PROWLERRecalls & reported problems across all models

We found 8 models of PROWLER by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2017 and May 26, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PROWLER problems

PROWLER models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PROWLER 606-151X

  Catheter, continuous flush
  8 reports
• PROWLER 606-151FX

  Catheter, continuous flush
  7 reports
• PROWLER 606-171

  Catheter, continuous flush
  2 reports
• PROWLER 606-051FX

  Catheter, continuous flush
  1 report
• PROWLER 606-051X

  Catheter, continuous flush
  1 report
• PROWLER 606-151JX

  Catheter, continuous flush
  1 report
• PROWLER 606-2510

  Catheter, continuous flush
  1 report
• PROWLER 606-2510X

  Catheter, continuous flush
  1 report

Recent PROWLER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FLUSHED THE 10CM X 150CM DUAL MARKERS PROWLER 10 (606051X / 31700155) WITH SALINE AND OBSERVED THAT FLUID ESCAPED FROM THE SITE NEAR THE MICROCATHETER HUB. THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT¿S BODY AND REPLACED IT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 22-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A MIDDLE CEREBRAL ARTERY ARTERIOVENOUS MALFORMATION. THE REPLACEMENT DEVICE WAS ANOTHER 10CM X 150CM DUAL MARKERS PROWLER 10 (606051X). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284663 ↗
• InjuryApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED, VIA A HEALTH AUTHORITY, THAT A PROWLER-14 170CM MICROCATHETER (606171/ 31512439) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE TIP OF THE MICROCATHETER BECAME STUCK TO THE VESSEL AFTER ADMINISTERING A LIQUID EMBOLIC AGENT TO THE TARGET SITE. WHEN ATTEMPTING TO WITHDRAW THE GLUED TIP FROM THE VESSEL, THE CATHETER STRETCHED AND SEPARATED. AS A RESULT, THE PHYSICIAN ¿TUCKED¿ THE RETAINED PORTION OF THE MICROCATHETER (APPROXIMATELY 3-4 INCHES IN LENGTH) INTO THE EXTERNAL CAROTID ARTERY AND PRECLUDE FURTHER COMPLICATIONS. THE EVENT WAS REPORTED AS SUCH, ¿DURING THE ANGIOGRAM, THE PHYSICIAN WAS ADMINISTERING GLUE (EMBOLIC FLUID) TO THE TARGET VESSEL AND REPORTED THAT HE GOT SOME FLUSH OF FLUID BACK TOWARDS THE CATHETER AND THE GLUE HIT THE TIP OF THE CATHETER AND STUCK TO IT. IN AN EFFORT TO WITHDRAW THE CATHETER FROM THE GLUE, THE CATHETER STRETCHED AND UNFORTUNATELY FRACTURED. WE DO NOT KNOW THE EXACT MEASUREMENT OF THE RETAINED CATHETER, BUT IT IS APPROXIMATELY 3-4 INCHES. THE REMAINDER OF THIS CATHETER WAS TUCKED INTO THE EXTERNAL CAROTID ARTERY (ECA) WHERE IT WILL NOT CAUSE ANY ISSUES GOING FORWARD PER MD AND NO FLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918750 ↗
• MalfunctionMar 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, BEFORE THE START OF THE PROCEDURE, THE PHYSICIAN INSPECTED THE PACKAGING OF THE 125CM LARGE BORE 71 CATHETER (IC71125UG / 31332260) AND OF THE ACTUAL LARGE BORE CATHETER. BOTH WERE IN GOOD CONDITION. AFTER THE PHYSICIAN SUCCESSIVELY DELIVERED A CEREBASE CATHETER (UNKNOWN CATALOG / LOT #), THE LARGE BORE CATHETER, AND THE PROWLER 14 DUAL MARKERS MICROCATHETER (606151X / 31178999) TO THE LESION SITE, THE COIL (UNSPECIFIED BRAND) WAS DETACHED IN THE TARGET SITE. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE DELIVERY WIRE OF THE COIL, THE DELIVERY WIRE WAS IMPEDED IN THE TIP OF THE PROWLER 14 MICROCATHETER TIP AND COULD NOT BE RETRACTED. THE PHYSICIAN REMOVED THE DELIVERY WIRE AND MICROCATHETER FROM THE PATIENT. IT WAS REPORTED THAT, ¿AT THIS TIME, THE PROXIMAL END (NOT IN THE PATIENT¿S BODY) OF THE LARGE BORE CATHETER WAS FOUND SLIGHTLY KINKED / BENT. THE PHYSICIAN ONLY REPLACED THE PROWLER 14 MICROCATHETER TO COMPLETE THE PROCEDURE, WHICH WAS PROLONGED BY APPROXIMATELY 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. ON (B)(6)2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654666 ↗
• MalfunctionAug 20, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED BY THE FIELD, DURING THE PREPPING OF A PROWLER-14 170CM MICROCATHETER (606171, 31083013), THE PHYSICIAN FELT THE CATHETER AND THE TIP FELT TEXTURED INSTEAD OF SMOOTH. THE CATHETER WAS NOT USED IN THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-AUG-2024 INDICATED THAT THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. IT WAS NOTED THAT THE REPORTED CONDITION MIGHT BE A RESULT OF A DELAMINATED OR CRACKED COATING. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO BREAK IN DEVICE INTEGRITY AT THE SITE OF THE DEFECT, LEADING TO POTENTIAL SEPARATION INTO TWO OR MORE SEPARATE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002098 ↗
• MalfunctionJun 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AN EMBOLIC COIL (UNSPECIFIED BRAND) WAS IMPEDED IN THE 150CM PROWLER14 DUAL MARKERS MICROCATHETER (606151X / 31130286) AND COULD NOT ADVANCE AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL FROM THE PATIENT AND SWITCHED TO A NEW MICROCATHETER TO COMPLETE THE PROCEDURE USING THE ORIGINAL EMBOLIC COIL. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 30-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE RIGHT INTERNAL CAROTID ARTERY / POSTERIOR COMMUNICATING ARTERY. THE VESSEL WAS ¿MORE TORTUOUS.¿ IT WAS INDICATED THAT RESISTANCE WAS FIRST FELT DURING THE RE-SHEATHING OF THE DEVICE FOR RE-USE; IT WAS FELT INSIDE THE MICROCATHETER AT THE DISTAL SECTION. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING ADVANCEMENT. THE INFORMATION INDICATED THAT THE MICROCATHETER WAS DAMAGED DURING DEVICE MANIPULATION, PUSHING THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590262 ↗
• MalfunctionOct 25, 2023Material Too Soft/Flexible; Physical Resistance/Sticking; Material Too Soft/Flexible; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE CERVICAL SEGMENT OF INTRACRANIAL ARTERY, A PROWLER-14 DUAL MARKER MICROCATHETER (606151X, 30802064) WAS PLACED IN TARGET SITE. THE PHYSICIAN DELIVERED AN UNSPECIFIED COIL INTO MICROCATHETER (MC) AND DETACHED THE COIL IN ANEURYSM. THE MICROCATHETER WAS FOUND TO BE MIGRATED INTO THE ANEURYSM. DOCTOR RETRACTED THE MICROCATHETER AND SWITCHED TO A NEW MICROCATHETER (OTHER BRAND) TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 07-OCT-2023 INDICATED THAT THERE WAS NO RESISTANCE FELT AT ANY POINT DURING PROCEDURE. THERE WAS NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS. THERE WAS NO DAMAGE TO THE MICROCATHETER DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003631 ↗
• MalfunctionMay 7, 2022Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE WITH THE TARGET LOCATED ON THE MIDDLE CEREBRAL ARTERY (MCA), WHEN THE 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30573303) WAS TAKEN OUT IN ORDER TO INTRODUCE THE GUIDEWIRE, IT WAS NOT POSSIBLE TO INTRODUCE THE GUIDEWIRE. THE MICROCATHETER WAS REMOVED AND A SMALL KINK WAS NOTED ON THE IT. A NEW MICROCATHETER WAS USED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14325221 ↗
• MalfunctionJan 12, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL COIL EMBOLIZATION, A CERENOVUS COIL WAS PLACED WITHOUT TROUBLE AND THEN A MICRUSFRAME14 7MMX11CM COIL (MFR140711, LOT UNKNOWN) WAS BEING USED AS THE SECOND COIL. HOWEVER, THE COIL COULD NOT BE ADVANCED WITHIN PRESHAPED PROWLER14 MICROCATHETER (606151FX, LOT UNKNOWN). THUS, THE COIL AND THE MC HAD TO BE WITHDRAWN. A NEW CERENOVUS COIL WAS USED WITH A NEW MC AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT APPEAR DAMAGED, IT COULD SIMPLY NOT BE PUSHED ANY FURTHER WITHIN THE MICROCATHETER. AFTER ADVANCEMENT WAS NOT POSSIBLE, WITHDRAWAL WAS TRIED BUT ALSO IMPOSSIBLE, THE COIL GOT STUCK. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235370 ↗
• MalfunctionJul 23, 2021Crack; Physical Resistance/Sticking; Crack; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE TARGETING A GIANT BASILAR ARTERY ANEURYSM, AFTER THE PHYSICIAN HAD ALREADY SUCCESSFULLY PLACED SEVEN (7) DIFFERENT COILS USING THE 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30289569), WHILE TRYING TO FINALIZE COILING USING THE 9MM X 25CM DELTAFILL 10 COIL (DLF100925 / 30395326), THERE WAS RESISTANCE ENCOUNTERED DURING THE ADVANCEMENT ATTEMPT. THE PHYSICIAN REMOVED THE COIL AND MADE ANOTHER ATTEMPT TO ADVANCE THE COIL THE SMALLER COIL, A 5MM X 15CM DELTAFILL 10 (DLF100515 / 30452192). THE SAME RESISTANCE WAS ENCOUNTERED AND IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE MICROCATHETER AND THE PHYSICIAN COULD NOT REMOVE THE COIL. HE DECIDED TO REMOVE THE COIL/MICROCATHETER SYSTEM OUT OF THE PATIENT; THE PHYSICIAN CHECKED THE DEVICE ON THE TABLE AND NOTED THAT THE PROWLER 14 MICROCATHETER HAS A HOLE IN IT; THERE WAS A VISIBLE KINK ON THE PROWLER 14 MICROCATHETER. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE 9MM X 25CM DELTAFILL 10 COIL THAT WAS REMOVED WAS NOT STRETCHED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO BLOOD FLOW REDUCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220352 ↗
• MalfunctionJul 29, 2020Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE COATING ON THE INSIDE OF THE PROWLER14 DUAL MARKER 150CM MICROCATHETER (606151X / LOT# UNKNOWN) FLAKED OFF AND AS A RESULT, THE COIL, A 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2535 / LOT# UNK) WAS NOT ABLE TO ADVANCE THROUGH THE MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT CONTINUOUS FLUSH HAD NOT BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER. IT WAS ALSO REPORTED THAT NONE OF THE COATING FLAKES ENTERED THE PATIENT. THE PHYSICIAN REPLACED THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED USING THE SAME COIL. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341255 ↗
• InjuryMay 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  A REPORT FROM THE FIELD INDICATED THAT SHORTLY BEFORE A 2X4 HYPERSOFT (MICROVENTION) COIL WAS COMPLETELY INSIDE THE ANEURYSM AND ABOUT TO BE DETACHED, THE COIL COULD NEITHER BE PUSHED NOR PULLED. THE PROWLER10 45TIP 2MRK (606051FX/17751954) PRE-SHAPED MICROCATHETER WAS ¿STRETCHED SO THE COIL TORN THROUGH¿. THE COIL WAS DAMAGED ¿AT THE JOINT BETWEEN THE COIL ITSELF AND THE PUSHER WIRE¿. PART OF THE COIL REMAINED IN THE CATHETER AND THE REST OF THE COIL IN THE PATIENT. THE ¿STRETCHED¿ COIL WAS ¿CATCHED¿ IN THE LONG SHEATH USING A STENT RETRIEVER. THERE WAS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT. A 3X10 HYPERSOFT (MICROVENTION) COIL WAS USED PRIOR TO THE COMPLAINT COIL AND THERE WERE NO ISSUES ENCOUNTERED DURING ADVANCEMENT OR DETACHMENT. THE MICROCATHETER HAD NOT BEEN RE-SHAPED AFTER REMOVAL FROM THE PACKAGING AND THE DEVICE HAD NOT BEEN INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTASIS VALVE. THE PHYSICIAN DID NOT HAVE ¿ANY PROBLEMS WHILE PROBING THE VESSELS WITH MICROWIRE AND MICROCATHETER¿. THE COMPLAINT MICROCATHETER AND PART OF THE 2X4 HYPERSOFT COIL WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 05-MAY-2020 INDICA

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 10028646 ↗
• MalfunctionOct 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY PROCEDURE, A 5X33 EMBOTRAP II STENT RETRIEVER (ET007533, 19G123AV) BECAME ¿STUCK¿ INTO THE 021 PROWLER SELECT MICROCATHETER (6062510, 30187162). THE DEVICE WAS NOT ABLE TO MOVE WITHIN THE MICROCATHETER. DUE TO THE RESISTANCE, THE MICROCATHETER WAS REMOVED AND THERE WAS LOSS OF CEREBRAL TARGET POSITION. THE DEVICES WERE FLUSHED WITHOUT DIFFICULTIES BEFORE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT NOR CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS COMPLETED BY THE PHYSICIAN USING ANOTHER SET OF DEVICES. THE EMBOTRAP NOR THE PROWLER SELECT APPEARED DAMAGED. THE INSERTION TOOL WAS SECURELY PLACED IN THE HUB OF THE MICROCATHETER PRIOR TO ATTEMPTING TO ADVANCE THE EMBOTRAP. THE TECHNIQUE USED TO HOLD THE INSERTION TOOL IN POSITION DURING ADVANCEMENT OF THE DEVICE WAS CORRECT. THE DEVICE WAS ABLE TO ADVANCE THROUGH THE HUB. ONE PASS HAD BEEN ATTEMPTED TO RETRIEVE THE CLOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249831 ↗
• MalfunctionSep 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A CEREBRAL EMBOLIZATION TO THE LEFT ANTERIOR COMMUNICATING ARTERY, A 2.5 MM X 3.3 CM MICRUSFRAME10 COIL (MFR100253, L14834), DID NOT ADVANCE THROUGH THE PROWLER 14 MICROCATHETER (MC) DURING DELIVERY. THE USER REMOVED BOTH THE COIL AND THE MICROCATHETER AND USED NEW PROWLER AND COIL. AFTER THE CHANGE OF THE DEVICES, THE USER WAS ABLE TO CONTINUE WITH THE EMBOLIZATION WITH NO PROBLEM. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A 20 MINUTES PROCEDURAL DELAY DUE TO THE EVENT. AFTER INSPECTION OF THE MICROCATHETER, IT LOOKS LIKE THE DISTAL PORTION WAS KINKED. NO EVIDENCE OF WHEN IT HAPPENED AND IF IT IS THE CAUSE OF THIS SITUATION. THE DEVICES WERE VISUALLY INSPECTED FOR DAMAGE PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH BEEN MAINTAINED THROUGH THE DEVICES. THE DEVICES DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. NO EXCESSIVE FORCE BEEN APPLIED TO THE DEVICES. THE RHV IS NOT A PROBLEM, IT WASN´T TOO TIGHT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A SECOND MICRUSFRAME10 COIL (UNKNOWN PRODUCT CODE/LOT) DID NOT ADVANCE THROUGH A SECOND PROWLER-14 DUAL MARKER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8993981 ↗
• MalfunctionJul 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A CEREBRAL EMBOLIZATION TO THE LEFT ANTERIOR COMMUNICATING ARTERY, A 2.5 MM X 3.3 CM MICRUSFRAME 10 COIL (MFR100253, L14834), DID NOT ADVANCE THROUGH THE PROWLER 14 MICROCATHETER (MC) DURING DELIVERY. THE USER REMOVED BOTH THE COIL AND THE MICROCATHETER AND USED NEW PROWLER AND COIL. AFTER THE CHANGE OF THE DEVICES, THE USER WAS ABLE TO CONTINUE WITH THE EMBOLIZATION WITH NO PROBLEM. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A 20 MINUTES PROCEDURAL DELAY DUE TO THE EVENT. AFTER INSPECTION OF THE MICROCATHETER, IT LOOKS LIKE THE DISTAL PORTION WAS KINKED. NO EVIDENCE OF WHEN IF HAPPENED AND IF IT IS THE CAUSE OF THIS SITUATION. THE DEVICES WERE VISUALLY INSPECTED FOR DAMAGE PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH BEEN MAINTAINED THROUGH THE DEVICES. THE DEVICES DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. NO EXCESSIVE FORCE BEEN APPLIED TO THE DEVICES. THE RHV IS NOT A PROBLEM, IT WASN´T TOO TIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773243 ↗
• MalfunctionApr 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE PHYSICIAN USED A NEVA¿ STENT RETRIEVER (VESALIO) AND MADE TWO ATTEMPTS TO DELIVER THE DEVICE THROUGH THE 150CM X 20CM DUAL MARKERS PROWLER PLUS MICROCATHETER (6062510X / 30003701), BUT THE DEVICE BECAME STUCK IN THE HUB OF THE PROWLER PLUS MICROCATHETER. THE NEVA¿ STENT RETRIEVER WAS REPLACED WITH AN EMBOTRAP REVASCULARIZATION DEVICE (CATALOG/LOT NUMBERS UNKNOWN) AND THE EMBOTRAP DEVICE WAS REPORTED TO BECOME STUCK IN THE SAME PLACE; IT COULD NOT CROSS THE DISTAL PART OF THE MICROCATHETER HUB. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATIONS. ADDITIONAL INFORMATION RELATED TO THE EVENT WAS REQUESTED AND WAS REPORTED TO BE UNAVAILABLE. THE PROWLER PLUS WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510509 ↗

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