Pioneer Plus Catheter PPLUS120 (UDI 00845225002565)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00845225002565), received between Oct 13, 2017 and Oct 27, 2025 — classified as 12 injuries, 29 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 18, 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.

• MalfunctionOct 27, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN SEVERELY CALCIFIED SFA. DURING USE, THE CATHETER WAS RECOGNIZED, HAD PARTIAL IMAGE BUT A CATHETER FAULT DETECTED ERROR MESSAGE APPEARED. THE CATHETER WAS UNPLUGGED/PLUGGED; HOWEVER, THE IMAGE WAS LOST. SINCE THE CATHETER WAS UNABLE TO CROSS THE LESION, THE PROCEDURE WAS ABORTED, AND RESCHEDULED AT A LATER DATE FOR THE ORIGINALLY PLANNED BYPASS. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23396698 ↗
• MalfunctionFeb 5, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT AN PIONEER CATHETER WAS USED IN AN EMERGENT THERAPEUTIC PERIPHERAL PROCEDURE. DURING USE, THE CATHETER WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH A NEW PIONEER CATHETER. NO PATIENT INJURY REPORT. 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 21318117 ↗
• MalfunctionDec 3, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT A PIONEER CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED MID AND DISTAL SFA. DUE TO THE PROCEDURE BEING KNOWN TO BE A TOUGH LESION TO CROSS, THERE WAS HIGH PROBABILITY THAT ALTERNATIVE ACCESS (PEDAL) WOULD BE NECESSARY. AN UNKNOWN DEVICE WAS USED, BUT UNABLE TO CROSS THE LESION. THE PHYSICIAN DECIDED A LAST ATTEMPT TO USE A PIONEER CATHETER. THE CATHETER WAS ABLE TO ADVANCE TO THE LESION, ATTEMPTED TO USE BUT WAS UNSUCCESSFUL. THEREFORE, THE CATHETER WAS REPOSITIONED AND DURING THAT TIME, THE IMAGE BECAME ERRATIC AND SOON FAILED TO PRODUCE AN IMAGE. THE PROCEDURE WAS STOPPED AND THE PHYSICIAN DECIDED TO GO WITH THE ORIGINAL PAN TO BRING THE PATIENT BACK AND ATTEMPT PEDAL ACCESS AT A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834031 ↗
• MalfunctionDec 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED LESION. WHILE ADVANCING TO THE LESION, THE NEEDLE TIP SEPARATED DUE TO SEVERE HEAVY CALCIUM. THE SEPARATED PORTION WAS REMOVED ALONG WITH THE CATHETER, WITH NO ADDITIONAL INTERVENTION REQUIRED. NO PART OF THE DEVICE WAS RETAINED INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED AS EXPECTED WITH NO INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MATERIAL SEPARATION. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20823709 ↗
• InjuryMar 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING USE, THE CATHETER BECAME KINKED AND APPROXIMATELY 4 CM OF THE DISTAL PORTION SEPARATED WITHIN THE PATIENT. AN ENDOVASCULAR SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE RETAINED DISTAL PORTION. FLUORO X-RAY CONFIRMED THAT NO PIECE WAS LEFT IN THE PATIENT. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960504 ↗
• InjuryMar 20, 2024

  WHILE BEING USED INSIDE THE PATIENT BY THE PHYSICIAN, THE END OF THE DEVICE WAS FOUND TO BE SEPARATED FROM THE WHOLE. THE DISTAL PIECE WAS BRIEFLY RETAINED, BUT ABLE TO BE RETRIEVED BY THE PHYSICIAN ENDOVASCULARLY. WHILE PERFORMING THE PROCEDURE, THE PHYSICIAN ELECTED TO USE THE VOLCANO IVUS SYSTEM WITH PIONEER-PLUS INTRAVASCULAR US GUIDED RE-ENTRY CATHETER. WHILE USING THE DEVICE, IT WAS IDENTIFIED THAT THE DISTAL END HAD COME APART FROM THE DEVICE ITSELF AND WAS LOCATED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO USE AN ENDOVASCULAR SNARE TO RETRIEVE THE RETAINED DISTAL END FROM INSIDE THE PATIENT. THE COMPLETE REMOVAL OF ANY REMAINING PIECES WAS VERIFIED UNDER FLUORO X-RAY. THE DEVICE AND ALL THE PIECES WERE REMOVED FROM THE STERILE FIELD AND PUT IN A PACKAGE FOR REPORTING.

  Patient problems: Foreign Body In Patient

  MAUDE report 18939720 ↗
• MalfunctionMar 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE, IN A SLIGHTLY CALCIFIED AND FIBROUS LESION. DURING RE-ENTRY, THE NEEDLE WAS UNABLE TO BE DEPLOYED. THEREFORE, THE CATHETER WAS REMOVED BUT GOT STUCK ON THE NON-PHILIPS GUIDEWIRE, AND REMOVED AS A SYSTEM. UPON REMOVAL, THE RAPID EXCHANGE PORT WAS DAMAGED. ANOTHER PIONEER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, IT WAS FOUND THAT THE POLYAMIDE MATERIAL WAS SEPARATED FROM THE CATHETER, BUT REMAINED INTACT TO THE NON-PHILIPS GUIDEWIRE. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MATERIAL SEPARATION. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899864 ↗
• MalfunctionOct 26, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PIONEER PLUS PPLUS120 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE TO TREAT A SLIGHTLY FIBROUS PROXIMAL SFA. AFTER USE, IT WAS NOTED THAT THE NEEDLE DID NOT FULLY RETRACT INSIDE THE BODY. SEVERAL ATTEMPTS WERE MADE TO PUSH THE NEEDLE TO RETRACT, BUT WAS UNSUCCESSFUL. THE CATHETER WAS REMOVED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE EXPOSED NEEDLE, RESULTING IN A SHARP EDGE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016226 ↗
• InjuryJul 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE TO TREAT A CTO IN THE PROXIMAL SFA. THE CATHETER WAS LOADED OVER A NON-PHILIPS GUIDEWIRE, AND THE GUIDEWIRE WENT SUBINTIMAL; HOWEVER, THE CATHETER WAS UNABLE TO COMPLETELY CROSS THE CTO LESION. ATTEMPTS WERE MADE FOR REENTRY, BUT COULD NOT ADVANCE FURTHER; THEREFORE IVUS WAS PERFORMED IN THE RIGHT DISTAL SFA. AFTER A FEW UNSUCCESSFUL ATTEMPTS TO ENTER THE TRUE LUMEN, THE PROCEDURE WAS ABANDONED. DURING REMOVAL, THE CATHETER GOT STUCK, AND THE DISTAL SHAFT SEPARATED INSIDE THE ILIAC ARTERY, BUT REMAINED INTACT TO THE GUIDEWIRE. ATTEMPTS WERE MADE FOR REMOVAL; HOWEVER, THE CATHETER AND THE GUIDEWIRE COULD NOT BE PULLED BACK INTO THE 7 FR SHEATH, AND BLOOD LOSS WAS NOTED LEADING TO ANEMIA. THE SHEATH WAS UPSIZED TO A 9 FR, AND WAS ABLE TO BE REMOVED AS A SYSTEM. X-RAY AND ANGIOGRAPHY CONFIRMED THAT NO PIECE OF THE CATHETER WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED AS EXPECTED. THE PHYSICIAN BELIEVED THAT THE CTO LIKELY CAUSED OR CONTRIBUTED TO THE CATHETER GETTING STUCK ON THE GUIDEWIRE, RESULTING IN THE SEPARATION. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO

  Patient problems: Anemia

  MAUDE report 17386288 ↗
• MalfunctionMay 1, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PIONEER PLUS PPLUS120 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE TO TREAT A SLIGHTLY CALCIFIED MID AND DISTAL SFA. AFTER ADVANCING TO THE TRUE LUMEN, THE NEEDLE WAS UNABLE TO FULLY RETRACT. AFTER MANY ATTEMPTS, THE CATHETER AND THE WIRE WERE REMOVED AS A SYSTEM, WITH 1.2 MM OF THE NEEDLE EXPOSED. THE CASE WAS ABORTED WITH NO PATIENT HARM, AND NO ADDITIONAL RISK TO THE PATIENT. THE PROCEDURE WILL BE RESCHEDULED AT A LATER DATE. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE EXPOSED NEEDLE, RESULTING IN A SHARP EDGE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850239 ↗
• MalfunctionMar 10, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PIONEER PLUS PPLUS120 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE TO TREAT A SEVERELY CALCIFIED SFA. AFTER SUCCESSFULLY RE-ENTERING THE TRUE LUMEN, THE CATHETER BECAME STUCK AND THE NEEDLE WAS UNABLE TO RETRACT. THE CATHETER WAS ABLE TO BE REMOVED WITH THE EXPOSED NEEDLE, WITH NO PATIENT INJURY REPORTED. THE CASE WAS COMPLETED WITH OTHER NON-PHILIPS DEVICES.  THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE EXPOSED NEEDLE, RESULTING IN A SHARP EDGE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527145 ↗
• MalfunctionFeb 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. THE CATHETER WAS ADVANCED THROUGH AN INTRODUCER SHEATH, AND ABOUT AN INCH INTO THE VESSEL, RESISTANCE WAS FELT. ADVANCEMENT WAS STOPPED AND DURING PULLBACK, RESISTANCE WAS FELT AGAIN INSIDE THE SHEATH. SOME DEGREE OF FORCE WAS APPLIED AND THE CATHETER WAS ABLE TO BE REMOVED FROM THE SHEATH. UPON INSPECTION OUTSIDE THE BODY, IT WAS NOTICED THAT THE DISTAL TIP SEPARATED, BUT REMAINED INTACT ON A NON-PHILIPS GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A NON-PHILIPS DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE DISTAL TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391927 ↗
• InjuryJul 18, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING PREPARATION FOR USE IN A THERAPEUTIC PERIPHERAL PROCEDURE, THE PIONEER PLUS CATHETER IMAGE WAS DISTORTED AND AN ERROR CODE "CATHETER FAULT IVACEPI4090 DETECTED. PLEASE REPLACE THE CATHETER." WAS PRESENT. DUE TO NO OTHER SIMILAR DEVICES AVAILABLE TO COMPETE THE CASE ENDOVASCULARLY, THE CASE WAS COMPLETED WITH SURGICAL BYPASS. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE DEVICE MALFUNCTION REQUIRING SURGICAL BYPASS TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048262 ↗
• InjuryJun 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE, AN ANGIOGRAM CONFIRMED THE PATIENT HAD A CTO IN THE MID SFA. THE PHYSICIAN ATTEMPTED TO CROSS WITH A WIRE, WENT SUBINTIMAL AND TRIED TO USE A PIONEER CATHETER BACK INTO THE TRUE LUMEN. HOWEVER, THE CATHETER DISTAL TIP SEPARATED, BUT WAS SUCCESSFULLY RETRIEVED USING A SNARE. NO PIECE OF THE CATHETER WAS LEFT IN THE PATIENT. THE PATIENT IS DOING OK AND WAS DISCHARGED AS EXPECTED. 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 14708620 ↗
• InjuryMar 31, 2022Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA, WHEN LOADING THE MANUFACTURER''S CATHETER ONTO THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED. THE CATHETER WAS TAKEN OUT, RE-FLUSHED AND RE-LOADED ONTO THE GUIDEWIRE WITH NO RESISTANCE. THEN, THE RE-ENTRY NEEDLE WAS DEPLOYED IN THE TARGET VESSEL AND A RE-ENTRY GUIDEWIRE WAS INSERTED THROUGH THE RE-ENTRY NEEDLE AND INTO THE TARGET VESSEL, BUT DID NOT PASS EASILY. THEN THE RE-ENTRY GUIDEWIRE WAS PULLED BACK AND THE NEEDLE WAS RETRACTED (UNCLEAR IF IT WAS FULLY RETRACTED). AN ATTEMPT WAS MADE TO PIN/PULL THE CATHETER OUT OVER THE RE-ENTRY GUIDEWIRE; HOWEVER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN PULLED HARDER ON THE CATHETER AND UPON REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE CATHETER HAD BROKEN OFF. UNDER FLUOROSCOPY, THE SEPARATED TIP WAS OBSERVED NEAR THE RE-ENTRY SITE IN THE SUBINTIMAL SPACE OUTSIDE OF THE TARGET LESION. THE PATIENT WAS HOSPITALIZED AND TAKEN TO THE OR FOR RETRIEVAL OF THE DEVICE; HOWEVER, THE SEPARATED TIP WAS UNABLE TO BE RETRIEVED. THE VESSEL WAS STENTED TO COVER THE SUBINTIMAL SPACE WHERE THE SEPARATED PORTION OF THE TIP WAS LOCATED AND JAILED IN THE VESSEL WALL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13970841 ↗
• MalfunctionMar 9, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN A SLIGHTLY CALCIFIED DISTAL SFA AND PROXIMAL POPLITEAL, THE MANUFACTURER'S CATHETER¿S NEEDLE DID NOT DEPLOY CORRECTLY. THE NEEDLE WAS FIRED AT 3 MM BUT COULD NOT BE ADVANCED TO THE TRUE LUMEN. THEREFORE, THE NEEDLE WAS RETRACTED AND THE WIRE WAS PULLED BACK IN TO ADJUST THE NEEDLE DEPTH TO 5 MM, WITH NO SUCCESS. THEN, THE CATHETER WAS ADVANCED FORWARD 1 CM AT A TIME, DEPLOYED THE NEEDLE AND REPEATED APPROXIMATELY 5 SEPARATE TIMES, AGAIN WITH NO SUCCESS. ANGIOGRAM SHOWED THAT THE NEEDLE APPEARED TO BE POINTING IN A DIFFERENT DIRECTION; HOWEVER, THERE WAS NO EVIDENCE OF NEEDLE PENETRATING THE INCORRECT VESSEL WALL. THE PHYSICIAN DECIDED TO REMOVE THE CATHETER, BUT IT GOT STUCK ON THE NON-MANUFACTURER'S WIRE, THUS WERE REMOVED TOGETHER AS A UNIT. THE NEEDLE WAS FULLY RETRACTED WHEN REMOVED FROM THE PATIENT. A NEW MANUFACTURER'S CATHETER AND NEW NON-MANUFACTURER''S WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURER'S CATHETER NEEDLE WAS NOT POINTING IN THE DESIRED DIRECTION. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716068 ↗
• MalfunctionNov 18, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE, THE MANUFACTURER'S CATHETER'S NEEDLE DID NOT DEPLOY. A SECOND MANUFACTURER'S CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THE NEEDLE WAS SLIGHTLY PROTRUDED, PRESENTING A SHARP EDGE. THIS PRODUCT PROBLEM IS BEING SUBMITTED FOR THE PROTRUDING NEEDLE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840692 ↗
• InjuryNov 10, 2021Entrapment of Device; Entrapment of Device

  INITIAL MDR REPORTED A RE-OCCLUSION OUT OF ABUNDANCE OF CAUTION. HOWEVER, PER THE ADDITIONAL INFORMATION RECEIVED ON 11/15/2021, THE OCCLUSION DID NOT LENGTHEN. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12784312 ↗
• MalfunctionOct 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE, DURING PULLBACK, THE MANUFACTURER'S CATHETER'S TIP BROKE IN TWO PIECES, BUT REMAINED INTACT TO THE NON-MANUFACTURER'S'S GUIDEWIRE. THE CATHETER AND GUIDEWIRE WERE REMOVED AS A UNIT AND A NEW MANUFACTURER'S CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISCHARGED IN NORMAL CONDITION. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TIP BROKE IN TWO PIECES. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677360 ↗
• MalfunctionSep 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO RE-ENTER THE TRUE LUMEN, THE PHYSICIAN REMOVED THE MANUFACTURER'S CATHETER FROM THE PATIENT. UPON REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE CATHETER SEPARATED WITHIN THE NON-MANUFACTURER'S SHEATH. THE TIP WAS REMOVED ALONG WITH THE NON-MANUFACTURER'S GUIDEWIRE AND SHEATH, AND WAS NOT LOST IN THE PATIENT. THE PHYSICIAN REINSERTED THE SHEATH AND GUIDEWIRE TO COMPLETE THE PROCEDURE WITH A NON-MANUFACTURER'S DEVICE. THE PATIENT WAS IN STABLE CONDITION AND DISCHARGED AS EXPECTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TIP SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435989 ↗
• MalfunctionJun 11, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE WHILE ADVANCING TO A CALCIFIED LESION, THE MANUFACTURER'S CATHETER WAS UNABLE TO BE POSITIONED IN THE DESIRED LOCATION AND THE CATHETER'S NEEDLE POPPED OUT AND WOULD NOT GO BACK INTO PLACE. UPON REMOVAL, THE PHYSICIAN CHECKED THE CATHETER'S NEEDLE AND THE NEEDLE DRIVER, AND IT WOULD NOT MOVE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE NEEDLE WAS UNABLE TO RETRACT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984508 ↗
• MalfunctionMay 24, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE INSIDE THE BODY WHILE ADVANCING THE LESION, THE MANUFACTURER'S CATHETER LOST IMAGE. THE PROCEDURE WAS COMPLETED WITH A NEW MANUFACTURER'S CATHETER. NO PATIENT INJURY REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. A PORTION OF THE TIP (APPROXIMATELY 0.25 SQUARE MM) WAS MISSING AND LIFTED WITH ROUGH EDGES OF MALLEABLE SHAFT MATERIAL. DURING FUNCTIONAL TESTING, THE DEVICE WAS RECOGNIZED BY THE IMAGING SYSTEM AND PRODUCED AN INCOMPLETE IMAGE. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A PORTION OF THE MANUFACTURE'S CATHETER WAS MISSING. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871541 ↗
• MalfunctionMay 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE INSIDE THE BODY WHILE PASSING THROUGH THE LESION, THE MANUFACTURER'S CATHETER'S IMAGE WAS INCOMPLETE AND 3/4 OF THE IMAGE WAS BLACKED OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY REPORTED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. A PORTION OF THE DISTAL SHAFT (LESS THAN 0.25 SQUARE MM) WAS MISSING AND LIFTED APPROXIMATELY 26 MM FROM THE DISTAL TIP WITH ROUGH EDGES OF MALLEABLE SHAFT MATERIAL. DURING FUNCTIONAL TESTING, THE DEVICE FAILED TO BE RECOGNIZED BY THE IMAGING SYSTEM AND THE SYSTEM AND DISPLAYED A ¿NO CATHETER¿ MESSAGE. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A PORTION OF THE MANUFACTURED'S DEVICE WAS MISSING. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845096 ↗
• MalfunctionDec 24, 2020Retraction Problem; Retraction Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED AFTER A THERAPEUTIC PERIPHERAL PROCEDURE, OUTSIDE PATIENT, AFTER USE, THE NEEDLE OF THE MANUFACTURES DEVICE WAS NOT FULLY RETRACTED. THERE WAS NO UNSCHEDULED INTERVENTION REQUIRED TO REMOVE THE DEVICE, NO ADVERSE EVENTS AND NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED, NO DAMAGE WAS NOTED TO THE DEVICE DURING PREPARATION; PRACTICE FIRING OF NEEDLE WAS DONE AND NEEDLE RETRACTED COMPLETELY WHEN TESTED. DEVICE WAS INSERTED INTO THE PATIENT ONCE, NEEDLE HAD BEEN FIRED TWICE AND REMOVED WITHOUT ANY DIFFICULTY ALONG WITH ANOTHER MANUFACTURES WIRE DEVICE DUE TO THE WIRE KINKING OUTSIDE THE BODY. A SECOND OF THE MANUFACTURES SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. LESION WAS 100% OCCLUSION IN THE PROXIMAL ANTERIOR TIBIAL (AT), NORMAL TORTUOUS ANATOMY FOR AT TAKE OFF, MODERATE CALCIFICATION PRESENT. PATIENT WAS DISCHARGED AS EXPECTED IN "GOOD" CONDITION. 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 NEEDLE REPORTEDLY DID NOT FULLY RETRACT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11072032 ↗
• MalfunctionDec 23, 2020Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A PLANNED THERAPEUTIC PERIPHERAL PROCEDURE, THE MANUFACTURES DEVICE COULD NOT BE REMOVED FROM ANOTHER MANUFACTURES WIRE DEVICE DURING PULLBACK, BOTH WIRE AND CATHETER WERE REMOVED TOGETHER, ALL PIECES INTACT. THE MANUFACTURES DEVICE WAS RE-INTRODUCED WITH A NEW WIRE. NO PATIENT INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURE WITH NO WIRE STUCK TO/IN IT. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED AND DAMAGE WAS OBSERVED. THE SCANNER BODY WAS SLIGHTLY BENT; NO SHARP OR ROUGH EDGE WERE OBSERVED. THE RX EXIT PORT WAS TORN AND STRETCHED; A SMALL PORTION OF RX EXIT PORT MATERIAL WAS MISSING FROM THE DEVICE. IT COULD NOT BE CONCLUSIVELY DETERMINED WHEN AND HOW THE RX EXIT PORT WAS DAMAGED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE RETURNED DEVICE WAS MISSING MATERIAL. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11064717 ↗