Eagle Eye Platinum RX Digital IVUS Catheter 85900PRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00845225001278), received between May 4, 2017 and Sep 24, 2026 — classified as 1 death, 7 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Material Separation” (29 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891927 ↗
• MalfunctionMar 19, 2026Contamination

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED FOR A CORONARY PROCEDURE IN THE DISTAL RCA. DURING USE, RESISTANCE WAS ENCOUNTERED AND THE CATHETER COULD NOT PASS THE LESION; THEREFORE, REMOVED FROM THE PATIENT. UPON REMOVAL, A THREAD LIKE MATERIAL, APPROX. 1 CM IN LENGTH WAS OBSERVED COMING OUT OF THE CATHETER RAPID EXCHANGE PORT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN ABUNDANCE OF CAUTION BECAUSE A FOREIGN MATERIAL WAS FOUND ON THE CATHETER; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645562 ↗
• MalfunctionFeb 11, 2026Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A CORONARY THERAPEUTIC PROCEDURE. DURING USE, THE CATHETER WOULD NOT BACK OFF THE NON-PHILIPS GUIDEWIRE; THEREFORE, REMOVED TOGETHER. THE VESSEL WAS REWIRED AND A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 24315475 ↗
• MalfunctionDec 24, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE IN THE PROXIMAL LAD. WHILE ADVANCING THE CATHETER OVER THE NON-PHILIPS GUIDEWIRE, RESISTANCE WAS ENCOUNTERED. THE CATHETER GOT STUCK ON THE GUIDEWIRE; THEREFORE, WAS REMOVED AS A SYSTEM. A NEW CATHETER AND A GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM 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 23888236 ↗
• InjuryDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN A CORONARY PROCEDURE IN THE DISTAL AND MID CIRCUMFLEX. DURING USE, THE CATHETER TIP SEPARATED INSIDE A PREVIOUSLY PLACED STENT. A NEW STENT WAS PLACED TO SECURE THE TIP TO THE VESSEL WALL AND THE EXISTING STENT. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER TIP SEPARATED, REQUIRING ADDITIONAL INTERVENTION; RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23727881 ↗
• MalfunctionNov 18, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN AN EMERGENT CORONARY PROCEDURE. DURING USE, A STARBURST IMAGE WAS PRESENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN DEVICE. 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 23587084 ↗
• MalfunctionNov 3, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN AN EMERGENT CORONARY PROCEDURE. DURING USE, THE CATHETER WAS RECOGNIZED BY THE SYSTEM BUT IMAGE WAS LOST AT PULLBACK. THE CATHETER WAS UNPLUGGED/PLUGGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A NEW EAGLE EYE 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 23457543 ↗
• MalfunctionAug 4, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING ADVANCEMENT, NO IMAGES WERE PRODUCED. AFTER REBOOTING, THE CATHETER STILL FAILED TO CONNECT TO THE PIM. THEREFORE, A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, IT WAS OBSERVED THAT A PORTION OF THE KAPTON AND SCANNER BODY WERE EXPOSED WITH SHARP EDGES DETECTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A 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 22709900 ↗
• InjuryJul 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE. DURING REMOVAL, THE DISTAL TIP BROKE OFF WITHIN THE ILIAC ARTERY. ATTEMPTS TO RETRIEVE WITH A SNARE WERE UNSUCCESSFUL; THEREFORE, THE DISTAL TIP WAS STENTED IN PLACE WITHIN THE ARTERY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM CATHETER TIP SEPARATED, REQUIRING INTERVENTION, BUT WAS RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22468419 ↗
• MalfunctionMay 19, 2025Display or Visual Feedback Problem; Defective Device

  MEDICAL DOCTOR STATED THAT CATHETER WAS NOT WORKING, ONLY SHOWING 1/4 OF THE VESSEL VERSUS THE FULL 360 VIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043845 ↗
• MalfunctionJan 14, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN AN EMERGENT CORONARY THERAPEUTIC PROCEDURE. DURING USE, THE CATHETER HAD NO IMAGE DISPLAYED ON THE MONITOR. 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 21152012 ↗
• MalfunctionJan 6, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT AN EAGLE EYE CATHETER WAS USED IN AN EMERGENT CORONARY THERAPEUTIC PROCEDURE. DURING USE, AN ERROR MESSAGE WAS DISPLAYED ON THE MONITOR. 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 21079813 ↗
• MalfunctionNov 6, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE. WHILE ADVANCING TO THE LESION FOR A SECOND RUN, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDING CATHETER AND HAD TO BE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616642 ↗
• MalfunctionMay 15, 2024

  PATIENT BROUGHT TO CARDIAC CATHETERIZATION LAB (CCL), CLEANED AND PREPPED IN SURGICAL MANNER. GUIDEWIRE AND INTRAVENOUS ULTRASOUND (IVUS) CATHETER INSERTED INTO PATIENT. HOWEVER, THE GUIDEWIRE GOT STUCK IN IVUS CATHETER AND CAN'T BE REMOVED. BOTH GUIDEWIRE AND IVUS CATHETER WERE WITHDRAWN. BOTH DEVICES WERE EXCHANGED FOR SIMILAR ONES AND THE PROCEDURE WAS DONE WITHOUT ANY FURTHER INCIDENT. PATIENT TOLERATED PROCEDURE WELL AND WAS BROUGHT TO RECOVERY ROOM IN STABLE CONDITION. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, EAGLE EYE PLATINUM (PER SITE REPORTER). CATHETERIZATION LAB MANAGER INFORMED FIELD REPRESENTATIVE AFTER THE CASE AND ON THAT SAME DAY, FIELD REPRESENTATIVE CAME AND GOT THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320423 ↗
• MalfunctionNov 29, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE. AFTER FIRST USE, AN ERROR MESSAGE APPEARED, "CATHETER FAULT DETECTED. PLEASE DISCONNECT AND RECONNECT THE CATHETER OR PLUG IN A NEW CATHETER AND THEN PRESS THE RETRY BUTTON. IF THE PROBLEM PERSISTS SHUT DOWN THE SYSTEM AND CONTACT VOLCANO FIELD SERVICE." THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM; ATTEMPTS TO RECONNECT WERE UNSUCCESSFUL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, INSUFFICIENT ADHESIVE ON THE PROXIMAL FILLET WAS OBSERVED. THIS EXPOSED THE KAPTON, RESULTING IN SHARP EDGES OF NON-MALLEABLE MATERIAL. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO 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 18234726 ↗
• InjuryAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN THE LEFT PROXIMAL ILIAC ARTERY. DURING USE, THE CATHETER WAS UNABLE TO ADVANCE PAST THE LEFT ILIAC ARTERY. DURING PULL BACK, THE TIP BROKE OFF INSIDE THE PATIENT. HOWEVER, THE SEPARATED PORTION WAS SUCCESSFULLY REMOVED WITH A SNARE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION AND ADDITIONAL INTERVENTION (STENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569072 ↗
• MalfunctionApr 4, 2023No Display/Image

  IMAGE FROM EAGLE EYE IVUS CATHETER WOULD "FLICKER" AND EVENTUALLY WENT COMPLETELY BLACK. CATHETER WAS EXCHANGED FOR A NEW IVUS CATHETER AND THE PROBLEM RESOLVED. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, EAGLE EYE PLATINUM DIGITAL IVUS CATHETER (PER SITE REPORTER). LOOKING INTO THE PROBLEM. ASKED FOR RETURN OF DEVICE FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 16673100 ↗
• InjuryMar 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN EAGLE EYE PLATINUM CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED PROXIMAL RENAL ACCESSORY ARTERY. DURING USE, THE TIP OF THE CATHETER GOT STUCK AND BROKE OFF INSIDE THE PATIENT''S BODY. AN EMBOLIZATION OCCURRED ON THE RENAL ARTERY; HOWEVER, THERE WAS FLOW IN THE EMBOLIZED VESSEL. THE PHYSICIAN DID NOT TRY TO REMOVE THE SEPARATED TIP OR STENT IT TO THE VESSEL WALL. HE DID NOT THINK THAT THE RETAINED TIP WILL CAUSE ISSUES IF MOVED DOWN THE BLOOD STREAM. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION THAT WAS RETAINED IN THE PATIENT.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 16526248 ↗
• MalfunctionMay 18, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A CORONARY THERAPEUTIC PROCEDURE, THE EAGLE EYE PLATINUM CATHETER KINKED AND COULD NOT BE REMOVED FROM THE NON-MANUFACTURER GUIDE CATHETER. THE ENTIRE SYSTEM WAS REMOVED AS A UNIT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE EAGLE EYE PLATINUM CATHETER WAS REMOVED AS A SYSTEM THAT CAN RESULT IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428765 ↗
• InjuryDec 23, 2020Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  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 11070377 ↗
• MalfunctionJul 31, 2019Device Handling Problem; Device Handling Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT A DEVICE LABELED AS "DEMO" [DEMONSTRATION] AND "NOT FOR HUMAN USE" WAS USED DURING A PATIENT PROCEDURE. THE PRODUCT PERFORMED AS INTENDED AND NO INJURIES WERE REPORTED. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT IS DOING VERY WELL; NO COMPLICATIONS. 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 STERILITY OF THE DEVICE, AT THE TIME OF USE, CANNOT BE CONFIRMED BY THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8844408 ↗
• MalfunctionFeb 4, 2019Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING AN UNPLANNED THERAPEUTIC CORONARY PROCEDURE, AFTER FOUR RUNS, WHILE ADVANCING TO THE LESION, A CATHETER DETECTION FAIL ERROR OCCURRED ON THE MANUFACTURE¿S DEVICE. THE PHYSICIAN FOLLOWED THE INSTRUCTION TO DISCONNECT AND RECONNECT THE CATHETER AND PIM, BUT THE PROBLEM WAS NOT SOLVED. THE PHYSICIAN REPLACED THE NEW CATHETER THEN COMPLETED THE CASE. THERE IS NO PATIENT INJURY. FEMORAL ACCESS. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. A COUPLE OF SECTIONS OF ADHESIVE FROM THE PROXIMAL FILLET THAT TAPERS DOWN ON THE DISTAL SHAFT WAS LIFTED AND HAS ROUGH EDGES. IT WAS CONCLUDED THAT THE DEVICE WAS MISSING SOME ADHESIVE. THE PROBABLE CAUSE OF THE OBSERVED MISSING ADHESIVE ON THE PROXIMAL 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 THE MANUFACTURE¿S DEVICE WAS MISSING ADHESIVE. IT COULD NOT BE CONCLUDED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302659 ↗
• MalfunctionJan 24, 2019Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE, THE MANUFACTURER'S DEVICE PRODUCED A PARTIAL IMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND OF THE SAME MAKE AND MODEL. VISUAL, MICROSCOPIC INSPECTION, AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE DISTAL FILLET AND PZT ARRAY WERE SCRATCHED, SMALL PORTIONS OF ADHESIVE WERE MISSING. THE DEVICE WAS RECOGNIZED BY THE SYSTEM BUT NO IMAGE WAS PRODUCED. THE PROBABLE CAUSE OF THE REPORTED PARTIAL IMAGE FAILURE AND THE OBSERVED MISSING ADHESIVE IS THE OBSERVED DAMAGE TO THE DEVICE. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. HOWEVER, IT COULD NOT BE DETERMINED WHEN AND HOW THE DEVICE WAS DAMAGED. 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 8276190 ↗
• MalfunctionJan 15, 2019Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. INTERNAL REFERENCE: (B)(4). THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO REPORT ADDITIONAL INVESTIGATION FINDINGS, TO WIT: THERE IS NO POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR. THIS COMPLAINT WAS REASSESSED BASED ON AN ENGINEERING STUDY THAT INDICATED, THIS FAMILY OF CATHETERS DO NOT EXHIBIT ANY ADHESIVE DETACHMENT DURING NORMAL USE. THERE IS NO EVIDENCE OF ABNORMAL USE CONDITIONS, IT IS LIKELY THE ADHESIVE DETACHED POST-PROCEDURE, DURING THE PROCESS OF RETURNING THE DEVICE FOR ANALYSIS. THERE WAS NO PATIENT INJURY, NO STATUS DECLINE, NO ADVERSE EVENT, AND NO UNPLANNED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REPORTED. THERE IS NO POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8250964 ↗
• MalfunctionDec 15, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. INTERNAL REFERENCE: (B)(4). THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO REPORT ADDITIONAL INVESTIGATION FINDINGS, TO WIT: THERE IS NO POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR. THIS COMPLAINT WAS REASSESSED BASED ON AN ENGINEERING STUDY THAT INDICATED, THIS FAMILY OF CATHETERS DO NOT EXHIBIT ANY ADHESIVE DETACHMENT DURING NORMAL USE. THERE IS NO EVIDENCE OF ABNORMAL USE CONDITIONS, IT IS LIKELY THE ADHESIVE DETACHED POST-PROCEDURE, DURING THE PROCESS OF RETURNING THE DEVICE FOR ANALYSIS. THERE WAS NO PATIENT INJURY, NO STATUS DECLINE, NO ADVERSE EVENT, AND NO UNPLANNED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REPORTED. THERE IS NO POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8167757 ↗