Penumbra System PSC054-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00814548012742), received between Mar 7, 2016 and Aug 28, 2020 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENUMBRA INC. BECAME AWARE ON 2019-04-15 DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES, OF A NEURORADIOLOGY JOURNAL TITLED, "THROMBECTOMY FOR ACUTE ISCHEMIC STROKE IN THE ELDERLY: A ''REAL WORLD'' EXPERIENCE." (ALAWIEH ET AL. 2018). IT WAS REPORTED THAT 336 PATIENTS UNDERWENT THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64), PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC), PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). ALL DATA WERE COLLECTED FROM A TERTIARY CENTER BETWEEN JANUARY 2013 AND NOVEMBER 2017. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: HEMORRHAGES AND DEATHS. THERE IS NO ALLEGATION WITHIN THE ARTICLE THAT A MALFUNCTION OF THE PENUMBRA SYSTEM OCCURRED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10468504 ↗
• InjuryNov 23, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE THROMBUS THROUGH THE LEFT CAROTID ARTERY. HOWEVER, THE PHYSICIAN THEN WAS UNABLE TO WITHDRAW THE 5MAXC AND NOTICED THAT THE VELOCITY AND GUIDEWIRE WERE STUCK. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE GUIDEWIRE AND FOUND THAT IT HAD BROKEN OFF WITHIN THE CATHETER, LEAVING A PORTION OF THE GUIDEWIRE WITHIN THE CATHETER. THE PHYSICIAN THEN SAW THROUGH IMAGING THAT THE ASPIRATION CATHETER HAD BECOME KINKED AT THE OPENING OF THE SHEATH AND, THEREFORE, WAS UNABLE TO BE RETRACTED. THEREFORE THE PHYSICIAN DID A CAROTID CUTDOWN TO REMOVE THE SHEATH WITH THE DAMAGED CATHETER AND WIRE INSIDE.

  Patient problems: No Code Available

  MAUDE report 8100119 ↗
• MalfunctionApr 5, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC) WAS BROKEN APPROXIMATELY 40CM FROM THE PROXIMAL HUB UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE 5MAXC WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAXC.

  Patient problems: No Patient Involvement

  MAUDE report 7399592 ↗
• MalfunctionAug 22, 2017Stretched; Aspiration Issue; Stretched; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING 5MAX REPERFUSION CATHETERS (5MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 5MAX IN THE TARGET VESSEL WITH NO ISSUE USING A NON-PENUMBRA 6F SHEATH. WHILE ATTEMPTING TO ASPIRATE THE THROMBUS USING THE ADAPT TECHNIQUE, THE PHYSICIAN NOTICED THAT THERE WAS NO CLOT COMING BACK IN THE CANISTER. HOWEVER, THE PHYSICIAN WAS CERTAIN THAT THE CLOT WAS ALREADY CAPTURED AT THE DISTAL TIP OF THE 5MAX; THEREFORE, THE 5MAX WAS SLOWLY PULLED BACK. IT WAS REPORTED THAT THE PHYSICIAN FELT LESS TENSION THAN USUAL WHILE REMOVING THE 5MAX. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE 5MAX WAS FLATTENED AND STRETCHED. THEREFORE, THE 5MAX WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING A NEW 5MAX AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811567 ↗
• MalfunctionApr 13, 2017Break; Physical Resistance; Break; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 (NEURON MAX) AND A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX). IT WAS REPORTED THAT THE PATIENT HAD AN EXTREMELY TORTUOUS AORTIC ARCH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE MAKING THE TURN FROM THE AORTIC ARCH INTO THE LEFT COMMON CAROTID ARTERY AND NOTICED THAT THE NEURON MAX BECAME KINKED MID/DISTAL SHAFT. HOWEVER, THE PHYSICIAN WAS ABLE TO RESOLVE ENOUGH OF THE KINK TO PASS A 5MAX, ANOTHER MANUFACTURER¿S CATHETER AND MICROCATHETER, AND A STENT RETRIEVER DEVICE THROUGH THE NEURON MAX. WHILE REMOVING THE 5MAX FROM THE NEURON MAX, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE AND IT WAS ASSUMED THE NEURON MAX MUST HAVE KINKED AGAIN. UPON COMPLETELY REMOVING THE 5MAX FROM THE NEURON MAX, THE PHYSICIAN NOTICED THAT THE TIP OF THE 5MAX HAD SHEARED OFF AND WAS STILL INSIDE THE NEURON MAX. THE PHYSICIAN THEN RE-WIRED THE NEURON MAX AND SUCCESSFULLY REMOVED THE FRAGMENTED 5MAX TIP WITHOUT ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME NEURON MAX AND THE OTHER MANUFACTURER¿S CATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6491551 ↗
• MalfunctionMar 17, 2017Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX) WAS SPLIT IN HALF AROUND THE MID-SHAFT UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE 5MAX WAS FOUND PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6414378 ↗
• MalfunctionFeb 17, 2017Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR AN ACUTE LIMB ISCHEMIA USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX). DURING THE PROCEDURE, WHILE USING A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT), THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S SHEATH INTO THE PATIENT AND THEN ADVANCED A 5MAX THROUGH IT TO REMOVE THROMBUS. THE PHYSICIAN DID NOT MENTION ANY RESISTANCE WHILE USING THE 5MAX. AFTER COMPLETING A PASS, THE PHYSICIAN REMOVED THE 5MAX AND NOTICED THAT IT WAS BROKEN APPROXIMATELY TWENTY CENTIMETERS FROM PROXIMAL HUB. THEREFORE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW 5MAX AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6339754 ↗
• MalfunctionFeb 3, 2017Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX). DURING THE PROCEDURE, USING A NON-PENUMBRA SHEATH, THE 5MAX BROKE INTO TWO PIECES APPROXIMATELY 10CM FROM THE DISTAL TIP IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) OF THE PATIENT. THE PHYSICIAN MADE NO ATTEMPT TO RETRIEVE THE DISTAL TIP OF THE 5MAX FROM WITHIN THE PATIENT, AND THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6300945 ↗
• MalfunctionDec 15, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PROXIMAL END OF THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX) WAS KINKED. THE KINKED 5MAX WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6175033 ↗
• MalfunctionSep 16, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 5MAX REPERFUSION CATHETERS (5MAX). DURING THE PROCEDURE, THE FIRST 5MAX WAS USED WITH A NEURON 6F 088 LONG SHEATH (NEURON MAX) FOR ASPIRATION. THE PHYSICIAN THEN RETRACTED THE 5MAX TO DO A PASS USING A STENT RETRIEVER AND NOTICED THAT THE 5MAX WAS KINKED. THEREFORE, THE PHYSICIAN CONTINUED THE PROCEDURE WITH A NEW 5MAX. WHILE ADVANCING THE SECOND 5MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUSPECTED THAT THE 5MAX HAD BECOME KINKED. THEREFORE, THE 5MAX WAS REMOVED AND WAS CONFIRMED TO BE KINKED UPON INSPECTION. THE PROCEDURE WAS THEN COMPLETED USING A THIRD 5MAX AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5958040 ↗
• MalfunctionSep 16, 2016Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 5MAX REPERFUSION CATHETERS (5MAX). DURING THE PROCEDURE, THE FIRST 5MAX WAS USED WITH A NEURON 6F 088 LONG SHEATH (NEURON MAX) FOR ASPIRATION. THE PHYSICIAN THEN RETRACTED THE 5MAX TO DO A PASS USING A STENT RETRIEVER AND NOTICED THAT THE 5MAX WAS KINKED. THEREFORE, THE PHYSICIAN CONTINUED THE PROCEDURE WITH A NEW 5MAX. WHILE ADVANCING THE SECOND 5MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUSPECTED THAT THE 5MAX HAD BECOME KINKED. THEREFORE, THE 5MAX WAS REMOVED AND WAS CONFIRMED TO BE KINKED UPON INSPECTION. THE PROCEDURE WAS THEN COMPLETED USING A THIRD 5MAX AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5957646 ↗
• MalfunctionAug 15, 2016Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX) WAS FRACTURED. THE FRACTURED 5MAX WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 5877551 ↗
• MalfunctionAug 4, 2016Break; Aspiration Issue; Break; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 5MAX REPERFUSION CATHETERS (5MAX). DURING THE PROCEDURE, WHILE USING THE 5MAX TO ASPIRATE THROMBUS, THE PHYSICIAN NOTICED THAT THE ASPIRATION WAS NOT WORKING AND DECIDED TO REMOVE THE 5MAX. AFTER REMOVAL OF THE 5MAX, THE PHYSICIAN NOTICED THAT THE MID SHAFT OF THE 5MAX WAS BROKEN. THE PHYSICIAN THEN CONTINUED THE PROCEDURE BY USING A NEW 5MAX; HOWEVER, THE SAME ISSUE OCCURRED. AFTER REMOVAL OF THE SECOND 5MAX, THE PHYSICIAN NOTICED THAT THE DISTAL SHAFT WAS BROKEN. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE WHILE USING BOTH 5MAX DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5848450 ↗
• MalfunctionAug 4, 2016Break; Aspiration Issue; Break; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 5MAX REPERFUSION CATHETERS (5MAX). DURING THE PROCEDURE, WHILE USING THE 5MAX TO ASPIRATE THROMBUS, THE PHYSICIAN NOTICED THAT THE ASPIRATION WAS NOT WORKING AND DECIDED TO REMOVE THE 5MAX. AFTER REMOVAL OF THE 5MAX, THE PHYSICIAN NOTICED THAT THE MID SHAFT OF THE 5MAX WAS BROKEN. THE PHYSICIAN THEN CONTINUED THE PROCEDURE BY USING A NEW 5MAX; HOWEVER, THE SAME ISSUE OCCURRED. AFTER REMOVAL OF THE SECOND 5MAX, THE PHYSICIAN NOTICED THAT THE DISTAL SHAFT WAS BROKEN. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE WHILE USING BOTH 5MAX DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5848440 ↗
• MalfunctionAug 4, 2016Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE DISTAL SHAFT OF THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX) WAS FRACTURED. THE FRACTURED 5MAX WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX.

  Patient problems: No Patient Involvement

  MAUDE report 5848432 ↗
• InjuryApr 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 054 SEPARATOR AND A VELOCITY DELIVERY MICROCATHETER. DURING THE PROCEDURE, RECANALIZATION WAS ACHIEVED WITHOUT ANY PROCEDURAL COMPLICATIONS. HOWEVER, ON POSTOPERATIVE DAY 1, A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) REPORTED HEMORRHAGIC TRANSFORMATION INTRACEREBRAL HEMORRHAGE (ICH) CONSIDERED TO BE A NON-SERIOUS ADVERSE EVENT RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE, BUT NOT RELATED TO THE INDEX STROKE. THE PATTERN OF THE HEMORRHAGE SUGGESTS THE POSSIBILITY OF VESSEL PERFORATION. THE PATIENT'S STAY WAS COMPLICATED BY CIRCULATORY SHOCK (HYPOVOLEMIC) ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2013. PATIENT FOLLOW-UP: ON (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH HYPOTENSION AND SEPTIC SHOCK WITH PULSELESS ELECTRICAL ACTIVITY ARREST AND WAS INTUBATED FOR AIRWAY PROTECTION DURING A CODE. THE PATIENT POST-ARREST MENTAL STATUS WAS MILDLY IMPROVED TO MINIMALLY RESPONSIVE STATE, +GAG, CORNEAL REFLEX, AND OCULOCEPHALIC, MOVING TO NOXIOUS STI

  Patient problems: Hemorrhage, Cerebral

  MAUDE report 5618575 ↗
• InjuryApr 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 5MAX SEPARATOR, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND A PENUMBRA SYSTEM 3MAX SEPARATOR. DURING THE PROCEDURE, THERE WAS SUSPICION OF TINY VESSEL PERFORATION IN LEFT M3 SEGMENT - DISTANT FROM THE SITE OF DEVICE PLACEMENT; HOWEVER, ANGIOGRAM WAS UNABLE TO CLEARLY CONFIRM THIS. THE FINAL RUNS SHOWED THAT THE VESSEL WAS RECANALIZED AND ALSO SHOWED A VASOSPASM. AT 14:25 HOURS, A FOLLOW UP COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED AND SHOWED A CIRCUMSCRIBED SUBARACHNOID HEMORRHAGE (SAH) AT THE LEFT INSULA. ON POSTOPERATIVE DAY 1, ANOTHER CT WAS PERFORMED AND REVEALED THAT THE SAH HAD NEARLY COMPLETELY RESOLVED AND ONLY TINY SPOTS OF SAH WAS SEEN IN LEFT DORSAL INSULA. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER. ON (B)(6) 2013, THE PATIENT WAS SEEN AGAIN FOR A FOLLOW UP VISIT AND EXAMINATION SHOWED NEUROLOGICAL AND FUNCTIONAL IMPROVEMENT. THE REPORTED VASOSPASM WAS REVIEWED AND ADJUDICATED BY THE COMMITTEE TO BE A NON-SERIOUS ADVERSE EVENT THAT WAS DEFINITELY RELATED TO THE ANGIOGRAPHIC PROCEDURE, AND

  Patient problems: Hemorrhage, Subarachnoid; Perforation of Vessels

  MAUDE report 5618403 ↗
• MalfunctionMar 7, 2016Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX) PLASTIC COVER WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE BROKEN 5MAX WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX.

  Patient problems: No Patient Involvement

  MAUDE report 5484791 ↗