VESSEL DISEASE TREATMENT. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED LEFT MAIN (LM). TWO NON-BOSTON SCIENTIFIC STENTS WERE DEPLOYED, ONE IN THE RIGHT CORONARY ARTERY AND ANOTHER IN THE LM. HOWEVER, UPON REMOVAL OF THE PT2 WIRE THROUGH THE STENT IN THE LM, RESISTANCE WAS FELT, AND THE TIP OF THE WIRE BROKE. THE TIP WAS NOT RETRIEVED, AND ANGIOGRAM SHOWED IT WAS IN THE DISTAL OBTUSE MARGINAL. NO ADDITIONAL INTERVENTION WAS PERFORMED AFTER THE TIP OF THE WIRE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE POST PROCEDURE BUT DIED LATER ON THE SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18030877 ↗
• InjuryDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 185CM MODERATE SUPPORT STRAIGHT TIP PT2 GUIDEWIRE WAS SELECTED FOR USE IN THE STENTING PROCEDURE TO A LESION IN THE RIGHT CORONARY ARTERY. THE TIP OF THE PT2 GUIDEWIRE DETACHED. THE DETACHED TIP REMAINED IN THE VESSEL. THE PROCEDURE WAS CANCELLED. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15965697 ↗
• InjuryNov 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 185CM MODERATE SUPPORT STRAIGHT TIP PT2 GUIDEWIRE WAS SELECTED FOR USE. POST STENT IMPLANT THE PT2 GUIDEWIRE TIP DETACHED DURING RETRIEVAL. THE DETACHED TIP WAS STENTED TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828769 ↗
• InjuryMay 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINS IN THE PATIENT. A 185CM MODERATE SUPPORT STRAIGHT PT2 GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, AT THE END OF THE ANGIOGRAM, IT WAS NOTICED THAT THERE WAS A RADIOPAQUE PORTION SHOWING ON THE CINEANGIOGRAPHY. WHEN THE PT2 WIRE WAS CHECKED, IT WAS NOTICED THAT THE DISTAL END OF THE WIRE HAD FRACTURED OFF. A SURGICAL CONSULTANT WAS THEN CALLED TO EVALUATE, AND IT WAS DECIDED TO LEAVE THE FRAGMENT IN ONE OF THE DIAGONALS OF A VESSEL AS IT WAS NOT CAUSING ANY ISSUES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS MONITORED EXTENSIVELY POST PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14437738 ↗
• InjuryJan 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT TIP DETACHMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 185CM PT GUIDEWIRE WAS ADVANCED INTO THE LESION. HOWEVER, DURING THE PROCEDURE, THE WIRE TIP BROKE OFF AT A DISTAL SIDE BRANCH OF THE ARTERY. THE TIP DID NOT CAUSE CHEST PAIN AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. NO EVIDENCE OF PERFORATION OF THE DISTAL VESSEL WAS NOTED. THE TIP WAS LEFT IN PLACE AS THE CLINICIAN FELT THAT THE RISK TO RETRIEVE THE OBJECT OUTWEIGHED THE RISK OF LEAVING IT IN. A 3.0 X 22MM DRUG-ELUTING STENT WAS SUCCESSFULLY PLACED WITH A REDUCTION OF STENOSIS IN THE ARTERY TO 0% AND RETURN OF BLOOD FLOW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13343862 ↗
• InjurySep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP FRACTURE OCCURRED. A 185CM STR, PT GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, THE PHYSICIAN FOUND THAT THE TIP OF THE GUIDE WIRE WAS FRACTURED. THE DEVICE WAS REMOVED WITH A SNARE AND NO DEBRIS WAS LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 70% STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12417222 ↗
• InjuryJun 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED KNEE VASCULAR. A 185CM PT2 GUIDEWIRE WAS USED FOR DELIVERY. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS COMPLETELY DETACHED 5 CENTIMETERS FROM THE TIP. THE DEVICE WAS REMOVED BY SNARING. 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 12045735 ↗
• InjuryMay 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 185CM PT2 GUIDEWIRE FAILED TO CROSS THE LESION, AND WHEN REMOVED, THE GUIDEWIRE WAS FOUND TO BE FRACTURED. THE PHYSICIAN CUT AND REMOVED THE GUIDEWIRE, HOWEVER, A FRACTURED PORTION REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AFTER BEING DISCHARGED FROM HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 11771255 ↗
• InjurySep 21, 2020Detachment 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 TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 185CM PT2 GUIDE WIRE WAS USED IN A PROCEDURE. HOWEVER, IT WAS NOTICED THAT TIP WAS FRACTURED WHEN THE PHYSICIAN ADJUSTED THE GUIDE WIRE. THE FRACTURED PART WAS LEFT INSIDE PATIENT'S BODY AND THE PHYSICIAN RESCHEDULED THE PROCEDURE TO RETRIEVE THE FRAGMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THE LESION WAS SEVERELY STENOSED WITH MILD CALCIFICATION AND MILD TORTUOSITY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10560637 ↗
• MalfunctionSep 8, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDE WIRE COATING ISSUE OCCURRED. A 185CM STR PT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE COATING WAS PEELED OFF, AND THE 2.00MM X 8MM EMERGE BALLOON CATHETER LUMEN WAS CLOGGED UP IN THAT COATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10504657 ↗
• MalfunctionJun 26, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING PEELED OFF. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING ADVANCING, THE PHYSICIAN FELT THAT THE WIRE WAS DIFFERENT THAN USUAL. AFTER PROCEDURE, IT WAS NOTED THAT THE COATING OR THE WIRE WAS SLIGHTLY PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200143 ↗
• MalfunctionMar 16, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDE WIRE COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 185CM MODERATE SUPPORT STRAIGHT PT GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS OBSERVED THAT THE OUTER COATING GOT SEPARATED FROM THE WIRE AND FORMED A CLUMP. THE DEVICE WAS REMOVED AND NO DEVICE FRAGMENT REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835068 ↗
• InjuryFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE. THE PHYSICIAN WAS ABLE TO PLACE THE BALLOON AND STENT HOWEVER, DURING REMOVAL, APPROXIMATELY 8-10MM SEGMENT OF THE DISTAL TIP OF THE WIRE REMAINED IN THE PATIENT'S CORONARY ARTERY. THE END OF THE WIRE WAS RETAINED IN THE PATIENT'S BODY AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9738983 ↗
• MalfunctionNov 15, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS NOT SEALED. A 185CM PT GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, WHEN THE PACKAGING WAS TAKEN OUT FROM THE SHELF, THE WIRE FELL OUT FROM THE PACKAGE AND IT WAS OBSERVED THAT THE LOWER PART OF THE PACKAGING WAS NOT SEALED. NO FURTHER DAMAGE WAS NOTED WITH THE PACKAGING AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9327859 ↗
• InjuryOct 25, 2019Detachment 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 A GUIDEWIRE BREAK OCCURRED. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE IN A CARDIAC PROCEDURE. HOWEVER, THE WIRE BROKE INSIDE THE PATIENT'S BODY. NO ATTEMPT WAS MADE TO REMOVE THE BROKEN PORTION. IT WAS NOTED THAT THE BROKEN GUIDEWIRE DID NOT TRAVEL OR MOVE THROUGH THE ARTERY AFTER THE BRAKE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9239566 ↗
• InjuryOct 15, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 185CM MODERATE SUPPORT STRAIGHT PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE WIRE WAS FRACTURED. IT WAS NOTED THAT THE LOCATION OF THE FRACTURE WAS NOT WHERE THE TIP WAS SHAPED. THE FRACTURED TIP MIGRATED TO SMALL DISTAL BRANCH. PHYSICIAN DID NOT ATTEMPT TO SNARE THE DETACHED WIRE AS IT WAS SAFER FOR THE PATIENT TO LEAVE THE TIP. THE PROCEDURE WAS COMPLETED AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9195191 ↗
• InjuryOct 9, 2019Fracture; Fracture

  IT WAS REPORTED THAT A GUIDEWIRE TIP FRACTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 185CM MODERATE SUPPORT STRAIGHT PT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, AT THE END OF THE PROCEDURE, THE TIP OF THE GUIDEWIRE FRACTURED OFF INSIDE THE PATIENT. THE FRACTURED TIP WAS SUCCESSFULLY SNARED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171708 ↗