Eagle Eye Platinum ST RX Digital IVUS Catheter 85900PSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00845225002312), received between Jul 21, 2017 and Sep 3, 2026 — classified as 1 death, 14 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Material Separation” (50 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598168 ↗
• MalfunctionJan 6, 2026Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM (EEP) CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE. THE EEP CATHETER WAS LOADED OVER THE GUIDEWIRE, AND WHILE ADVANCING INTO THE GUIDE CATHETER, RESISTANCE WAS ENCOUNTERED, AND THE EEP CATHETER GOT STUCK; THEREFORE, REMOVED ALL TOGETHER. A NEW EEP CATHETER, GUIDEWIRE, AND GUIDE CATHETER WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM CATHETER AND CONCOMITANT DEVICES WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984637 ↗
• MalfunctionDec 10, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN A PERIPHERAL DIAGNOSTIC PROCEDURE IN THE PROXIMAL SUBCLAVIAN ARTERY. DURING WITHDRAWAL, THE CATHETER BECAME STUCK APPROX. 2/5 OF THE PROXIMAL LENGTH OF THE NON PHILIPS GUIDEWIRE. ATTEMPTS WERE MADE TO ADVANCE AND THEN RETRACT THE CATHETER, BUT WAS UNSUCCESSFUL; THEREFORE, REMOVED AS A SYSTEM. UPON REMOVAL, THE CATHETER AND GUIDEWIRE WERE MANUALLY FORCED APART, BUT IT WAS NOTED THAT THE CATHETER COULD NO LONGER IMAGE. THE USE THE CATHETER WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767842 ↗
• MalfunctionAug 21, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED SFA. DURING USE, THE CATHETER WOULD NOT ADVANCE OVER THE GUIDEWIRE AND BECAME DIFFICULT TO REMOVE; THEREFORE, WITHDRAWN TOGETHER. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM CATHETER AND A GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868761 ↗
• MalfunctionJun 24, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN AN EMERGENT CORONARY THERAPEUTIC PROCEDURE. DURING USE, A RINGDOWN ARTIFACT WAS OBSERVED AND WOULD NOT CLEAR AFTER THE DEVICE WAS RECONNECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER, NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED DURING AN EMERGENT CASE; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318311 ↗
• InjuryMar 27, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING ADVANCEMENT TO IN-STENT RESTENOSIS (ISR), THE CATHETER BECAME STUCK WITHIN THE STENT. TO REMOVE, THE SHAFT WAS CUT AND A NON-PHILIPS GUIDELINER WAS USED TO RELEASE THE CATHETER. UPON REMOVAL, A BURR AT THE CATHETER GUIDEWIRE EXIT PORT WAS OBSERVED. FLUOROSCOPY CONFIRMED THAT NO DEVICE REMNANTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM CATHETER WAS ENTRAPPED, AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712741 ↗
• InjuryFeb 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE. DURING USE, WHILE ADVANCING TO THE MODERATELY CALCIFIED LESION THROUGH THE ILIAC ARTERY, THE CATHETER SEPARATED INSIDE THE PATIENT. A SNARE WAS USED TO RETRIEVE THE SEPARATED PORTION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM CATHETER TIP SEPARATED INSIDE THE PATIENT, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416919 ↗
• MalfunctionJan 7, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM ST CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE IN THE PROXIMAL CIRCUMFLEX. DURING PULLBACK, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND REMOVED TOGETHER. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM ST CATHETER AND A NON-PHILIPS GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095802 ↗
• InjuryDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING PULLBACK, THE SHAFT SEPARATED BUT WAS SUCCESSFULLY REMOVED WITH A SNARE. ANGIOGRAPHY CONFIRMED NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EAGLE EYE CATHETER WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION REQUIRING INTERVENTION (SNARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21040122 ↗
• MalfunctionDec 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM ST CATHETER WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE IN A MODERATELY CALCIFIED MID LAD. DURING REMOVAL, RESISTANCE WAS NOTED AND THE DISTAL TIP BECAME DETACHED WITHIN THE NON-PHILIPS GUIDING CATHETER. THEREFORE, THE EAGLE EYE CATHETER AND GUIDING CATHETER WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER EAGLE EYE CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION, POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384244 ↗
• InjuryNov 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM ST WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN THE TIBIAL ARTERY AND SUPERFICIAL FEMORAL ARTERY. DURING PULLBACK, THE DISTAL TIP SEPARATED IN THE MID POPLITEAL, MEASURING APPROXIMATELY 2 MM IN LENGTH. THE SEPARATED DISTAL TIP WAS STENTED TO THE VESSEL WALL. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE DISTAL TIP SEPARATED INSIDE THE PATIENT. ADDITIONAL INTERVENTION WAS PERFORMED; HOWEVER, THE DISTAL TIP WAS RETAINED IN THE PATIENT (STENT).

  Patient problems: Foreign Body In Patient

  MAUDE report 18105802 ↗
• MalfunctionSep 14, 2023Material Separation; Sharp Edges; Material Separation; Sharp Edges

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A CORONARY PROCEDURE. AT THE BEGINNING OF THE PROCEDURE, THE CATHETER WORKED FINE; HOWEVER, IT STOPPED WORKING MID PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, A PORTION OF THE KAPTON WAS LIFTED AND MISSING WITH SHARP EDGES OF NON-MALLEABLE MATERIAL OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MISSING MATERIAL WITH SHARP EDGES OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750695 ↗
• InjuryMay 10, 2022Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PERIPHERAL PROCEDURE, RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE EAGLE EYE PLATINUM ST CATHETER WITHIN THE UPPER RIGHT ARM EXTREMITY. WHEN THE PHYSICIAN ATTEMPTED TO PULLBACK THE CATHETER, MORE RESISTANCE WAS ENCOUNTERED. ULTIMATELY, THE CATHETER SHEERED AND THE DISTAL TIP SEPARATED FROM THE CATHETER. THE PROXIMAL PORTION OF THE CATHETER WAS REMOVED AND THE 0.014¿ NON-MANUFACTURER GUIDE WIRE WAS BENT. THE SEPARATED TIP WAS REMOVED WITH A SNARE AND A FULL BODY FLUOROSCOPY CONFIRMED NO PIECE WAS RETAINED INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED AS EXPECTED IN GOOD CONDITION. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING INTERVENTION (SNARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347478 ↗
• MalfunctionMar 8, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A THERAPEUTIC CORONARY PROCEDURE, DURING REMOVAL OF THE MANUFACTURER'S CATHETER, IT GOT STUCK ON THE NON-MANUFACTURER'S WIRE. THEREFORE, THE ENTIRE SYSTEM WAS REMOVED AS A UNIT. 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 13698873 ↗
• MalfunctionJan 5, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, INSIDE THE BODY WHILE PASSING THROUGH THE LESION, THE MANUFACTURER'S CATHETER RECEIVED AN ERROR MESSAGE. THE CATHETER WAS REMOVED AS A SYSTEM AND UPON REMOVAL, A KINK WAS OBSERVED AT THE CATHETER TIP. THE PATIENT WAS REWIRED AND COMPLETED THE PROCEDURE WITH A PTCA DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURER''S CATHETER AND THE NON-MANUFACTURER''S GUIDEWIRE AND WERE REMOVED 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 13172279 ↗
• InjuryNov 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA, THE MANUFACTURER'S CATHETER ENCOUNTERED RESISTANCE AND COULD NOT BE ADVANCED OR RETRIEVED. UPON REMOVAL, THE CATHETER SEPARATED AND WAS RETRIEVED USING A NON MANUFACTURER'S MICRO CATHETER AND NON MANUFACTURER'S OTW BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE PATIENT WAS DISCHARGED AS EXPECTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE CATHETER SHAFT SEPARATION, REQUIRING ADDITIONAL INTERVENTION TO RETRIEVE THE SEPARATED PORTION OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815108 ↗
• InjuryOct 27, 2021Entrapment of Device; Entrapment of Device

  IT WAS A REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE, THE MANUFACTURER'S CATHETER GOT STUCK ON THE NON-MANUFACTURER'S GUIDE WIRE DUE TO A KINK IN THE GUIDE WIRE. THE PHYSICIAN CUT THE PROXIMAL END OF THE CATHETER AS AN ATTEMPT TO REMOVE THE CATHETER FROM THE GUIDE WIRE WITHOUT SUCCESS, THUS WAS REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS DISCHARGED AS EXPECTED WITH NO PATIENT INJURY REPORTED. THE ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE CATHETER WAS STUCK ON THE GUIDE WIRE AND ADDITIONAL INTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708172 ↗
• DeathMay 5, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE WHILE ADVANCING TO THE LESION, THE MANUFACTURER'S CATHETER COULD NOT CROSS THE LESION AND LOST IMAGE. AT SOME POINT AFTER THE MANUFACTURER'S CATHETER WAS REMOVED FROM THE PATIENT, A PERFORATION OCCURRED CAUSED BY A WIRE FROM A DIFFERENT MANUFACTURER, RESULTING IN PATIENT DEATH LATER THAT EVENING. THE PHYSICIAN STATED THAT THE MANUFACTURER'S CATHETER HAD NOTHING TO DO WITH THE PERFORATION IN THE ARTERY. THERE WAS NO DAMAGE OBSERVED ON THE MANUFACTURER'S DEVICE AFTER REMOVAL FROM THE PATIENT. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE MANUFACTURER¿S DEVICE IS A CONCOMITANT DEVICE IN A PROCEDURE WHERE A PATIENT DEATH FROM ANOTHER MANUFACTURE¿S DEVICE OCCURRED.

  Patient problems: Perforation of Vessels

  MAUDE report 11778675 ↗
• InjuryMay 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PERIPHERAL PROCEDURE, AN ERROR MESSAGE "CATHETER FAULT DETECTED " APPEARED. DUE TO THE ERROR MESSAGE, THE CATHETER WAS RETRIEVED. THE ANGIOGRAM CONFIRMED THE DISTAL TIP SEPARATED AND RETAINED IN THE PATIENT. A SNARE WAS USED AND THE DISTAL TIP WAS RETRIEVED. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761228 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED A PERFORATION REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: Cardiac Perforation

  MAUDE report 11634302 ↗
• InjuryMay 28, 2020Difficult to Remove; Difficult to Remove

  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 10098353 ↗
• MalfunctionFeb 27, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC PERIPHERAL PROCEDURE, INSIDE THE BODY, WHILE PASSING THROUGH THE LESION THE IMAGE WAS LOST. ANOTHER OF THE SAME PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED PER THE CUSTOMER COMPLAINT FORM INDICATED NO PART WAS DAMAGED AND NO DETACHED PARTS OBSERVED ON THE DEVICE AFTER REMOVAL FROM THE PATIENT. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THE PROXIMAL FILLET AND SCANNER WERE DAMAGED. A PORTION OF KAPTON WAS LIFTED NEAR THE SEAM SEAL, THE BACKING MATERIAL BENEATH THE LIFTED KAPTON WAS EXPOSED, NO MISSING BACKING MATERIAL OR KAPTON MATERIAL OBSERVED. THE PROBABLE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED DURING THE INVESTIGATION. HOWEVER, STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. IT COULD NOT BE DETERMINED WHEN THE DAMAGE OCCURRED. 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 THE MANUFACTURER¿S RE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9760430 ↗
• MalfunctionJan 13, 2020Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A THERAPEUTIC PERIPHERAL PROCEDURE THE IMAGE DISAPPEARED FROM THE MANUFACTURER'S DEVICE. A SECOND SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED PER THE CUSTOMER COMPLAINT FORM INDICATED NO PART WAS DAMAGED AND NO DETACHED PARTS OBSERVED ON THE DEVICE AFTER REMOVAL FROM THE PATIENT. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED AND DAMAGE WAS OBSERVED. THERE WAS A PORTION OF KAPTON MISSING, THE BACKING MATERIAL WAS EXPOSED ON THIS SECTION, SMALL ROUGH EDGES OF KAPTON MATERIAL WERE OBSERVED. THE PROBABLE CAUSE OF THE OBSERVED FAILURE COULD NOT BE DETERMINED. DEVICE MANIPULATION, IMPACT AND APPLIED PRESSURE ASSOCIATED WITH USE AND HANDLING CAN AFFECT THE INTEGRITY OF THE DEVICE. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE RETURNED DEVICE WAS MISSING MATERIAL AND HAD ROUGH EDGES. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9584542 ↗
• MalfunctionJan 29, 2019Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A PLANNED THERAPEUTIC PERIPHERAL PROCEDURE, INSIDE THE BODY, ADVANCING TO LESION, THE SHAFT OF THE MANUFACTURE'S DEVICE BENT. ANOTHER SAME MANUFACTURE'S DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE IS NO PATIENT INJURY. ACCESS LOCATION: FEMORAL. VISUAL AND MICROSCOPIC INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND DAMAGE WAS OBSERVED. IT WAS CONFIRMED ADHESIVE WAS MISSING ADHESIVE AT THE DISTAL AND PROXIMAL FILLETS. THE PROBABLE CAUSE OF THE MISSING ADHESIVE COULD NOT BE CONCLUSIVELY 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 PORTIONS OF THE ADHESIVE WERE MISSING FROM THE MANUFACTURE'S DEVICE AND IT COULD NOT BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285343 ↗
• MalfunctionJan 24, 2019Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A THERAPEUTIC DIAGNOSTIC PROCEDURE THE MANUFACTURER'S DEVICE LOST IMAGE. VISUAL, MICROSCOPIC INSPECTION, AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. PORTIONS OF ADHESIVE WERE MISSING ON THE DISTAL FILLET. ADHESIVE WAS PRESENT ON THE PZT ARRAY. THE DEVICE WAS RECOGNIZED BY THE SYSTEM BUT AN INCOMPLETE INTERMITTENT IMAGE WAS OBSERVED. THE PROBABLE CAUSE OF THE REPORTED LOST IMAGE FAILURE IS ADHESIVE PRESENT ON THE PZT ARRAY. THE PROBABLE CAUSE OF THE OBSERVED MISSING ADHESIVE ON THE DISTAL FILLET COULD NOT BE CONCLUSIVELY 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 ADHESIVE WAS MISSING FROM THE DEVICE, IT COULD NOT CONCLUSIVELY BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276545 ↗