Zoom Catheter ICRC071137Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00812212030450), received between Feb 24, 2022 and Jun 30, 2026 — classified as 3 deaths, 27 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Break; Material Separation; Detachment of Device or Device Component

  DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR A LEFT PROXIMAL M1 OCCLUSION, ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY USING A THIRD-PARTY ACCESS GUIDE CATHETER. DURING THE SECOND PASS, RESISTANCE WAS ENCOUNTERED WHILE WITHDRAWING THE ZOOM 71 THROUGH THE THIRD-PARTY GUIDE CATHETER. IT WAS REPORTED THAT THE THIRD-PARTY GUIDE CATHETER HAD KINKED, CAUSING THE DISTAL TIP OF THE ZOOM 71 TO FRACTURE NEAR THE KINK SITE. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED USING AN ADDITIONAL ASPIRATION CATHETER. THE PHYSICIAN THEN EXCHANGED FOR AN ALTERNATIVE THIRD-PARTY DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT REMAINED STABLE FOLLOWING THE EVENT, WITH NO REPORTED ADVERSE CLINICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672889 ↗
• MalfunctionApr 23, 2026Break; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR M1 SEGMENT, THE ZOOM 71 CATHETER WAS REMOVED AND OBSERVED TO HAVE UNRAVELED OUTSIDE THE PATIENT. A TOTAL OF TWO PASSES WERE PERFORMED, WITH THE ISSUE OCCURRING ON THE SECOND PASS. UPON REMOVAL, DAMAGE WAS IDENTIFIED APPROXIMATELY 4 CM FROM THE DISTAL TIP. RESISTANCE WAS ENCOUNTERED DURING RETRACTION THROUGH THE THIRD PARTY ROTATING HEMOSTATIC VALVE (RHV). THE PHYSICIAN USED ANOTHER ZOOM 71 TO COMPLETE THE PROCEDURE. THE CASE INVOLVED SIGNIFICANT VESSEL TORTUOSITY; HOWEVER, IT IS UNKNOWN WHETHER PATIENT ANATOMY DIRECTLY CONTRIBUTED TO THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS POOR BUT WAS ASSESSED AS UNRELATED TO THE DEVICE ISSUE. PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974574 ↗
• DeathFeb 12, 2026Material Deformation

  THROMBECTOMY WAS PERFORMED FOR AN M1 STROKE. THE PHYSICIAN UTILIZED A THIRD-PARTY WIRE, ZOOM SIM AND ZOOM 88. THE 88 REMAINED LOW IN THE CERVICAL ICA WHILE A ZOOM 71, THIRD-PARTY MICROCATHETER AND THIRD-PARTY NEURO WIRE WERE ADVANCED TO THE CLOT. MANUAL ASPIRATION WAS PERFORMED WITH A SYRINGE THROUGH ZOOM 71 WHEN THE PHYSICIAN FELT RESISTANCE AND SLIPPING OF THE ZOOM 88 AND THE PHYSICIAN LOST ACCESS. PHYSICIAN REMOVED EVERYTHING INCLUDING THE ZOOM 88. HE WENT BACK UP WITH A THIRD-PARTY ACCESS CATHETER AND A NEW ZOOM 71 AND WAS ABLE TO OPEN THE M1 SUCCESSFULLY. THERE WERE DISTAL BLOCKAGES THAT HE ATTEMPTED TO REACH WITH A ZOOM 55 UNSUCCESSFULLY, AT WHICH POINT THE PROCEDURE WAS STOPPED. POST PROCEDURE, IT WAS NOTICED THAT THE ZOOM 88 WAS KINKED MID-SHAFT AND THE ORIGINAL ZOOM 71 WAS KINKED NEAR THE DISTAL TIP. THE KINKS ON THE ZOOM CATHETERS WERE ATTRIBUTED TO THE PATIENT'S TORTUOUS ANATOMY AND DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. THE THIRD-PARTY FEMORAL SHEATH WAS ALSO KINKED AT THE GROIN ACCESS SITE. POST PROCEDURE, AN INTERCRANIAL PERFORATION WAS IDENTIFIED. ADDITIONALLY, POST PROCEDURE A RLE (RIGHT LOWER EXTREMITY) ISCHEMIA WAS NOTED, AND A HEAD CT WAS PERFORMED WHICH CO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 24325250 ↗
• InjuryJan 21, 2026Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY OF THE LEFT M1 SEGMENT. THE INTERNAL CAROTID ARTERY (ICA) WAS NOTED TO BE HIGHLY TORTUOUS DISTAL TO THE BIFURCATION. ADVANCEMENT OF THE ZOOM 88, ZOOM 71 AND THIRD-PARTY STENT RETRIEVAL WAS PERFORMED SUCCESSFULLY. DURING THE REMOVAL OF ZOOM 71 AND THIRD-PARTY STENT RETRIEVER, SIGNIFICANT RESISTANCE WAS FELT, AND THE ZOOM 71 COULD NOT BE WITHDRAWN WHICH RESULTED IN REMOVAL OF THE THIRD-PARTY STENT RETRIEVER, ZOOM 88 AND THE ZOOM 71 AS A SYSTEM. THE ZOOM 71 WAS FOUND TO BE FRACTURED INTO TWO SEGMENTS; HOWEVER, ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. FOLLOWING REMOVAL OF THE DEVICE, SOME EXTRAVASATION WAS OBSERVED IN THE PATIENT. THE PROCEDURE COULD NOT BE COMPLETED.

  Patient problems: Extravasation

  MAUDE report 24138975 ↗
• InjurySep 11, 2025Break; Material Separation; Use of Device Problem; Failure to Advance; Break; Material Separation; Use of Device Problem; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN M1 STROKE. A THIRD-PARTY ACCESS CATHETER WAS USED AND POSITIONED IN THE LOW TO MID CERVICAL INTERNAL CAROTID ARTERY (ICA). A ZOOM 71 WAS ADVANCED TOWARDS THE M1 OVER A ZOOM 35- AND THIRD-PARTY GUIDEWIRE. THE ZOOM 71 REACHED THE M1 AND WAS UNABLE TO ADVANCE FURTHER. UPON REVIEW THE PHYSICIAN NOTICED THE ZOOM 71 HAD PROLAPSED IN THE CERVICAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ATTEMPTED TO RETRACT THE ZOOM 71 TO STRAIGHTEN THE CATHETER. DURING THIS ATTEMPT, THE DEVICE BECAME IMPINGED AGAINST THE THIRD-PARTY ACCESS CATHETER AND SEPARATED. A SNARE WAS USED TO RETRIEVE THE DISTAL SEGMENT OF THE ZOOM 71 SUCCESSFULLY. THE PROCEDURE WAS THEN COMPLETED USING A NEW ZOOM 71 CATHETER. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23029505 ↗
• InjuryAug 25, 2025Break; Material Separation; Material Deformation; Break; Material Separation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT MECHANICAL THROMBECTOMY FOR THE REMOVAL OF CLOT IN THE MIDDLE CEREBRAL ARTERY (MCA) AND ANTERIOR CEREBRAL ARTERY (ACA). DURING THE FIRST PASS, THE ZOOM 71 CATHETER BROKE AT THE DISTAL END. A NEW ZOOM 71 CATHETER WAS UTILIZED WITH A THIRD-PARTY DEVICE TO CONTINUE THE PROCEDURE FOR REMOVAL OF CLOT. DURING THE THIRD PASS, THE SECOND ZOOM 71 CATHETER ALONG WITH THE THIRD-PARTY DEVICE WAS USED TO RETRIEVE THE DISLODGED PORTION OF THE INITIAL ZOOM 71 CATHETER. SUBSEQUENTLY, TWO ADDITIONAL PASSES WERE PERFORMED IN THE ACA WITH ZOOM 45 CATHETER TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S ANATOMY WAS TORTUOUS DUE TO A LOOP IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) AND RESISTANCE WAS ENCOUNTERED DURING RETRACTION OF THE ZOOM 71. POST PROCEDURE, THE PATIENT EXPERIENCED ARTERIAL SPASM POSSIBLY RELATED TO HISTORY OF DRUG USE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22889998 ↗
• InjuryJun 12, 2025Break; Material Separation; Break; Material Separation

  AN 85-YEAR-OLD-MALE WAS TREATED FOR MECHANICAL THROMBECTOMY TO REMOVE AN OCCLUSION FROM THE RIGHT M1 SEGMENT. THE PATIENT'S ANATOMY WAS REPORTEDLY TORTUOUS. ACCESS WAS OBTAINED USING A THIRD-PARTY ACCESS CATHETER WHICH WAS ADVANCED TO THE FIRST BIG TURN IN THE TORTUOUS LOOP IN DISTAL CERVICAL ICA. THE ZOOM 71 WAS THEN ADVANCED OVER A THIRD-PARTY GUIDEWIRE AND ZOOM 35 TO THE CLOT AT THE PROXIMAL M1 SEGMENT. THE GUIDEWIRE AND ZOOM 35 CATHETER WERE REMOVED. ASPIRATION WAS PERFORMED WITH THE ZOOM 71 CATHETER. AS THE ZOOM 71 CATHETER WAS RETRACTED UNDER ASPIRATION AND THE CLOT WAS REMOVED. DURING THE REMOVAL OF THE ZOOM 71 CATHETER, THE PHYSICIAN FELT RESISTANCE BUT KEPT PULLING BACK THE CATHETER. AS THE PHYSICIAN PULLED BACK ON THE ZOOM 71, THE CATHETER BROKE AROUND 22CM FROM THE DISTAL TIP OF THE CATHETER. A SNARE WAS USED TO RETRIEVE THE BROKEN SEGMENT BUT WAS UNSUCCESSFUL. A STENT RETRIEVER WAS THEN USED TO RETRIEVE THE BROKEN SEGMENT, HOWEVER DURING THE RETRIEVAL ATTEMPT ONLY THE DISTAL 2 CM OF THE BROKEN SEGMENT WAS ABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED. A DAY OR TWO LATER THE PATIENT WAS RETURNED TO THE CATH LAB AND THE PHYSICIAN ATTEMPTED TO USE ASPIRATION AND A STEN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22199497 ↗
• InjuryJun 4, 2025Break; Material Separation; Break; Material Separation

  A 37-YEAR-OLD FEMALE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY TO REMOVE AN OCCLUSION AT THE RIGHT M1 SEGMENT. ACCESS WAS OBTAINED USING A ZOOM TRACSTAR ACCESS CATHETER. A ZOOM 71 CATHETER WAS ADVANCED THROUGH THE ACCESS CATHETER OVER A THIRD-PARTY GUIDEWIRE TO THE FACE OF THE CLOT. THE FIRST PASS ASPIRATION WAS COMPLETED WITHOUT ANY ISSUES. ON THE SECOND PASS THE PHYSICIAN FELT RESISTANCE AS HE BEGAN TO RETRACT THE ZOOM 71 CATHETER. THE ZOOM 71 CATHETER BROKE APPROXIMATELY 8-10 CM FROM TIP. THE BROKEN CATHETER PIECE WAS RETRIEVED WITH A THIRD-PARTY MICROCATHETER AND STENT RETRIEVER. THE PATIENT WAS THEN STENTED IN THE M1 SEGMENT DUE TO A VESSEL DISSECTION THAT WAS UNRELATED TO THE ZOOM CATHETERS. THE PATIENT WAS REPORTED TO BE DOING WELL. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION BUT WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146514 ↗
• InjuryApr 30, 2025Break; Material Separation; Break; Material Separation

  A 71-YEAR-OLD MALE PRESENTED WITH A DISTAL M1 OCCLUSION. ACCESS WAS OBTAINED USING AN 8F SHEATH AND A ZOOM 88 SUPPORT ACCESS CATHETER. THE PATIENT HAD A 360-DEGREE LOOP IN THE CERVICAL INTERNAL CAROTID ARTERY (ICA). A ZOOM 71 WITH A ZOOM 35 WERE ADVANCED TO THE FACE OF THE CLOT IN THE M1 SEGMENT THROUGH THE ZOOM 88 SUPPORT CATHETER. THREE PASSES WERE ATTEMPTED WITH THE ZOOM 71 AND NO CLOT WAS REMOVED. THE PHYSICIAN REMOVED THE ZOOM 35 AND SWAPPED IT WITH A THIRD PARTY MICROCATHETER AND STENT RETRIEVER. THE ZOOM 88 SUPPORT WAS POSITIONED IN THE PETROUS ICA AND THE PHYSICIAN USED THE SOLUMBRA TECHNIQUE IN AN ATTEMPT TO REMOVE THE CLOT. SIGNIFICANT RESISTANCE WAS FELT IMMEDIATELY WHEN RETRACTING THE STENT RETRIEVER AND ZOOM 71 BACK TOGETHER. ADDITIONAL FORCE WAS APPLIED TO THE RETRACT THE STENT RETRIEVER AND ZOOM 71 INTO THE ZOOM 88 SUPPORT. THE DISTAL PORTION OF THE ZOOM 71 BROKE AND IT REMAINED IN THE PATIENT. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN PIECE BUT WERE UNSUCCESSFUL. THE PHYSICIAN CONFIRMED THERE WAS BLOOD FLOW PAST THE BROKEN SEGMENT, HOWEVER THE ORIGINAL OCCLUSION IN THE DISTAL M1 WAS STILL PRESENT. THE PHYSICIAN CONSULTED WITH A VASCULAR SURGEON ABOUT REMOVAL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21939740 ↗
• MalfunctionApr 17, 2025Break; Material Separation; Break; Material Separation

  A ZOOM 71 WAS UTILIZED TO TREAT AN OCCLUSION AT THE M1 SEGMENT. INITIAL ANGIOGRAM APPEARS TO SHOW SOME NARROWING IN THE INTERNAL CAROTID ARTERY (CAUSE UNKNOWN). THE PATIENT HAD NO STENOSIS OR SIGNIFICANT CALCIFICATIONS; HOWEVER, THE ANATOMY WAS TORTUOUS WITH A BOVINE ARCH AND 90°ANGLE JUST ABOVE THE CAROTID BULB. ACCESS OBTAINED WITH ZOOM 88 SUPPORT WHICH WAS PARKED LOW IN THE INTERNAL CAROTID ARTERY (ICA). ZOOM 71 WAS DELIVERED OVER A THIRD-PARTY MICRO CATHETER AND THIRD-PARTY GUIDEWIRE TO THE M1 CLOT THROUGH THE ZOOM 88 SUPPORT WITH NO RESISTANCE. ASPIRATION WAS PERFORMED WITH THE ZOOM 71. WHILE RETRACTING THE ZOOM 71 INTO THE ZOOM 88 SUPPORT, THE PHYSICIAN FELT RESISTANCE. HE STOPPED AND REMOVED THE ZOOM 71 AND ZOOM 88 SUPPORTS AS A SYSTEM FROM THE PATIENT. OUTSIDE THE PATIENT THE DOCTOR ATTEMPTED TO PULL WITH FORCE TO REMOVE THE ZOOM 71 FROM THE ZOOM 88 SUPPORT. THE ZOOM 71 BROKE OUTSIDE OF THE PATIENT APPROXIMATELY 10CM FROM THE DISTAL TIP. NO KINKS OR DAMAGE WERE OBSERVED ON THE ACCESS CATHETER, GUIDEWIRE, OR MICROCATHETER. THE CASE WAS COMPLETED WITH A THIRD-PARTY ASPIRATION CATHETER AND STENT. THERE WAS NO PATIENT SEQUELAE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861325 ↗
• InjuryApr 11, 2025Fracture; Difficult to Remove; Material Deformation

  IMPERATIVE CARE ZOOM 71 REPERFUSION CATHETER DISTAL FRACTURED LEADING TO RETAINED PORTION IN THE PT'S CERVICAL ICA LOOP TO THE DISTAL RIGHT M1 SEGMENT. THE PT PRESENTED WITH AN ACUTE DISTAL RIGHT M1 CEREBRAL OCCLUSION AND WAS TAKEN FOR MECHANICAL THROMBECTOMY. A ZOOM 88 ASPIRATION CATHETER WAS POSITIONED IN THE PETROUS INTERNAL CAROTID ARTERY FROM A RIGHT GROIN ACCESS PAST A 380 DEGREE VASCULAR LOOP IN THE UPPER RIGHT CERVICAL ICA. THREE IMPERATIVE CARE PUMP ASPIRATION ONLY PASSES WERE PERFORMED USING ZOOM 71 ASPIRATION CATHETER IN COMBINATION WITH ZOOM 35 ASPIRATION CATHETER WHICH WERE UNSUCCESSFUL TO REMOVE THE THROMBUS. THEN, A FOURTH PASS WAS PERFORMED USING A VELOCITY MICRO CATHETER WHICH WAS USED TO DEPLOY A STRYKER 4 MM X 28 MM TREVO NXT STENT RETRIEVER OVER THE THROMBUS, AND THE ZOOM 71 ASPIRATION WAS ADVANCED TO THE THROMBUS INTERFACE, AND THE ZOOM 71 WAS CONNECTED TO PUMP ASPIRATION AFTER REMOVAL OF THE VELOCITY MICRO CATHETER. AFTER TWO MINS, THE RETRIEVER AND ZOOM 71 CATHETER WERE WITHDRAWN TOGETHER. DURING THE PULL BACK OF THE THROMBUS, THERE WAS TENSION GENERATED WHICH RESULTED IN THE ZOOM 71 CATHETER FRACTURING IN THE CERVICAL ICA LOOP. THE RETRIEVER WAS SUCCESSFULLY

  Patient problems: Foreign Body In Patient; Myocardial Infarction; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21827525 ↗
• MalfunctionDec 30, 2024Break; Material Separation; Break; Material Separation

  A 56-YEAR-OLD FEMALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE M1 SEGMENT. ACCESS WAS OBTAINED WITH A GUIDEWIRE AND A ZOOM 88 CATHETER. DURING THE FIRST PASS, A ZOOM 71 CATHETER AND A STENT RETRIEVER WERE ADVANCED TO THE M1 SEGMENT. AFTER ASPIRATION WAS APPLIED, THE STENT RETRIEVER WAS RETRACTED INTO THE ZOOM 71. BOTH DEVICES WERE THEN PULLED BACK AND REMOVED TOGETHER THROUGH THE ZOOM 88. THE PHYSICIAN STATED THAT WHILE PULLING BACK THE DEVICES THROUGH THE ZOOM 88, THE DEVICES GOT STUCK IN THE Y ADAPTER OF THE THIRD PARTY ROTATING HEMOSTATIC VALVE (RHV). THE PHYSICIAN CONTINUED RETRACTING THE DEVICES RESULTING IN THE ZOOM 71 SHAFT SEPARATING. THE PHYSICIAN CONFIRMED THAT THE SEPARATION OCCURRED OUTSIDE OF THE PATIENT. A SECOND PASS WAS COMPLETED USING A NEW ZOOM 71 CATHETER. IT WAS ADVANCED OVER THE SAME GUIDEWIRE, THROUGH THE SAME RHV, AND SAME ZOOM 88 CATHETER. THE SAME STENT RETRIEVER WAS THEN ADVANCED THROUGH THE NEW ZOOM 71 TO THE M1 SEGMENT, AND THE SAME STEPS AS THE FIRST PASS WERE PERFORMED. AFTER ASPIRATION WAS APPLIED, THE PHYSICIAN AGAIN RETRACTED THE STENT RETRIEVER INTO THE ZOOM 71 AND PULLED BOTH DEVICES BACK TOGETHER THROUGH THE ZOOM 88 AND RHV. THE DEVICES BECAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037093 ↗
• MalfunctionOct 30, 2024Material Separation; Material Separation

  IT WAS REPORTED BY THE PHYSICIAN THAT A PATIENT WAS TREATED FOR A POSTERIOR CLOT IN THE VERTEBRAL ARTERY. LEFT RADIAL ACCESS WAS OBTAINED USING A ZOOM RDL ACCESS CATHETER. DURING THE FIRST PASS, THE ZOOM 71 WAS ADVANCED TO THE FACE OF THE CLOT IN THE V1 & V2 SEGMENT. ASPIRATION WAS APPLIED TO THE ZOOM 71 FOR APPROXIMATELY 2 MINUTES USING A ZOOM PUMP. WHILE RETRACTING THE ZOOM 71 THROUGH THE ZOOM RDL THE PHYSICIAN FELT RESISTANCE. THE PHYSICIAN ASSUMED THAT THE ZOOM RDL MIGHT HAVE KINKED, SO HE SLOWLY PULLED BACK THE ZOOM RDL TO STRAIGHTEN THE CATHETER. HE SUCCESSFULLY RETRACTED THE ZOOM 71 THROUGH THE ZOOM RDL. UPON REMOVAL, THE PHYSICIAN OBSERVED THAT THE ZOOM 71 SHAFT HAD SEPARATED AND WAS HELD TOGETHER BY A NITINOL COIL. A REPLACEMENT ZOOM 71 WAS ADVANCED THROUGH THE SAME ZOOM RDL TO CONTINUE WITH THE PROCEDURE. A SECOND PASS WAS PERFORMED, AND THE CLOT WAS SUCCESSFULLY REMOVED. THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE. THE PATIENT WAS REPORTED TO BE STABLE WITHOUT ANY PATIENT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569607 ↗
• InjuryOct 23, 2024Break; Material Separation; Stretched; Break; Material Separation; Stretched

  A 71-YEAR-OLD MALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT PROXIMAL M2 SEGMENT. ACCESS WAS OBTAINED USING A ZOOM 88 SUPPORT CATHETER THROUGH A SHORT 8F SHEATH TO THE PROXIMAL PETROUS TURN. THE PHYSICIAN STEAM SHAPED THE TIP OF A ZOOM 71 ASPIRATION CATHETER BEFORE ADVANCING IT THROUGH THE ZOOM 88 SUPPORT WITHOUT A GUIDEWIRE OR MICROCATHETER TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED WITH A 60CC VAC-LOCK SYRINGE FOR APPROXIMATELY 60 SECONDS. WHILE RETRACTING THE ZOOM 71 THROUGH THE ZOOM 88 SUPPORT, THE PHYSICIAN INDICATED IT FELT "VERY SMOOTH" WITH NO RESISTANCE NOTED. AS THE PHYSICIAN CONTINUED TO RETRACT THE ZOOM 71 THROUGH THE ZOOM 88 SUPPORT, HE NOTED THAT THE DISTAL END OF THE ZOOM 71 WAS NOT RETRACTING. IMAGING REVEALED THAT APPROXIMATELY 15-20 CM OF THE DISTAL END OF THE ZOOM 71 CATHETER WAS STILL IN THE PATIENT'S MIDDLE CEREBRAL ARTERY (MCA), WITH THE TIP TERMINATING AT THE PROXIMAL M2 SEGMENT. THE ZOOM 71 SEPARATED AT THE PROXIMAL END OF THE ZOOM 88 SUPPORT AND WAS HELD TOGETHER BY THE COIL. THE SEPARATED ZOOM 71 SEGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A THIRD PARTY MICROCATHETER AND SNARE DEVICE. THE CLOT IN THE M2 SEGMENT WAS REMOVED AND THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518216 ↗
• MalfunctionSep 12, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED BY THE TREATING PHYSICIAN THAT A ZOOM 71 CATHETER BROKE DURING A THROMBECTOMY PROCEDURE. A PATIENT WAS TREATED FOR AN OCCLUSION AT THE TERMINUS. ACCESS WAS OBTAINED WITH A THIRD-PARTY ACCESS CATHETER OVER A GUIDEWIRE. A ZOOM 71 CATHETER AND A THIRD-PARTY MICROCATHETER WERE ADVANCED OVER THE GUIDEWIRE THROUGH THE ACCESS CATHETER TO THE FACE OF THE CLOT. ASPIRATION WAS THEN APPLIED. WHILE RETRACTING THE ZOOM 71, THE PHYSICIAN FELT RESISTANCE. FLUOROSCOPY SHOWED THAT AT THE COMMON CAROTID ARTERY, THE ZOOM 71 CATHETER HAD BENT ON ITSELF AT THE BIFURCATION OF THE INTERNAL AND EXTERNAL CAROTID ARTERIES. THE PHYSICIAN ATTEMPTED TO RETRACT THE ZOOM 71 BUT WAS UNSUCCESSFUL. THE PHYSICIAN REMOVED THE ACCESS CATHETER, GUIDEWIRE, MICROCATHETER AND ZOOM 71 TOGETHER AS A SYSTEM FROM THE PATIENT. ONCE REMOVED, THE PHYSICIAN FOUND THAT THE END OF THE ZOOM 71 WAS "HOLDING ON BY A STRING TO THE REST OF THE CATHETER". A NEW REPLACEMENT ZOOM 71 WAS USED TO COMPLETE THE PROCEDURE AND THE CLOT WAS REMOVED SUCCESSFULLY. THE PATIENT ACHIEVED PARTIAL REPERFUSION WITH A TICI 2B SCORE. NO PATIENT SEQUELAE WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206618 ↗
• InjuryAug 26, 2024Break; Material Separation; Break; Material Separation

  AN 85-YEAR-OLD PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT MIDDLE CEREBRAL ARTERY (MCA). ACCESS WAS OBTAINED USING A ZOOM 88 ACCESS CATHETER, WHICH WAS ADVANCED TO THE HIGH CERVICAL. THE PHYSICIAN NOTED A KINK IN THE ACCESS CATHETER, DUE TO A 360-DEGREE LOOP AT THE ILIAC. THE PHYSICIAN STRAIGHTENED OUT THE KINK. DURING THE FIRST PASS, A ZOOM 71 ASPIRATION CATHETER WAS ADVANCED THROUGH THE ZOOM 88 TO THE CLOT IN THE LEFT MCA. THE PHYSICIAN CONFIRMED THERE WAS NO RESISTANCE WHILE ADVANCING THE CATHETER. AFTER THE ZOOM 71 CORKED THE CLOT, ASPIRATION WAS APPLIED, AND THE CLOT WAS REMOVED AFTER THE FIRST PASS. THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE. WHILE RETRACTING THE ZOOM 71 THROUGH THE ZOOM 88, RESISTANCE WAS NOTED. THE PHYSICIAN INDICATED THE ARCH WAS "CHALLENGING" AND THE PATIENT HAD A TORTUOUS ANATOMY. IMAGING SHOWED THAT THE ZOOM 71 HAD SEPARATED APPROXIMATELY 10-12 CM FROM THE DISTAL PORTION OF THE CATHETER IN THE INTERNAL CAROTID ARTERY AND DRIFTED INTO THE LEFT M1 SEGMENT. A MICROCATHETER AND STENT RETRIEVER WERE ADVANCED THROUGH THE ZOOM 88 TO THE BROKEN ZOOM 71 SEGMENT. THE STENT RETRIEVER SUCCESSFULLY CAPTURED THE ZOOM 71 SEGMENT AND WAS RETRACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070918 ↗
• DeathJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 67-YEAR-OLD MALE PATIENT WAS BEING TREATED FOR AN OCCLUSION AT THE LEFT M1 SEGMENT. A ZOOM 88 ACCESS CATHETER AND A THIRD-PARTY INSERT CATHETER WERE INTRODUCED INTO THE LEFT COMMON CAROTID ARTERY (CCA) AS A SYSTEM. A ROADMAP ANGIOGRAM WAS COMPLETED OF THE CCA TO VISUALIZE THE CAROTID BIFURCATION. A DIAGNOSTIC CATHETER WAS USED TO SELECT THE INTERNAL CAROTID ARTERY (ICA) OVER A GLIDEWIRE. THE ZOOM 88 WAS THEN ADVANCED AND PARKED AT THE ICA CAVERNOUS. DURING THE FIRST AND SECOND PASSES, A THIRD-PARTY MICROCATHETER AND MICROWIRE WERE ADVANCED THROUGH A ZOOM 71 ASPIRATION CATHETER AS A SYSTEM INTO THE ZOOM 88. THE ZOOM 71 WAS ADVANCED TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED. THE ZOOM 71 CATHETER WAS REMOVED UNDER CONTINUOUS ASPIRATION FROM THE PATIENT. A CONTRAST RUN SHOWED THE THROMBUS WAS NOT ASPIRATED. DURING THE THIRD PASS, A DIFFERENT THIRD-PARTY MICROCATHETER AND MICROWIRE WERE ADVANCED THROUGH THE ZOOM 88 PAST THE M1 OCCLUSION. THE MICROWIRE WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH A STENT RETRIEVER. THE STENT RETRIEVER WAS ADVANCED AND ALLOWED TO SET IN THE CLOT FOR 5 MINUTES. THE STENT RETRIEVER WAS REMOVED; HOWEVER, THE THROMBUS WAS NOT CAPTURED WITHI

  Patient problems: Stroke/CVA

  MAUDE report 19779103 ↗
• MalfunctionJul 18, 2024Break; Material Separation; Break; Material Separation

  AN 83-YEAR-OLD MALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT MIDDLE CEREBRAL ARTERY (MCA). ACCESS WAS OBTAINED USING A ZOOM 88 ACCESS CATHETER, WHICH WAS ADVANCED TO THE MID CERVICAL. DURING THE FIRST PASS, A ZOOM 71 ASPIRATION CATHETER WAS ADVANCED THROUGH ZOOM 88 TO THE CLOT IN THE LEFT MCA. ASPIRATION WAS THEN APPLIED TO THE ZOOM 71. THE ZOOM 71 WAS RETRACTED INTO ZOOM 88 AND RESISTANCE WAS NOTED WHEN THE TIP OF ZOOM 71 REACHED THE TIP OF ZOOM 88. THE TREATING PHYSICIAN CONTINUED REMOVAL OF THE ZOOM 71 THROUGH THE ZOOM 88. AFTER THE ZOOM 71 REMOVAL, IT WAS NOTED THAT THE RADIOPAQUE MARKER BAND WAS MISSING. IMAGING WAS CONDUCTED AND SHOWED THE ZOOM 71 MARKER BAND REMAINING IN THE PATIENT. THE PHYSICIAN DETERMINED THAT THE MARKER BAND WAS NON-FLOW LIMITING AND DECIDED TO NOT ATTEMPT REMOVAL. THE ZOOM 88 WAS REMOVED FROM THE PATIENT. NO DEVICE DEFICIENCY WAS OBSERVED ON THE ZOOM 88. A NEW CATHETER SYSTEM CONSISTING OF A THIRD-PARTY GUIDE CATHETER, A THIRD-PARTY ASPIRATION CATHETER, AND A ZOOM 35 WAS USED TO COMPLETE THE PROCEDURE. THE CLOT WAS REMOVED WITH THE ZOOM 35 CATHETER. THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE AND IS REPORTED TO BE STABLE. THERE

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 19778657 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS TREATED FOR AN OCCLUSION IN THE RIGHT M1 SEGMENT. CT SCAN REVEALED AN EXTREMELY DENSE AND CALCIFIED CLOT. A THIRD-PARTY INSERT CATHETER AND ZOOM 88 ACCESS CATHETER WERE INTRODUCED OVER A GLIDEWIRE AND THE SYSTEM WAS ADVANCED OVER THE AORTIC ARCH AND INTO THE CERVICAL REGION. THE THIRD-PARTY INSERT CATHETER WAS THEN REMOVED. A ZOOM 71 ASPIRATION CATHETER WAS NAVIGATED OVER A THIRD-PARTY MICROCATHETER AND MICROWIRE THROUGH THE ZOOM 88. THE ZOOM 71 ASPIRATION CATHETER WAS ADVANCED INTO THE M1 SEGMENT TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED TO THE ZOOM 71. AFTER THREE PASSES, NO MEANINGFUL REPERFUSION WAS ACHIEVED. DURING THE FOURTH PASS, THE PHYSICIAN ADVANCED THE SAME ZOOM 71 OVER THE SAME THIRD-PARTY MICROCATHETER AND MICROWIRE TO THE FACE OF THE CLOT. THE PHYSICIAN THEN CROSSED THE CLOT WITH THE THIRD-PARTY MICROCATHETER AND MICROWIRE, GOING OUT THE SUPERIOR TRUNK OF THE MIDDLE CEREBRAL ARTERY (MCA). THE MICROWIRE WAS REMOVED AND A STENT RETRIEVER WAS ADVANCED THROUGH THE MICROCATHETER. THE STENT RETRIEVER WAS DEPLOYED ALONG THE ENTIRE M1 SEGMENT. THE ZOOM 71 WAS THEN POSITIONED TO ENSURE IT WAS AT THE FACE OF THE CLOT, TRAPPING THE CLOT BETWEEN THE STENT RETR

  Patient problems: Perforation of Vessels

  MAUDE report 19745960 ↗
• InjuryMay 8, 2024Break; Material Separation; Break; Material Separation

  A PATIENT WAS TREATED FOR AN OCCLUSION AT THE RIGHT DISTAL M1 SEGMENT. ACCESS WAS OBTAINED USING A GUIDEWIRE, A ZOOM 88 ACCESS CATHETER, AND A THIRD-PARTY SELECT CATHETER. THE PHYSICIAN NOTED A TORTUOUS ARCH ANATOMY BUT NO STENOSIS OR CALCIFICATION. DURING THE FIRST PASS, THE ZOOM 88 WAS PARKED AT THE DISTAL CERVICAL. A ZOOM 71 CATHETER WAS THEN ADVANCED OVER THE SELECT CATHETER AND THROUGH THE ZOOM 88 TO THE FACE OF THE CLOT. AFTER REMOVING THE GUIDEWIRE AND THIRD-PARTY SELECT CATHETER, ASPIRATION WAS APPLIED TO THE ZOOM 71. THE ZOOM 71 WAS REMOVED WITHOUT ANY REPORTED ISSUE. POST CONTRAST RUN, AN ANGIOGRAM IMAGING SHOWED THE CLOT WAS NOT COMPLETELY REMOVED. FOR THE SECOND PASS, THE SAME ZOOM 71 WAS ADVANCED THROUGH THE ZOOM 88 AND ASPIRATION BEGAN. THE ZOOM 71 WAS REMOVED WITHOUT ANY RESISTANCE. AFTER THE CONTRAST RUN, IMAGING SHOWED THAT THE DISTAL PORTION (APPROXIMATELY 1 CM) OF THE ZOOM 71 CATHETER WAS SITTING IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE SEPARATED DISTAL CATHETER PORTION WITH AN 0.024" GUIDEWIRE, HOWEVER, WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO ADVANCE A SECOND ZOOM 71 THROUGH THE ZOOM 88 AND SUCCESSFULLY ASPIRATED THE SEPARATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272064 ↗
• MalfunctionMay 3, 2024Break; Material Separation; Break; Material Separation

  A PATIENT WAS TREATED FOR AN OCCLUSION IN THE LEFT PROXIMAL MIDDLE CEREBRAL ARTERY/M1 SEGMENT. ACCESS WAS OBTAINED WITH A GUIDEWIRE, A MICROCATHETER, AND A TRACSTAR ACCESS CATHETER TO THE LEFT COMMON CAROTID ARTERY (CCA). DURING THE FIRST PASS, THE GUIDEWIRE AND THE MICROCATHETER WERE REMOVED AND A 0.035" GUIDEWIRE AND A ZOOM 71 CATHETER WERE ADVANCED THROUGH THE TRACSTAR TO THE LEFT CCA. A ZOOM 35 CATHETER WAS THEN ADVANCED THROUGH THE ZOOM 71 AND DURING ADVANCEMENT THE PHYSICIAN FELT RESISTANCE IN THE LEFT CCA. THE PATIENT'S ANATOMY DID NOT EXHIBIT TORTUOSITY, STENOSIS, OR CALCIFICATION. THE PHYSICIAN PROCEEDED TO REMOVE THE GUIDEWIRE, THE ZOOM 35, AND THEN THE ZOOM 71 WITHOUT PERFORMING ASPIRATION. UPON REMOVAL, THE PHYSICIAN NOTED THAT APPROXIMATELY 10 CM PORTION OF THE ZOOM 71 CATHETER HAD SEPARATED INSIDE THE TRACSTAR. THE PHYSICIAN RETRACTED THE SEPARATED ZOOM 71 AND TRACSTAR AS A SYSTEM. AFTER THE REMOVAL OF THE ZOOM 71 AND TRACSTAR DEVICES, A KINK WAS NOTED ON THE TRACSTAR. PER THE PHYSICIAN, THE KINK WAS NOT OBSERVED DURING THE CASE. THE PHYSICIAN PROCEEDED WITH THE CASE USING A NEW TRACSTAR AND ZOOM 71. AFTER ASPIRATION, THE CLOT WAS SUCCESSFULLY REMOVED, AND THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239121 ↗
• MalfunctionApr 30, 2024Break; Material Separation; Break; Material Separation

  THE PATIENT FIRST UNDERWENT A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE TO ADDRESS A SUBDURAL HEMATOMA RESULTING FROM A FALL. RADIAL ACCESS WAS ACHIEVED USING A THIRD-PARTY ACCESS CATHETER AND MICROCATHETER FOR COIL DEPLOYMENT. FOLLOWING THE MMA EMBOLIZATION PROCEDURE, A MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED TO REMOVE THE OCCLUSION LOCATED AT THE RIGHT MID-MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT'S ANATOMY WAS TORTUOUS, AND STENOSIS WAS OBSERVED JUST DISTAL TO THE CAROTID BULB, BEFORE THE EXTERNAL CAROTID ARTERY (CA). DURING THE FIRST PASS, ACCESS WAS OBTAINED USING AN RDL, A 0.038" GLIDEWIRE, AND A THIRD-PARTY SELECT CATHETER. THE RDL WAS PARKED AT THE MID-EXTERNAL CA. A ZOOM 71 WAS ADVANCED TO THE FACE OF THE CLOT, AND AFTER REMOVING THE THIRD-PARTY SELECT CATHETER, ASPIRATION WAS APPLIED. WHILE RETRACTING THE ZOOM 71 THROUGH THE RDL RESISTANCE WAS FELT (LOCATION OF THE RESISTANCE WAS NOT SPECIFIED). THE TREATING PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE ZOOM 71 HAD STRETCHED PROXIMAL TO THE TIP. THE ENTIRE ZOOM 71 AND RDL WERE SUCCESSFULLY REMOVED TOGETHER AS A SYSTEM. THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE. POST PROCEDURE, THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217390 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE LEFT INFERIOR DIVISION M2 SEGMENT. ACCESS WAS OBTAINED WITH A ZOOM 88 GUIDE CATHETER OVER A GLIDEWIRE. THE ZOOM 88 WAS POSITIONED IN THE PROXIMAL CERVICAL INTERNAL CAROTID ARTERY (ICA) AND THE GLIDEWIRE WAS REMOVED. A GUIDEWIRE, THIRD-PARTY MICROCATHETER, AND A ZOOM 55 ASPIRATION CATHETER WERE ADVANCED TO THE FACE OF THE CLOT. THE MICROCATHETER AND GUIDEWIRE WERE THEN REMOVED, AND MANUAL ASPIRATION WAS APPLIED TO THE ZOOM 55. ANGIOGRAPHY WAS PERFORMED, AND NO SIGNIFICANT CHANGE WAS OBSERVED. DURING THE SECOND PASS, THE TREATING PHYSICIAN REMOVED THE ZOOM 55 AND ADVANCED A ZOOM 71 AND APPLIED MANUAL ASPIRATION USING THE SAME PROCESS AS IN THE FIRST PASS. ANGIOGRAPHY WAS REPEATED AND EVIDENCE OF STENOSIS/DISSECTION WAS OBSERVED IN THE SUPERIOR M2 SEGMENT, WHICH THE PHYSICIAN ATTRIBUTED TO CATHETER AGITATION. FOR THE THIRD PASS, THE ZOOM 71 WAS REMOVED, AND THE SAME ZOOM 55 WAS ADVANCED OVER THE SAME GUIDEWIRE. A NEW THIRD-PARTY MICROCATHETER AND A STENT RETRIEVER WERE THEN ADVANCED TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED TO THE ZOOM 55. ANGIOGRAPHY SHOWED THE OCCLUSION HAD WORSENED AND WAS NOW DO

  Patient problems: Vascular Dissection

  MAUDE report 19148551 ↗
• DeathMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE RIGHT M1 SEGMENT. ACCESS WAS OBTAINED WITH A THIRD-PARTY GUIDE CATHETER, THIRD-PARTY 5F CATHETER, AND A GUIDEWIRE. THE GUIDE CATHETER WAS POSITIONED AT THE HIGH CERVICAL OF THE INTERNAL CAROTID ARTERY (ICA) AND THE GUIDEWIRE WAS REMOVED. A MICROWIRE, THIRD-PARTY MICROCATHETER, AND ZOOM 71 ASPIRATION CATHETER, WERE ADVANCED TO THE CLOT, AND A STENT RETRIEVER WAS DEPLOYED USING A SOLUMBRA TECHNIQUE. DURING THE FIRST PASS, A PORTION OF THE CLOT WAS REMOVED. NO ISSUES WERE REPORTED DURING THE FIRST PASS. DURING THE SECOND PASS, THE SAME DEVICES AND SAME APPROACH WERE USED. THE MICROWIRE AND THIRD-PARTY MICROCATHETER WERE ADVANCED ACROSS THE CLOT. WHILE ADVANCING THE ZOOM 71 TO THE FACE OF THE CLOT THE PHYSICIAN REPORTED FEELING RESISTANCE. THE MICROWIRE WAS REMOVED AND A STENT RETRIEVER WAS DEPLOYED THROUGH THE THIRD-PARTY MICROCATHETER. THE THIRD-PARTY MICROCATHETER WAS REMOVED, AND THE STENT RETRIEVER WAS ALLOWED TO DWELL FOR 2-4 MINUTES. THE STENT RETRIEVER AND ZOOM 71 WERE WITHDRAWN WHILE ASPIRATION WAS APPLIED TO THE ZOOM 71. AFTER THE DEVICES WERE REMOVED, A CONTRAST RUN WAS PERFORMED THROUGH THE THI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 18907485 ↗
• MalfunctionFeb 16, 2024Break; Material Separation; Break; Material Separation

  DURING PREPARATION, A ZOOM 71 ASPIRATION CATHETER WAS FLUSHED WHILE STILL IN THE PACKAGING HOOP. A GUIDEWIRE AND THIRD-PARTY MICROCATHETER WERE HYDRATED OUTSIDE OF THE ZOOM 71. THE GUIDEWIRE AND THIRD-PARTY MICROCATHETER WERE THEN ADVANCED INTO THE ZOOM 71 WHILE THE ZOOM 71 REMAINED IN THE PACKAGING HOOP. THE TECHNICIAN PULLED THE CONSTRUCT OF THE ZOOM 71, THIRD-PARTY MICROCATHETER, AND GUIDEWIRE FROM THE ZOOM 71 PACKAGING HOOP. THERE WAS SLIGHT FRICTION EXPERIENCED WHEN REMOVING THE DEVICES AS A SYSTEM. UPON REMOVAL FROM THE PACKAGING HOOP, THE ZOOM 71 WAS FOUND TO BE SEPARATED. ANOTHER ZOOM 71 WAS PREPPED AND USED TO COMPLETE THE CASE WITHOUT ANY ISSUES. THE PATIENT IS REPORTED TO BE STABLE WITHOUT ANY SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727434 ↗