PROWLER SELECT 606-S255FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10886704028857), received between Nov 16, 2016 and Jul 17, 2025 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (17 reports).

2 other recalls cover devices cleared under the same FDA submission (K021591); they may or may not involve this specific model.

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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE ON (B)(6) 2025, THE 4.0MM X 30MM WITH NO TIP ENTERPRISE®2 (ENF403000 / 9320829) BECAME IMPEDED IN THE CONCOMITANT 150CM X5CM PROWLER SELECT PLUS / 45 TIP (606S255FX / 31471103) WHEN THE PHYSICIAN TRIED TO ADVANCE THE STENT IN THE MIDPOINT OF THE MICROCATHETER. THE DEVICES WERE REPLACED WITH ANOTHER 4.0MM X 30MM WITH NO TIP ENTERPRISE®2 (ENF403000) AND ANOTHER 150CM X5CM PROWLER SELECT PLUS / 45 TIP (606S255FX) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THE DEVICES WERE REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537923 ↗
• MalfunctionJul 10, 2023Crack; Crack

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE HUB OF A PROWLER SEL PLUS 150/5CM 45TIP MICROCATHETER (606S255FX, LOT UNKNOWN) WAS CRACKED. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287633 ↗
• MalfunctionMar 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, AT THE END OF THE PROCEDURE, A PROWLER SEL PLUS 150/5CM 45TIP MICROCATHETER (606S255FX, 30903904) SHOWED A GEL-LIKE SUBSTANCE AT THE PROXIMAL END OF THE HEMOSTATIC VALVE. THERE WAS NO PATIENT INJURY REPORTED. IN ORDER TO FURTHER INVESTIGATE THIS MATTER, THE CUSTOMER HAD THE PROWLER SELECT PLUS MICROCATHETER, THE ASSOCIATED HEMOSTATIC VALVES, AND A BRAND-NEW CATHETER EXAMINED IN A SUITABLE INSTITUTE. ADDITIONAL INFORMATION RECEIVED OF THE DEVICE INVOLVED CONCLUDED THE FOLLOWING: THE FT-IR SPECTRA OF THE DRYING RESIDUES OF THE CLOUDY APPEARING LIQUIDS AT THE END OF THE VALVE OF THE USED MICROCATHETER SHOW A SIGNIFICANT ACCORDANCE TO THE SPECTRUM OF THE OUTER SURFACE OF THE DISTAL END AS WELL AS THE ONE OF THE OUTER SURFACE OF THE LIGHT BLUE COLORED PART OF THE UNUSED CATHETER (P1). THE SPECTRA ALSO SHOW A SIGNIFICANT ACCORDANCE TO DATABASE SPECTRA OF POLYVINYLPYRROLIDONE. THE RESIDUES IN THE SAMPLE PROBABLY CONSIST OF POLYVINYLPYRROLIDONE. THE FT-IR SPECTRUM OF THE WHITISH PARTICLE IN THE LIQUID AT THE END OF THE VALVE OF THE SAMPLE SHOWS A VERY HIGH ACCORDANCE TO DATABASE SPECTRA OF DIFFERENT PROTEINS. THE PARTICLE IS VERY LIKELY FORMED BY PROTEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629067 ↗
• MalfunctionDec 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 4.0MM DIA X 23MM ENTERPRISE®2 STENT WITH NO TIP (ENF402300 / 11176793) BECAME STUCK IN THE PROXIMAL SECTION OF THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30465450) DURING THE ATTEMPT TO INSERT IT INTO THE MICROCATHETER THROUGH THE Y CONNECTOR. THE OPERATOR TRIED TO PULL THE ENTERPRISE STENT BUT DUE TO THE STRONG RESISTANCE, THE ENTERPRISE STENT COULD NOT BE REMOVED FROM THE MICROCATHETER. THERE WAS NO REPORT OF ANY PROCEDURE DELAY DUE TO THE REPORTED ISSUE; IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020463 ↗
• MalfunctionJul 30, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A BASILAR ARTERY (BA) TIP ANEURYSM, THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) WAS USED TO DELIVER THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (CATALOG / LOT# UNKNOWN) FOR IMPLANTATION, BUT THERE WAS RESISTANCE FELT AT THE DISTAL PART AND IT WAS DIFFICULT TO BE HANDLED. THE MICROCATHETER WAS REPLACED WITH A 45 TIP 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30545428) BUT THE RESISTANCE WAS WORSE THAN WITH THE FIRST MICROCATHETER; AND THE PULSERIDER BECAME STUCK. THE PRIMING WAS DONE WITHOUT ANY ISSUE. IT WAS REPORTED THAT THE PULSERIDER DEVICE WAS REPLACED WITH ANOTHER DEVICE AND THE PHYSICIAN USED THE FIRST MICROCATHETER (606S255X) WITH THE REPLACEMENT DEVICE TO COMPLETE THE PROCEDURE. DURING THE SAME PROCEDURE, THE 6MM X 15CM GALAXY G3 COIL (GLY120615 / 30401372) WAS USED AS THE FRAMING COIL, BUT IT DID NOT FIT THE LESION. THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) KICKED BACK, THEREFORE, THE COIL HAD TO BE RESHEATHED BUT IT COULD NOT BE RESHEATHED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256995 ↗
• MalfunctionJun 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0MM DIA X 30MM WITH NO TIP ENTERPRISE®2 STENT (ENF403000 / 11089436) WAS IMPEDED IN THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30333005). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926033 ↗
• MalfunctionFeb 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, DURING THE ATTEMPT TO ADVANCE A COMPETITOR STENT RETRIEVER, THE GUIDEWIRE WAS NOT ABLE TO BE ADVANCED THROUGH THE 150CM X15CM, 45-DEGREE PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30039161) RESULTING IN A LOSS OF CEREBRAL TARGET POSITION. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE CEREBRAL TARGET VESSEL IS NOT KNOWN. IT WAS REPORTED THAT THE ISSUE OCCURRED IN THE MIDDLE PART OF THE MICROCATHETER. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. EXCESSIVE FORCE WAS NOT APPLIED AND THE PROWLER SELECT PLUS MICROCATHETER DID NOT APPEAR DAMAGE BEFORE USE AND AFTER IT WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS REPLACED WITH ANOTHER PROWLER MICROCATHETER. IT WAS REPORTED THAT THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS USED FOR ANOTHER NAVIGATION DURING THE SAME PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388990 ↗
• MalfunctionFeb 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, DURING THE ATTEMPT TO ADVANCE A COMPETITOR STENT RETRIEVER, THE GUIDEWIRE WAS NOT ABLE TO BE ADVANCED THROUGH THE 150CM X15CM, 45-DEGREE PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30299292) RESULTING IN A LOSS OF CEREBRAL TARGET POSITION. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE CEREBRAL TARGET VESSEL IS NOT KNOWN. THE REPORTED ISSUE OCCURRED IN THE MIDDLE PART OF THE MICROCATHETER. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. EXCESSIVE FORCE WAS NOT APPLIED AND THE PROWLER SELECT PLUS MICROCATHETER DID NOT APPEAR DAMAGE BEFORE USE AND AFTER IT WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS REPLACED WITH ANOTHER PROWLER MICROCATHETER. IT WAS REPORTED THAT THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS USED FOR ANOTHER NAVIGATION DURING THE SAME PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388872 ↗
• MalfunctionFeb 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, DURING THE ATTEMPT TO ADVANCE A COMPETITOR STENT RETRIEVER, THERE WAS RESISTANCE THROUGH THE MIDDLE PART OF THE LUMEN OF THE 150CM X15CM, 45-DEGREE PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30299292) RESULTING IN A LOSS OF CEREBRAL TARGET POSITION. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE CEREBRAL TARGET VESSEL IS NOT KNOWN. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. EXCESSIVE FORCE WAS NOT APPLIED AND THE PROWLER SELECT PLUS MICROCATHETER DID NOT APPEAR DAMAGE BEFORE USE AND AFTER IT WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS REPLACED WITH ANOTHER PROWLER MICROCATHETER. IT WAS REPORTED THAT THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS USED FOR ANOTHER NAVIGATION DURING THE SAME PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388865 ↗
• MalfunctionNov 11, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  AS REPORTED BY THE FIELD, DURING AN EMERGENCY CASE, A PROWLER SELECT PLUS 150/5CM 45TIP MICROCATHETER (606S255FX, 30276585) WAS INSERTED INTO A 5FR SHEPHERD HOOK GUIDING CATHETER AND THE POWER SELECT PLUS WAS ATTEMPTED TO BE DELIVERED TO THE LESION. HOWEVER, THERE WAS AN INTENSIVE RESISTANCE FELT BETWEEN THE COMPLAINT MICROCATHETER (MC) AND THE GUIDING CATHETER. THE PHYSICIAN TRIED TO WITHDRAW THE COMPLAINT MC BUT IT BECAME SEPARATED. THE SEPARATED FRAGMENTS REMAINED INSIDE THE GUIDING CATHETER. ALL OF THEM WERE REMOVED BY REMOVING THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER MICROCATHETER AND GUIDING CATHETER. THERE WAS, ¿A SOMETHING BIG CATCH,¿ AND THE COMPLAINT MICROCATHETER WAS TORN OFF WHEN IT WAS PULLED OUT. THE COMPATIBILITY WAS PROPER. A 4MM X 12CM GALAXY G3 COIL (GLY120412, L16980) WAS INSERTED INTO THE COMPLAINT MICROCATHETER AS PER THE INSTRUCTIONS FOR USE (IFU), HOWEVER, THE PHYSICIAN FELT A SENSE OF DISCOMFORT THAT THE FORCE WAS NOT TRANSMITTED WELL. WHEN HE STOPPED SENDING, AND LOOKED CLOSELY AT THE WIRE, HE A KINKING PART. AFTER THAT, THERE WAS A FEELING THAT THE FORCE ESCAPED WHEN A 4MM X 15CM DELTAFILL18 COIL (DLF180415, 30412474) WAS DELIVERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823422 ↗
• InjuryJun 17, 2020Fracture; Fracture

  THE HEALTHCARE PROFESSIONAL REPORTED WHEN THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30286010) WAS FIRST OPENED, A KINK WAS NOTICED ON THE DEVICE AT 11CM FROM THE HUB OR TIP. THE DEVICE WAS NOT USED FOR THE PROCEDURE; THE PHYSICIAN USED ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE PRODUCT WAS RETURNED FOR EVALUATION; DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THERE WERE MULTIPLE COMPRESSED SECTIONS ON ONE AREA OF THE MICROCATHETER BODY. THE DISTAL TIP OF THE DEVICE WAS OBSERVED TO HAVE BEEN CUT FROM THE DEVICE. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 6/16/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165777 ↗
• MalfunctionJun 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, A 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX, 30299292) WAS DELIVERED TO THE LESION. THEN A 4MMX23MM ENTERPRISE2 STENT DELIVERY SYSTEM (ENC402300, 11157431) WAS INSERTED INTO THE MICROCATHETER (MC) BUT THERE WAS A STRONG RESISTANCE FELT AND IT WAS NOT ABLE TO ADVANCE THROUGH THE MC. THE STENT OF THE ENTERPRISE2 DID NOT DEPLOY INSIDE THE PATIENT. THEY WERE REPLACED WITH ANOTHER PROWLER SELECT PLUS AND ENTERPRISE 2. THE ENTERPRISE 2 WAS IMPLANTED WITHOUT ANY PROBLEMS. THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. IT IS UNCLEAR WHICH PART OF THE MICROCATHETER THE RESISTANCE OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE COMPLAINT STENT WAS INSERTED INTO THE COMPLAINT MICROCATHETER TO IMPLANT THE COMPLAINT STENT. THE MICROCATHETER CAME OUT FROM THE LESION. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COMPLAINT STENT AS PER THE INSTRUCTIONS FOR USE (IFU) BUT IT WAS IMPLANTED INSIDE THE COMPLAINT MICROCATHETER AND THE STENT WAS NOT ABLE TO BE RE-SHEATHED. THE PHYSICIAN REQUESTED THE INVESTIGATION OF THE DISTAL DELIVERY WIRE WHICH HAD STENT PART. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PICTURES W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157587 ↗
• MalfunctionJun 15, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, A 4MMX23MM ENTERPRISE2 STENT DELIVERY SYSTEM (ENC402300, 11004261) WAS INSERTED INTO A 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX, 17745485) BUT THERE WAS A STRONG RESISTANCE FELT AND IT WAS NOT ABLE TO ADVANCE THROUGH THE MICROCATHETER (MC). IT OCCURRED WHEN THE STENT WAS APPROXIMATE 3 CM FROM THE DISTAL END OF THE MC. THE STENT DID NOT DEPLOY INSIDE THE PATIENT. THE DEVICES WERE REPLACED WITH ANOTHER PROWLER SELECT PLUS AND ENTERPRISE 2. THE ENTERPRISE 2 WAS IMPLANTED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153291 ↗
• MalfunctionApr 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A 4MMX23MM ENTERPRISE2 NO TIP STENT DELIVERY SYSTEM (ENC402300,10998144), WAS INSERTED INTO A CONCOMITANT MICROCATHETER, 150/5CM 45TIP PROWLER SEL PLUS (606S255FX, 30296214) BUT THERE WAS INTENSIVE RESISTANCE FELT AT 5CM FROM THE DISTAL TIP. IT WAS NOT ABLE TO BE ADVANCED ANYMORE. IT WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PRE-SHIPMENT PICTURES OF THE PROWLER SELECT PLUS MICROCATHETER WERE RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978349 ↗
• MalfunctionMar 18, 2020Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE TIP OF A PROWLER SEL PLUS 150/5CM 45TIP (606S255FX, 30061145) CRACKED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847559 ↗
• MalfunctionMar 10, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30296215) WAS DELIVERED TO THE INTERNAL CAROTID ARTERY TIP, THE 0.012-INCH GLIDEWIRE® GT GUIDEWIRE (TERUMO) WAS USED WITHOUT ANY ISSUE. THEN THE 4.0MM X 23MM ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (ENC402300 / 11157431) WAS ADVANCED AND AN ATTEMPT TO DEPLOY THE STENT WAS MADE, BUT THERE WAS STRONG RESISTANCE WHEN THE STENT WAS AT APPROXIMATELY 5 CM FROM THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN MADE SEVERAL ATTEMPTS, BUT THE ISSUE WAS NOT RESOLVED. ANOTHER 4.0MM X 23MM ENTERPRISE® 2 STENT FROM THE SAME LOT WAS USED BUT THE ISSUE WAS NOT RESOLVED. THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER AND THE REPLACEMENT STENT WAS DELIVERED AND IMPLANTED AT THE TARGET SITE WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9813317 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT FROM THE FIELD INDICATED THAT A VASOSPASM OCCURRED DURING USE OF A PROWLER SELECT PLUS 150/5CM 45TIP (606S255FX/UNKNOWN LOT #) MICROCATHETER IN AN ENDOVASCULAR COIL EMBOLIZATION OF THE RIGHT INTERNAL MAMMARY ARTERY. THE PHYSICIAN ABORTED THE DELIVERY OF THE PROWLER SELECT PLUS MICROCATHETER, AND THE UNSPECIFIED COIL WAS ATTEMPTED TO BE DELIVERED TO ANOTHER BLOOD VESSEL. HOWEVER, THERE WAS A STRONG RESISTANCE FELT BETWEEN THE PROWLER SELECT PLUS MICROCATHETER AND THE COIL. THE MICROCATHETER AND CONCOMITANT COIL WERE REMOVED FROM THE PATIENT AS A UNIT AND INSPECTED, BUT NO VISUAL ANOMALIES WERE NOTED. THE PROWLER SELECT PLUS MICROCATHETER WAS SUBSEQUENTLY REPLACED WITH ANOTHER PROWLER SELECT PLUS MICROCATHETER. THE CASE WAS CONCLUDED WITH THE EMBOLIZATION OF FOUR BLOOD VESSELS WITH 24 COILS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Vasoconstriction

  MAUDE report 9780125 ↗
• MalfunctionDec 23, 2019Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30248169) WAS ADVANCED TOWARD THE M1 SEGMENT TO IMPLANT A 4.0MM X 16MM ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (ENC401600 / 11004256), THE ENTERPRISE STENT WAS INSERTED IN THE MICROCATHETER BUT STRONG RESISTANCE WAS FELT BEFORE THE ENTERPRISE STENT EXITED THE MICROCATHETER; THE STENT WAS NOT ABLE TO ADVANCE. THE PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER FROM A DIFFERENT LOT (30239459); WITH THIS REPLACEMENT MICROCATHETER, THE ENTERPRISE STENT ALSO EXPERIENCED STRONG RESISTANCE, BUT THE PHYSICIAN WAS ABLE TO DELIVER, DEPLOY AND IMPLANT THE ENTERPRISE STENT AT THE INTENDED LOCATION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511837 ↗
• MalfunctionNov 1, 2019Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A MENINGIOMA AT THE MIDDLE MENINGEAL ARTERY, THERE WAS RESISTANCE BETWEEN THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30086380) AND THE CONCOMITANT 0.014-INCH GUIDEWIRE. THE MICROCATHETER WAS REPLACED WITH THE EXCELSIOR® 1018® MICROCATHETER (STRYKER) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION DUE TO SUSPICION OF INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267020 ↗
• MalfunctionOct 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 150CM X5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / LOT: UNK) WAS REMOVED BECAUSE THE 4MM DIA X 16MM ENTERPRISE®2 STENT (ENF402300 / LOT: UNK) WAS STUCK INSIDE OF IT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142704 ↗
• MalfunctionJun 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY AN AFFILIATE, DURING AN ISCHEMIC STROKE CASE, AN EMBOTRAP STENT RETRIEVER ¿JAMMED¿ INTO A PROWLER SELECT PLUS 45 TIP MICROCATHETER (606S255FX, 30092209). THE USER WAS NOT ABLE TO PUSH OR PULL THE PRODUCT OUT SO FINALLY THEY PULLED OUT THE PROWLER SELECT PLUS MICROCATHETER. THE SAME EMBOTRAP AND A NEW MICROCATHETER (PROWLER SELECT PLUS) WAS USED AND THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A TEN MINUTES DELAY. THE PHYSICIAN DOES NOT FEEL THE PROLONGATION OF PROCEDURE WAS CLINICALLY SIGNIFICANT. NO PATIENT CONSEQUENCE AND THE PATIENT IS STABLE AT HOME. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS INSPECTED FOR DAMAGE PRIOR TO USE AND THERE WAS NO DAMAGE NOTED. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THE RESISTANCE WAS FELT AT THE DISTAL TIP OF THE CATHETER. THEY WERE NOT ABLE TO TORQUE THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738849 ↗
• MalfunctionApr 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED INTERNAL CAROTID ARTERY ANEURYSM, THE 4MM X 23MM ENTERPRISE2 (ENC402300/11017350) STENT VASCULAR RECONSTRUCTION DEVICE WAS INSERTED INTO THE PROWLER SELECT PLUS 150/5CM (606S255FX/30107060) MICROCATHETER, BUT THERE WAS STRONG RESISTANCE FELT BETWEEN THE STENT AND MICROCATHETER AT THE CAROTID SIPHON AND THE STENT COULD NO LONGER BE ADVANCED. THEREFORE, THE DEVICES WERE REMOVED AND REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DEPLOYMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE DEVICES WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511131 ↗
• MalfunctionOct 5, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY FOR AN ACUTE ISCHEMIC STROKE, THE 5 X 21 EMBOTRAP II (ET007521/17K078AV) WAS UNABLE TO BE WITHDRAWN INTO THE 6F 0.070¿ ID SOFIA INTERMEDIATE CATHETER. THE THROMBOTIC OCCLUSION WAS 6 TO 8MM IN LENGTH AND LOCATED IN THE MIDDLE CEREBRAL ARTERY (DISTAL M1 TO M2). THE PATIENT WAS VERY TALL AND THE ACCESS WAS VERY DIFFICULT, ESPECIALLY TO GET THE SOFIA ALONG THE OPHTHALMIC ARTERY. A PROWLER SELECT PLUS 0.021¿ MICROCATHETER (606S255FX/17738046) AND PENUMBRA NEURON MAXX 80CM GUIDE CATHETER WERE ALSO USED FOR THE PROCEDURE. THE PHYSICIAN REACHED THE OCCLUSION WITH THE SOFIA PROXIMAL TO THE THROMBUS AND POSITIONED THE EMBOTRAP II. IT TOOK A LOT OF PRESSURE TO GET THE EMBOTRAP II WITHDRAWN INTO THE 6F SOFIA CATHETER. A LOT OF THROMBUS WAS RETRIEVED, BUT THE ARTERY WAS STILL NOT REVASCULARIZED. THEY POSITIONED THE EMBOTRAP II AGAIN WITH THE SAME 6F SOFIA BUT FELT EVEN MORE FRICTION. FOR THE THIRD PASS THEY TOOK A NEW 6F SOFIA, A NEW PROWLER SELECT PLUS MICROCATHETER (606S255X/30023649) , BUT THE SAME EMBOTRAP II. WHEN THEY TRIED TO WITHDRAW THE EMBOTRAP II, THE FRICTION WAS SO HIGH THAT THE PROXIMAL PART OF THE 6F SOFIA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7938452 ↗
• MalfunctionOct 2, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM, THE PROWLER SELECT PLUS 150/5CM 45 TIP (606-S255FX/30026752) MICROCATHETER WAS DELIVERED TO THE TARGET LESION AND THE 4MM X 23MM ENTERPRISE 2 NO TIP (ENC402300/10978028) STENT WAS ATTEMPTED TO BE PLACED BUT THE STENT PARTIALLY DEPLOYED OUT THE MICROCATHETER AND COULD NOT BE FULLY RELEASED/DELIVERED. THE USER TRIED TO DEPLOY THE STENT BY PULLING THE CATHETER TO SOME EXTENT, BUT IT COULD NOT BE DEPLOYED. THE PROWLER SELECT PLUS MICROCATHETER AND ENTERPRISE 2 STENT WERE REMOVED FROM THE PATIENT VASCULATURE AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE REPLACEMENT ENTERPRISE 2 STENT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER DEPLOYMENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE/DEFECT WAS NOTED PRIOR TO THE EVENT. THE PRODUCTS WERE PREPPED AND USED ACCORDING TO THE IFU. THE MICROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926575 ↗
• MalfunctionJul 24, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTERIOR CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM, AN 4X12 ORBIT GALAXY TDL COMPLEX FILL (640CF0412/(B)(4)) HYDRAULIC COIL WAS INSERTED INTO THE PROWLER SELECT PLUS 150/5CM 45TIP (606-S255FX/(B)(4)) MICROCATHETER BUT STRONG RESISTANCE WAS ENCOUNTERED AND THE COIL DELIVERY SYSTEM COULD NEITHER BE ADVANCED NOR WITHDRAWN. THE COIL DID NOT EXIT THE TIP OF THE MICROCATHETER, SO THE COIL WAS REMOVED AS A UNIT WITH THE MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH A COMPETITOR PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. THE PRODUCTS WERE DISCARDED AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021591. One submission often covers many models, so check the product and lot details in each record.

• Z-1482-06 · Aug 11, 2006 · Terminated
  Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
• Z-1483-06 · Aug 11, 2006 · Terminated
  Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.