DxTerity TRARecalls & reported problems across all models

We found 9 models of DxTerity TRA by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2017 and Feb 16, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DxTerity TRA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 16, 2018Terminated

   Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.

   Z-3253-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported DxTerity TRA problems

DxTerity TRA models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DxTerity™ TRA U5TRAN35

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 recall0 reports
• DxTerity™ TRA U5ULTRA40SH

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• DxTerity™ TRA U5TRAP35SH

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ TRA U5TRAP40SH

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ TRA U6TRAP40SH

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ TRA U5TRAN35SHA

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ TRA U5TRAN45SHA

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ TRA U5TRACTSHA

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ TRA U6ULTRA40SHA

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report

Recent DxTerity TRA adverse event reports

The 9 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Failure to Advance

  ELDERLY MALE WITH HISTORY OF ATRIAL FIBRILLATION, HYPERTENSION AND HEART FAILURE. WITH NEW ONSET CHEST PAIN, TO HEART CATH LAB FOR DIAGNOSTIC HEART CATH. WHEN PREPPING THE CATH, THE J-WIRE WOULD NOT GO THROUGH THE CATHETER. PRODUCT WAS NOT USED ON PATIENT, NEW DEVICE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331806 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT A DXTERITY DIAGNOSTIC CATHETER WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT A DAMPING EFFECT WAS OBSERVED AFTER THE CONTRAST INJECTION DESPITE BEEN IN THE AORTA.

  Patient problems: Injury

  MAUDE report 10281732 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DXTERITY DIAGNOSIS CATHETER WAS USED DURING A PROCEDURE TO TREAT A NON TORTUOSITY, NONE CALCIFIED LESION IN THE MID ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A DAMPING EFFECT WAS OBSERVED AFTER THE CONTRAST INJECTION DESPITE BEEN IN THE AORTA. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Injury; Occlusion

  MAUDE report 10256712 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A DXTERITY DIAGNOSTIC ANGIOGRAPHY CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 100% CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A DISSECTION OCCURRED DURING THE PROCEDURE. IT WAS INDICATED THAT THE CURVE OF THE DEVICE MAY HAVE CONTRIBUTED TO THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 8835192 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DXTERITY DIAGNOSTIC CATHETER WAS USED DURING A NORMAL HEART CATH PROCEDURE. NO DAMAGE WAS NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NO ALLEGED PRODUCT MALFUNCTION IS REPORTED. THE VESSEL ASSOCIATED WITH THE EVENT HAD MILD CALCIFICATION AND MILD TORTUOUSITY. AFTER THE PROCEDURE THE PATIENT BECAME LETHARGIC. MRI SHOWED SHOWED STROKE FROM RIGHT CAROTID SIDE WHICH IS THE SIDE THAT THE CATHETER WAS INTRODUCED. PATIENT FULLY RECOVERED.

  Patient problems: Stroke/CVA

  MAUDE report 7540197 ↗
• InjurySep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PHYSICIAN WAS USING A DEXTERITY DIAGNOSTIC CATHETER DURING A PROCEDURE. NO DAMAGE WAS NOTED TO THE CATHETER PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED AND PREPPED PER IFU. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE CATHETER WAS USED IN THE PROXIMAL RCA, WHICH EXHIBITED SEVERE TORTUOSITY AND WAS NOT CALCIFIED. DURING USE OF THE DEXTERITY A SPIRAL DISSECTION OF THE RCA OCCURRED. THERE WAS NO LESION IN THE LOCATION OF THE DISSECTION. THE PATIENT WAS SENT FOR BYPASS SURGERY AS THE PHYSICIAN WAS UNABLE TO GET WIRE THROUGH THE DISSECTION TO TREAT THIS AE. IT IS REPORTED THAT PATIENT IS DOING FINE POST PROCEDURE.

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem

  MAUDE report 6851351 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN WAS USING A DXTERITY DIAGNOSTIC CATHETER WHEN TREATING THE PROXIMAL LAD, MODERATE TORTUOSITY, NON-CALCIFIED, NO STENOSIS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT APPLIED. A DISSECTION OCCURRED NEAR THE LOCATION OF THE TIP OF THE CATHETER AND WAS TREATED WITH A RESOLUTE ONYX STENT. IT IS REPORTED THAT THE PHYSICIAN DOES NOT THINK THAT THE CATHETER CAUSED THE DISSECTION, BASED ON THE PATIENT'S CLINICAL SYMPTOMS, THIS DISSECTION MAY HAVE ALREADY BEEN THERE. NO OTHER DEVICE WAS IN THIS VESSEL. NO ADDITIONAL PATIENT CLINICAL SEQUELAE REPORTED.

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem

  MAUDE report 6851125 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED A DXTERITY GUIDE CATHETER WHEN TREATING THE RCA (OSTIUM/ PROXIMAL/ MID). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE CATHETER. THE CATHETER WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE CATHETER WAS PREPPED WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE GC, EXCESSIVE FORCE WAS NOT USED. THE RCA HAD NO CALCIFICATION, NO TORTUOSITY. WHEN THE PHYSICIAN WENT TO ENGAGE THE CATHETER, A SPIRAL DISSECTION OCCURRED IN THE OSTIUM TO MID VESSEL , CAUSED BY THE DIAGNOSTIC CATHETER WHEN IT ENGAGED THE SLIGHTLY ANTERIOR TAKE OFF OF THE RCA. THE DISSECTION WAS TREATED WITH TWO DRUG-ELUTING STENTS. NO SPECIFIC MALFUNCTION REPORTED BUT THE PHYSICIAN SAID THE STIFFNESS OF THE TIP OF THE DXTERITY IS MORE THAN LIKELY THE CAUSE. THERE IS NO ALLEGED PRODUCT ISSUE. NO ADDITIONAL PATIENT CLINICAL SEQUELAE REPORTED.

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem

  MAUDE report 6621801 ↗
• InjuryApr 21, 2017Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN INTENDED TO USE A DXTERITY DIAGNOSTIC CATHETER. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED. THE PHYSICIAN NOTICED OVALIZATION OF THE TIP PRIOR TO INSERTION IN PATIENT. THE INTENDED LESION WAS IN THE PROXIMAL RCA, NON-TORTUOUS, SEVERE CALCIFICATION AND (B)(6) STENOSIS. THE VESSEL HAD CALCIFIED ECCENTRIC PLAQUE. A DISSECTION OCCURRED DURING THE PROCEDURE. THE PHYSICIAN WAS NOT SURE IF THE DXTERITY CATHETER CAUSED THE DISSECTION, OR IF IT WAS JUST ECCENTRIC PLAQUE. THE VESSEL WAS IVUSED TO LOOK AT THE POSSIBLE DISSECTION BUT THE DETERMINATION WAS UNCLEAR. THE LESION WAS FFR AT (B)(6) NEGATIVE. WHEN THE POSSIBLE DISSECTION AFTER DIAGNOSTIC CATH WAS NOTED ON ANGIO REVIEW, AND WITH THE UNCERTAIN IVUS RESULT, THE DECISION WAS MADE TO STENT THE DISSECTION. NO ADDITIONAL PATIENT CLINICAL SEQUELAE REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 6511096 ↗

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