Verrata Plus Pressure Guide Wire 10185PRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00845225002879), received between Mar 28, 2017 and Sep 26, 2024 — classified as 1 death, 18 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (20 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 41 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 23, 2020Entrapment of Device; Entrapment of Device

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO CORRECT AN INADVERTENT ENTRY ERROR IN G4, THE DATE RECEIVED BY MANUFACTURER (BECOMES AWARE DATE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312835 ↗
• InjuryJul 2, 2020Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO CORRECT AN INADVERTENT ENTRY ERROR IN G4, THE DATE RECEIVED BY MANUFACTURER (BECOMES AWARE DATE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10222468 ↗
• MalfunctionMar 20, 2020Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. IT WAS REPORTED DURING A DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY, AFTER MEASUREMENT, DURING PULLBACK,THE WIRE LOOKED STRANGE ON THE X-RAY PICTURE. WHEN THE PHYSICIAN REMOVED THE WIRE HE RECOGNIZED THAT THE TIP WAS UNWOUND. ADDITIONAL INFORMATION PROVIDED, THE PHYSICIAN KINKED THE WIRE BY PEELING OVER THE INTRODUCING NEEDLE, NO PORTION OF THE DEVICE BECAME SEPARATED, OR DETACHED WITHIN THE PATIENT, AND THE DEVICE WAS INTACT/IN ONE PIECE UPON REMOVAL. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE DISTAL COIL WAS STRETCHED, THE CORE WIRE WAS BROKEN IN TWO PARTS AND EXPOSED. ALL PIECES OF THE CORE WIRE WERE ACCOUNTED FOR. THE DAMAGE TO THE DISTAL COIL AND CORE WIRE LIKELY OCCURRED SOME TIME DURING PREPARATION OF THE DEVICE FOR USE. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED, AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE DAMAGE OBSERVED ON THE RETURNED DEVICE OF EXPOSED AND PROTRUDING COMPONENTS HAS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9861678 ↗
• MalfunctionMar 20, 2020Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. IT WAS REPORTED DURING A DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY, BEFORE NORMALIZATION, ERROR CODE 107 WAS RECEIVED. PER ADDITIONAL INFORMATION RECEIVED, NO PHYSICAL DAMAGE WAS OBSERVED AND THE DEVICE WAS INTACT UPON REMOVAL. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS MISSING FROM THE DEVICE. THE PROBABLE CAUSE FOR THE SEPARATION COULD NOT BE DETERMINED BY THE INVESTIGATION. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE 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 Known Impact Or Consequence To Patient

  MAUDE report 9861665 ↗
• MalfunctionFeb 14, 2020Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. IT WAS REPORTED DURING A DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY, BEFORE NORMALIZATION, THE DEVICE WAS NOT RECOGNIZED, NO SIGNAL. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS MISSING FROM THE DEVICE. THE PROBABLE CAUSE FOR THE SEPARATION COULD NOT BE DETERMINED BY THE INVESTIGATION. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE 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 Known Impact Or Consequence To Patient

  MAUDE report 9714641 ↗
• MalfunctionFeb 12, 2020Stretched; Material Split, Cut or Torn; Sharp Edges; Stretched; Material Split, Cut or Torn; Sharp Edges

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO ADVISE PERTINENT DEVICE ANALYSIS FINDINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9703577 ↗
• MalfunctionJan 31, 2020Disconnection

  IFR WIRE INITIALLY TRACING BUT THEN TRACING DISAPPEARED AND DIDN'T COME BACK. WIRE WAS DISCONNECTED AND RECONNECTED WITH NO IMPROVEMENT. NEW WIRE USED WITH NO DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9653087 ↗
• InjuryJan 26, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED DURING A DIAGNOSTIC CORONARY IFR PROCEDURE THE MANUFACTURER'S DEVICE WAS ADVANCED TO DISTAL LAD (LEFT ANTERIOR DESCENDING ARTERY) WHEN THE TIP WENT INTO SEPTAL BRANCH UNEXPECTEDLY, GOT STUCK AND COULD NOT BE REMOVED BY ITSELF. THEY EXCHANGED FROM 5FR. SYSTEM TO 6FR. AND A MICROCATHETER WAS INSERTED OVER THE DEVICE, ADVANCED BEYOND THE TIP AND THE MANUFACTURER'S DEVICE WAS REMOVED. EFFUSION AND A PERFORATION WERE OBSERVED UNDER ANGIOGRAM, A BALLOON CATHETER WAS INFLATED AND PLACED FOR 10 MINUTES. THEY CONFIRMED THE BALLOON WORKED WITH NO EFFUSION. THE PROCEDURE WAS FINISHED WITHOUT IFR MEASUREMENT. A PCI PROCEDURE IS SCHEDULED FOR THIS PATIENT AT A LATER DATE. VESSEL: HIGHLY TORTUOUS AND SEVERELY CALCIFIED LESION WITH 75% STENOTIC LESION WAS AT #7, LAD. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE MANUFACTURER'S DEVICE. ADDITIONALLY, THE PATIENT'S VESSEL WAS PERFORATED (WITH EFFUSION) REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: Perforation

  MAUDE report 9630538 ↗
• InjuryNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, DURING REMOVAL, THE PHYSICIAN COULD NOT RETRIEVE THE MANUFACTURER'S' DEVICE. THE DEVICE WAS RETRIEVED WITH ANOTHER MANUFACTURER'S' MICROCATHETER DEVICE. VESSEL: LEFT ANTERIOR DESCENDING ARTERY (LAD #6) WITH MODERATE STENOSIS, NOT TORTUOUS, SEVERE CALCIFIED THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE ADDITIONAL INTERVENTION VIA ANOTHER MANUFACTURER'S' MICROCATHETER DEVICE WAS REQUIRED TO RETRIEVE THE MANUFACTURE¿S DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376950 ↗
• InjurySep 24, 2019Stretched; Stretched

  IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, THE MANUFACTURER¿S DEVICE COULD NOT CROSS THE LESION IN THE LAD [LEFT ANTERIOR DESCENDING ARTERY]. THE DEVICE WAS REMOVED AND THE TIP WAS RESHAPED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION AGAIN BUT COULD NOT. THE DEVICE WENT INTO A SMALL VESSEL NEAR THE TARGET LESION AND WAS TRAPPED. THE DEVICE COULD NOT BE REMOVED, THEREFORE, THE PHYSICIAN EXCHANGED THE DIAGNOSTIC CATHETER WITH A GUIDING CATHETER. A GOOSE NECK SNARE WAS INSERTED INTO THE GUIDING CATHETER AND SUCCESSFULLY RETRIEVED THE MANUFACTURER¿S DEVICE. THE DISTAL PORTION WAS OBSERVED TO BE STRETCHED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE THE MANUFACTURER¿S DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112941 ↗
• InjurySep 22, 2019Material Separation; Material Separation

  IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, AFTER IFR MEASUREMENT AT LAD [LEFT ANTERIOR DESCENDING ARTERY], THE MANUFACTURER¿S DEVICE COULD NOT BE MOVED IN HIGH-LATERAL. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE WITH A MICROCATHETER RESULTING IN THE DISTAL PORTION SEPARATING IN THE MICROCATHETER. A 6FR GUIDING CATHETER AND GOOSE NECK SNARE WERE INSERTED SUCCESSFULLY RETRIEVING THE MICROCATHETER AND THE SEPARATED PORTION OF THE MANUFACTURER¿S DEVICE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE MANUFACTURE'S DEVICE SEPARATED IN THE PATIENT AND ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE THE SEPARATED PORTION OF THE DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9101888 ↗
• InjuryAug 7, 2019Entrapment of Device; Entrapment of Device

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO ADVISE PERTINENT DEVICE ANALYSIS FINDINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8872491 ↗