PT²™ H7493893103J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729471202), received between Oct 3, 2018 and Sep 4, 2026 — classified as 1 death, 16 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Fracture

  It was reported that guidewire fracture occurred resulting in additional intervention.The target lesion was located in the left main coronary artery (LMCA). A 185cm PT2 guidewire was selected for use. However, during the procedure, it was observed that the guidewire fractured within the LMCA. An attempt was made to retrieve the fractured guidewire using a small-balloon capture technique; however, the retrieval attempt was unsuccessful. The physician decided to move the device fragment to a marginal branch. The procedure was completed without any patient complications. The patient was stable post-procedure.

  Patient problems: Foreign Body In Patient

  MAUDE report 50613298 ↗
• MalfunctionAug 12, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229907 ↗
• InjuryAug 18, 2025Fracture; Nonstandard Device; Fracture; Nonstandard Device

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE AND EMBOLISM OCCURRED. THE SEVERELY OCCLUDED TARGET LESION WAS LOCATED IN THE POSTERIOR DESCENDING BRANCH. A 185CM J-TIP, PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE WIRE BROKE AND EMBOLIZED INTO THE VESSEL. THE DEVICE WAS REMOVED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Embolism/Embolus

  MAUDE report 22834525 ↗
• MalfunctionMar 13, 2025Detachment 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 PATIENT, WHO HAD SEVERE CORONARY ARTERY DISEASE AND HAD ALREADY UNDERGONE 5 STENTS IMPLANTATION, CAME TO THE HOSPITAL TO TREAT 2 MORE LESIONS IN THE CIRCUMFLEX ARTERY. A 185CM J-TIP, 1-PACK PT2 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, 2 ADDITIONAL STENTS WERE SUCCESSFULLY IMPLANTED WITHOUT ANY ISSUES. HOWEVER, AT THE END OF THE PROCEDURE, WHEN REMOVING THE DEVICES, IT WAS DISCOVERED THAT THE TIP OF THE GUIDEWIRE HAD BROKEN OFF AND REMAINED IN A SMALL BRANCH OF THE CIRCUMFLEX ARTERY. THE PROCEDURE WAS COMPLETED WITHOUT AFFECTING THE BLOOD FLOW. THE PATIENT SHOWED NO SYMPTOMS AFTERWARD AND REMAINED STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21597365 ↗
• InjuryAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT AND DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE. FOLLOWING THE DEPLOYMENT OF 2.25X38 A NON-BOSTON SCIENTIFIC STENT, THE GUIDEWIRE WAS REMOVED, AND IT WAS NOTICED ON ANGIOGRAPHY THAT THE TIP OF THE WIRE SHEARED OFF AND REMAINED IN THE VESSEL AND COULD NOT BE RETRIEVED. THE PHYSICIAN THEN TRIED TO SNARE THE PIECE OF WIRE OUT, BUT A FLOW LIMITING DISSECTION OCCURRED. THE PATIENT WAS SENT FOR AN EMERGENCY CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. DURING CABG, THE PIECE OF WIRE STILL COULD NOT BE REMOVED. THE PATIENT WAS STABLE POST CABG AND EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 20069367 ↗
• InjuryMar 12, 2024Detachment 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 ANTERIOR DESCENDING ARTERY. A 185CM J-TIP, PT2 GUIDEWIRE WAS SELECTED FOR USE. A PT2 GUIDEWIRE WAS RECROSSED THROUGH THE STENT STRUTS, HOWEVER; WHEN THE GUIDEWIRE WAS REMOVED, THE TIP REMAINED INSIDE THE STENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT STATUS WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18890548 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE. THE WIRE WAS ATTEMPTED TO BE ADVANCED UP THE RADIAL ARTERY; HOWEVER, WHILE ADVANCING THE WIRE, THE TRANSITION OF THE FLOPPY TIP TO THE STIFFER PORTION OF THE WIRE WAS FRACTURED. THE DEVICE WAS RETRIEVED WITH A SNARE. A NEW PT2 GUIDEWIRE WAS THEN USED; HOWEVER, WHEN THE INSERTION WAS ATTEMPTED, THE NEW GUIDEWIRE TIP ALSO FRACTURED. A REPLACEMENT WIRE OF A DIFFERENT TYPE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FOLLOWING THE PROCEDURE, WHILE THE THIRD PT2 WIRE WAS EXAMINED IN THE CONTROL ROOM, THE TIP OF THE GUIDEWIRE WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711631 ↗
• InjuryFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE. THE WIRE WAS ATTEMPTED TO BE ADVANCED UP THE RADIAL ARTERY; HOWEVER, WHILE ADVANCING THE WIRE, THE TRANSITION OF THE FLOPPY TIP TO THE STIFFER PORTION OF THE WIRE WAS FRACTURED. THE DEVICE WAS RETRIEVED WITH A SNARE. A NEW PT2 GUIDEWIRE WAS THEN USED; HOWEVER, WHEN THE INSERTION WAS ATTEMPTED, THE NEW GUIDEWIRE TIP ALSO FRACTURED. A REPLACEMENT WIRE OF A DIFFERENT TYPE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FOLLOWING THE PROCEDURE, WHILE THE THIRD PT2 WIRE WAS EXAMINED IN THE CONTROL ROOM, THE TIP OF THE GUIDEWIRE WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711577 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USE. THE WIRE WAS ATTEMPTED TO BE ADVANCED UP THE RADIAL ARTERY; HOWEVER, WHILE ADVANCING THE WIRE, THE TRANSITION OF THE FLOPPY TIP TO THE STIFFER PORTION OF THE WIRE WAS FRACTURED. THE DEVICE WAS RETRIEVED WITH A SNARE. A NEW PT2 GUIDEWIRE WAS THEN USED; HOWEVER, WHEN THE INSERTION WAS ATTEMPTED, THE NEW GUIDEWIRE TIP ALSO FRACTURED. A REPLACEMENT WIRE OF A DIFFERENT TYPE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FOLLOWING THE PROCEDURE, WHILE THE THIRD PT2 WIRE WAS EXAMINED IN THE CONTROL ROOM, THE TIP OF THE GUIDEWIRE WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711576 ↗
• InjurySep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) IN OSTIUM RIGHT CORONARY ARTERY. A 185CM J-TIP PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, PART OF THE 0014 GUIDEWIRE BROKE DOWN AND WAS LEFT INSIDE THE CORONARY VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17684336 ↗
• MalfunctionMar 7, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A MODERATE SUPPORT 185CM J-TIP PT2 GUIDEWIRE MATERIAL WAS NOTED TO BE BENT AND BROKEN AT THE DISTAL END. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497276 ↗
• MalfunctionOct 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A 185CM J-TIP PT GUIDEWIRE WAS ADVANCED TO THE TARGET LESION. HOWEVER, DURING MANIPULATION OF THE GUIDEWIRE INSIDE THE VESSEL, THE TIP OF THE GUIDE WIRE BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION POST PROCEDURE WAS STABLE. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THE DISTAL TIP WAS DETACHED FROM THE BODY OF THE GUIDEWIRE AND NOT RETURNED. A KINK WAS ALSO NOTED 30 CM FROM THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619298 ↗
• InjuryJul 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 185CM PT GUIDE CATHETER WAS ADVANCED FOR TREATMENT. AFTER THE WIRE WAS PLACED IN THE DISTAL LAD, THE LESION WAS BALLOONED AND THEN STENTED. THE STENT BALLOON WAS REMOVED. HOWEVER, WHEN REMOVING THE WIRE FROM THE VESSEL, THE DOCTOR NOTICED THAT THE RADIOPAQUE END OF THE WIRE REMAINED IN THE VESSEL AND REQUIRED SNARING FOR REMOVAL. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058949 ↗
• MalfunctionJun 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A 185CM PT2 MODERATE SUPPORT WAS INSERTED IN THE TARGET LESION. HOWEVER, DURING THE PROCEDURE, WIRE FRAGMENTATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678140 ↗
• InjuryFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE DETACHED. A 185CM PT2 MODERATE SUPPORT GUIDEWIRE WAS SELECTED FOR PROCEDURE. DURING WITHDRAWAL, THE DISTAL TIP OF THE GUIDEWIRE DETACHED. APPROXIMATELY 1.5 CM DISTAL PART OF THE GUIDEWIRE REMAINED IN THE PATIENTS CORONARY ARTERY. THE WIRE HAS NOT BEEN IN A JAIL POSITION AND KINKING HAS BEEN SEEN ON THE CORONARY ARTERY. THE PROCEDURE COMPLETED WITH THIS PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13549508 ↗
• DeathOct 28, 2020Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT EXPERIENCED VENTRICULAR FIBRILLATION, VESSEL DISSECTION, BRADYCARDIA, CARDIAC ARREST AND DIED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A SUSPECTED CHRONIC TOTAL OCCLUSION WAS IN THE RIGHT CORONARY ARTERY. A 185CM J-TIP PT2 GUIDEWIRE WAS ADVANCED BUT FAILED TO CROSS THE RIGHT CORONARY DUE TO A PROBABLE CHRONIC OCCLUSION. THE GUIDE CATHETER WAS CHANGED TO A LEFT CORONARY CATHETER TO APPROACH THE CIRCUMFLEX AND THE PT2 WIRE WAS SUCCESSFULLY CROSSED. DURING REMOVAL OF THIS DEVICE, THE WIRE BROKE IN THE DISTAL CORONARY FOLLOWED BY DISSECTION IN THE ARTERY. THE WIRE WAS NOT ENTIRELY REMOVED. THE PATIENT PRESENTED WITH BRADYCARDIA AND WAS TREATED. VENTRICULAR FIBRILLATION OCCURRED AND WAS TREATED WITH CARDIOVERSION. VASOACTIVE DRUGS WERE STARTED. AFTER 15 TO 20 MINUTES, A BALLOON WAS INFLATED DISTALLY AND A PROXIMAL STENT WAS IMPLANTED. THE PATIENT SUBSEQUENTLY HAD CARDIAC ARREST AND DIED.

  Patient problems: Bradycardia; Cardiac Arrest; Death; Device Embedded In Tissue or Plaque; Foreign Body In Patient; Vascular Dissection; Ventricular Fibrillation

  MAUDE report 10748884 ↗
• InjuryAug 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED. A 185CM PT GUIDEWIRE WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE WIRE BECAME STUCK IN A STENT STRUT AND BROKE OFF. ADDITIONAL INTERVENTION WAS REQUIRED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT FULLY RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Code Available

  MAUDE report 10460328 ↗
• MalfunctionMar 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 185CM J-TIP PT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, UPON OPENING FOR USE, IT WAS OBSERVED THAT THE TIP HAD A CRACK OR BREAKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9865259 ↗
• InjuryJan 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND SURGICAL INTERVENTION WAS REQUIRED. THE TARGET LESION WAS LOCATED IN THE LEFT DIAGONAL ARTERY. A 185CM J-TIP GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, 2CM OF THE GUIDEWIRE TIP BROKE OFF INSIDE THE LEFT DIAGONAL ARTERY. THE PATIENT WAS SENT TO OPEN HEART SURGERY TO RETRIEVE THE BROKEN PIECE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9628169 ↗
• InjuryJan 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED DIAGONAL BRANCH OF THE CORONARY ARTERY. A 185CM J-TIP PT GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING WITHDRAWAL OF THE WIRE, THE TIP BROKE OFF AND THE DETACHED TIP WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9610478 ↗
• InjuryDec 11, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINED INSIDE THE PATIENT. THE TARGET LESION WAS IN THE CORONARY ARTERY. A MODERATE SUPPORT 185CM J-TIP PT2 GUIDEWIRE WAS USED FOR TREATMENT. DURING THE PROCEDURE, ENTRAPMENT OCCURRED WHEN REMOVING THE DEVICE. BLOOD FLOW WAS NOT COMPROMISED. THE GUIDEWIRE TIP FRACTURED AND LEFT INSIDE THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9452902 ↗
• InjuryDec 10, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DETACHMENT OF DEVICE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A PT2 GUIDEWIRE WAS USED FOR TREATMENT. HOWEVER, DURING PROCEDURE, ENTRAPMENT OCCURRED WHEN REMOVING THE DEVICE. THE GUIDEWIRE TIP FRACTURE REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9444376 ↗
• MalfunctionAug 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT GUIDE WIRE FRACTURE OCCURRED. A 185CM J-TIP, PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, WHEN PASSING THROUGH A NON-BSC INTRODUCER, IT WAS NOTED THAT THE GUIDE WIRE GOT FRACTURED AND WAS REMOVED THROUGH THE ACCESS IN THE LEFT FEMORAL ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871306 ↗
• MalfunctionJun 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 185CM J TIP PT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE WIRE WAS TORN AT ITS TIP WHILE COMING OUT OF THE COVER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8670660 ↗
• InjuryMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 185CM PT2 GUIDEWIRE WAS USED IN A PROCEDURE. HOWEVER, THE TIP OF THE WIRE BROKE OFF. THE DETACHED TIP WAS STENTED OVER TO SECURE IT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED VIA A MED WATCH REPORT THAT WHILE THE WIRE WAS IN THE VESSEL THAT IT FOLDED BACK ON ITSELF. POST STENTING, PHYSICIAN TRIED TO PULLED THE WIRE OUT BUT THE END OF THE WIRE BECAME LODGED IN THE STENT STRUT. THE PHYSICIAN TRIED TO USED MULTIPLE DEVICES TO GET THE WIRE BUT WAS NOT ABLE TO. THE WIRE WAS ABLE TO BE PULLED BACK PARTIALLY AND STRAIGHTENED OUT. BUT IN THE ATTEMPT TO GET IT UNSTUCK THE DISTAL END OF THE WIRE BROKE OFF. THE PATIENT WAS LEFT WITH A SMALL PORTION OF THE WIRE IN HER STENT STRUTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8650270 ↗