Verrata Plus Pressure Guide WireRecalls & reported problems across all models

We found 2 models of Verrata Plus Pressure Guide Wire by Philips Image Guided Therapy Corporation in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2017 and Sep 26, 2024 — classified as 1 death, 20 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 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. 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

Most reported Verrata Plus Pressure Guide Wire problems

Verrata Plus Pressure Guide Wire models

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

• Verrata Plus Pressure Guide Wire 10185P

  Wire, Guide, Catheter
  1 death41 reports
• Verrata Plus Pressure Guide Wire 10185JP

  Transducer, Pressure, Catheter Tip
  4 reports

Recent Verrata Plus Pressure Guide Wire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A VERRATA PRESSURE GUIDEWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. DURING USE, MEASUREMENT DRIFT WAS EXPERIENCED OUTSIDE THE ACCEPTABLE PARAMETERS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MEASUREMENT DRIFT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314743 ↗
• MalfunctionNov 17, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A VERRATA 10185P WIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE WITH A PRIOR CORONARY STENT. AFTER COMPLETING THE IFR MEASUREMENT, THE PHYSICIAN NOTICED SMALL PAINT SCRAPS OF COATING WERE ON HER SURGICAL GLOVE. NO PORTION OF THE DEVICE SEPARATED INSIDE THE PATIENT. THE PATIENT WAS FINE WITH NO INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VERRATA COATING MATERIAL PEELED OFF. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18164020 ↗
• InjuryApr 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A VERRATA 10185P WIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE IN THE LAD ARTERY. DURING USE, THE WIRE WAS UNABLE TO CROSS THE LESION. WHILE ATTEMPTING TO REMOVE FROM THE PATIENT, THE DISTAL END GOT LODGED INTO THE CALCIUM, THE WIRE UNCOILED AND SEPARATED IN TWO PIECES. THE PROXIMAL PORTION OF THE WIRE WAS REMOVED, LEAVING THE DISTAL PORTION IN THE PATIENT. SEVERAL SNARE DEVICES WITH DIFFERENT SIZES WERE USED TO RETRIEVE, BUT UNABLE TO BE REMOVED; THEREFORE, IT WAS PUSHED UP AGAINST THE VESSEL WALL WITH A STENT. PATIENT WAS TRANSFERRED TO CCU FOR CONTINUED CARDIAC MONITORING AND CARE, AND DISCHARGED 2 DAYS POST PROCEDURE. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VERRATA WIRE SEPARATED INSIDE THE PATIENT. ADDITIONAL INTERVENTION WAS PERFORMED; HOWEVER, THE SEPARATED TIP WAS RETAINED IN THE PATIENT (STENT).

  Patient problems: Foreign Body In Patient

  MAUDE report 16728699 ↗
• MalfunctionAug 31, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE IN A SLIGHTLY TORTUOUS VESSEL, THE VERRATA PLUS GUIDE WIRE WAS UNABLE TO ADVANCE DUE TO RESISTANCE ENCOUNTERED; THEREFORE, THE WIRE AND NON-MANUFACTURER'S INTRODUCER SHEATH WERE REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE WIRE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332504 ↗
• MalfunctionJun 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE, THE VERRATA 10185JP WIRE SIGNAL DISAPPEARED. A NEW VERRATA WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION USING A MICROSCOPE, A PORTION OF THE SENSOR WAS CRACKED AND MISSING WITH NO SHARP EDGES OBSERVED. ALTHOUGH IT WAS CONFIRMED THAT THE DEVICE WAS INTACT DURING USE, IT CANNOT BE DETERMINED AT 100% BECAUSE THE MISSING SENSOR IS NOT VISIBLE TO THE NAKED EYE. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN ABUNDANCE OF CAUTION DUE TO A PORTION OF THE SENSOR MISSING. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14662192 ↗
• MalfunctionNov 1, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, THE MANUFACTURER'S WIRE'S TIP APPEARED TO BE LONGER UNDER ANGIOGRAPHY. A SHARP EDGE WAS OBSERVED WHEN REMOVED FROM THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THE DISTAL COIL WAS STRETCHED AND CORE WIRE WAS BROKEN, BUT REMAINED INTACT TO THE WIRE. THE CORE WIRE WAS EXPOSED AND A SHARP EDGE WAS CONFIRMED. THIS PRODUCT PROBLEM IS BEING SUBMITTED FOR THE SHARP EDGE OBSERVED AT THE EXPOSED CORE WIRE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729701 ↗
• InjuryOct 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY DURING PULLBACK, THE WIRE GOT STUCK IN THE CORONARY VESSEL AND BROKE, PARTLY IN THE PROXIMAL LAD AND PARTLY IN THE AORTA. THE OPERATOR REMOVED HALF THE WIRE FROM THE PATIENT AND THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE THE OTHER HALF OF THE BROKEN WIRE. NO PIECE OF THE WIRE WAS RETAINED IN THE PATIENT. THE IFR/FFR WAS SUCCESSFULLY PERFORMED AND STENTS WERE PLACED AFTER THE INTERVENTION. THE PATIENT IS REPORTEDLY DOING FINE. NO RESISTANCE NOTED DURING DELIVERY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURER'S WIRE SEPARATED IN THE PATIENT AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689832 ↗
• MalfunctionOct 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE AFTER IFR MEASUREMENTS DURING PULLBACK, THE MANUFACTURER'S WIRE BROKE IN TWO PIECES WITHIN THE INTRODUCER SHEATH, BUT ABLE TO BE RETRIEVED FROM THE GUIDE CATHETER WITHOUT INTERVENTION. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE. NO PATIENT INJURY REPORTED, THE PATIENT RECEIVED NORMAL EXPECTED TREATMENT AND WAS DISCHARGED HOME. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURER'S WIRE SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585198 ↗
• MalfunctionSep 1, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT DURING A CORONARY DIAGNOSTIC PROCEDURE IN THE BODY POST NORMALIZATION AND PRE MEASUREMENT, THE MANUFACTURER'S GUIDEWIRE WAS STRETCHED. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. A LARGE PORTION OF THE DISTAL COIL WAS STRETCHED AND THE CORE WIRE WAS EXPOSED, AS A RESULT A SHARP EDGE WAS OBSERVED. THERE IS NO MISSING PARTS DETECTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EXPOSED CORE WIRE WITH A SHARP EDGE HAS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411271 ↗
• MalfunctionJul 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CORONARY DIAGNOSTIC PROCEDURE, THE MANUFACTURER''S GUIDEWIRE DISPLAYED THE ERROR MESSAGE "ATTACH WIRE TO CONNECTOR". THE WIRE WAS DETACHED AND CLEANED, THEN REATTACHED TO THE CONNECTOR; HOWEVER, THE ERROR MESSAGE REMAINED. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE. NO PATIENT INJURY REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED AND CONFIRMED A BROKEN AND MISSING SENSOR. THIS PRODUCT PROBLEM IS BEING SUBMITTED SINCE IT COULD NOT BE DETERMINED WHEN THE SENSOR SEPARATED FROM THE MANUFACTURER¿S DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236125 ↗
• MalfunctionMay 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE INSIDE THE BODY AFTER MEASUREMENT, THE MANUFACTURER'S GUIDE WIRE WAS PREPARED NORMALLY; CONNECTED TO PIM AND WAS ZEROED AND NORMALIZED. THE FIRST MEASUREMENT WAS PERFORMED WITHOUT ANY PROBLEMS. AFTER THE FIRST MEASUREMENT, WHEN SWITCHING TO THE SECOND VESSEL/LESION, THE PRESSURE WAS GONE. A SECOND MANUFACTURER'S GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. A PORTION (SMALLER THAN 0.02 MM) OF THE SENSOR WAS BROKEN AND MISSING. THIS PRODUCT PROBLEM IS BEING SUBMITTED SINCE IT COULD NOT BE DETERMINED WHEN THE SENSOR SEPARATED FROM THE MANUFACTURE¿S DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904782 ↗
• MalfunctionMay 28, 2021Material Separation; Material Separation

  IT WAS REPORTED DURING A CORONARY PROCEDURE INSIDE THE BODY BEFORE NORMALIZATION, THE MANUFACTURER'S GUIDE WIRE WAS USED TO TAKE A FEW RECORDINGS AND AFTER THE THIRD RECORDING, THE PA PRESSURE WAS UNABLE TO BE DETECTED. AN ATTEMPT TO RECONNECT THE MANUFACTURER'S GUIDE WIRE TO THE PIM WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT MANUFACTURER'S WIRE. NO PATIENT INJURY REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. A PORTION (LESS THAN 0.02 MM) OF THE SENSOR WAS CRACKED AND MISSING WITH ROUGH EDGES OBSERVED. DURING FUNCTIONAL TESTING, THE MANUFACTURER'S GUIDE WIRE FAILED THE ZERO TEST, THUS THE DRIFT TEST COULD NOT BE PERFORMED. THIS PRODUCT PROBLEM IS BEING SUBMITTED SINCE IT COULD NOT BE DETERMINED WHEN THE SENSOR SEPARATED FROM THE MANUFACTURE¿S DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904779 ↗
• MalfunctionMay 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE INSIDE THE BODY DURING MEASUREMENT POST NORMALIZATION, THE MANUFACTURER'S WIRE WAS ADVANCED THROUGH THE VESSEL WHEN THE PHYSICIAN NOTICED A LOSS OF TRACKABILITY AND CROSSABILITY WITH THE GUIDE WIRE. UPON REMOVAL, THE TIP WAS DAMAGED AND FRAYED, BUT REMAINED IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND MANUFACTURER'S WIRE. NO PATIENT INJURY REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THE DISTAL COIL WAS STRETCHED, THE CORE WIRE WAS BROKEN IN TWO PARTS, AND SHARP EDGES OF THE CORE WIRE WAS DETECTED, BUT NO MISSING PARTS WERE OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A BROKEN CORE WIRE WITH A SHARP EDGES HAS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806044 ↗
• MalfunctionApr 8, 2021Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURES POLICY. IT WAS REPORTED DURING A CORONARY PROCEDURE, INSIDE THE BODY, BEFORE NORMALIZATION, NO SIGNAL WAS RECEIVED AND NO PHYSICAL DAMAGE WAS OBSERVED. PER ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS INTACT UPON REMOVAL. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS BROKEN AND MISSING FROM THE DEVICE. THE PROBABLE CAUSE FOR THE SEPARATION MAY BE DUE TO THE DEVICE BEING DAMAGED DURING TRANSIT OR INITIAL UNPACKING. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED SINCE IT COULD NOT BE DETERMINED WHEN THE SENSOR SEPARATED FROM THE MANUFACTURES DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11639154 ↗
• InjurySep 19, 2020Entrapment of Device; Entrapment of Device

  THIS FOLLOW-UP REPORT #1 IS BEING SUBMITTED TO CORRECT THE LOT NUMBER AND UDI NUMBER FROM THE INITIAL REPORT SUBMITTED 09-19-2020, AND TO REPORT DEVICE ANALYSIS FINDINGS FOR THE DEVICE RECEIVED OCTOBER 1, 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10557778 ↗

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