AngioJet™ Solent™ Dista 111303-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729889731), received between Aug 28, 2018 and Sep 8, 2025 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (17 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. AN ANGIOJET SOLENT DISTA SOLENT DISTA CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BECAME KINKED AND A SALINE ERROR MESSAGE DISPLAYED. ANOTHER ANGIOJET SOLENT DISTA WAS SELECTED. CONSEQUENTLY, THE DEVICE STOPPED WORKING DUE TO AN ERROR MESSAGE. THE ANGIOJET CONSOLE WAS TURNED OFF AND BACK ON BUT THAT DID NOT RESOLVE THE CATHETER ERROR. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994903 ↗
• MalfunctionSep 8, 2025Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. AN ANGIOJET SOLENT DISTA SOLENT DISTA CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BECAME KINKED AND A SALINE ERROR MESSAGE DISPLAYED. ANOTHER ANGIOJET SOLENT DISTA WAS SELECTED. CONSEQUENTLY, THE DEVICE STOPPED WORKING DUE TO AN ERROR MESSAGE. THE ANGIOJET CONSOLE WAS TURNED OFF AND BACK ON BUT THAT DID NOT RESOLVE THE CATHETER ERROR. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994902 ↗
• MalfunctionDec 8, 2022Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL VESSEL. AN ANGIOJET SOLENT DISTA CATHETER WAS SELECTED FOR THROMBECTOMY PROCEDURE. THE DEVICE MADE TWO PASSES INTO THE VESSEL DURING THE PROCEDURE AND UPON REINSERTED, THE UNIT PROMPTED A CHECK SALINE ERROR MESSAGE WHEN TRYING TO ACTIVATE THE DEVICE. HEALTHCARE PERSONNEL (PHYSICIAN) DECIDED TO ABANDONED TREATMENT AND LYSIS THE PATIENT OVERNIGHT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946637 ↗
• MalfunctionJul 25, 2022Unexpected Shutdown; Unexpected Shutdown

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT SYSTEM UNEXPECTED SHUTDOWN OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS ADVANCED FOR A THROMBECTOMY PROCEDURE. HOWEVER; DURING THROMBECTOMY MODE, THE SYSTEM SHUTDOWN OR STOPPED ALL ACTIVITY. THE CATHETER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE CONTINUED NORMALLY. NO PATIENT COMPLICATIONS REPORTED. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED A BROKEN HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15098109 ↗
• MalfunctionJul 14, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER STUCK ON WIRE. AN ANGIOJET SOLENT DISTA CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PROCEDURE, THE CATHETER BECAME STUCK ON WIRE AND COULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD OR DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15017276 ↗
• MalfunctionMar 31, 2022Display or Visual Feedback Problem; Leak/Splash; Device Difficult to Setup or Prepare; Display or Visual Feedback Problem; Leak/Splash; Device Difficult to Setup or Prepare

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT CATHETER FAILED TO PRIME, PUMP ASSEMBLY LEAKED AND CHECK SALINE ERROR OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL POPLITEAL BYPASS ARTERY. AN ANGIOJET SOLENT DISTA WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER FAILED TO PRIME, THE PUMP ASSEMBLY LEAKED AND A CHECK SALINE SUPPLY ERROR MESSAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PLUGGED JET HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13958319 ↗
• MalfunctionMar 30, 2022Display or Visual Feedback Problem; Leak/Splash; Device Difficult to Setup or Prepare; Display or Visual Feedback Problem; Leak/Splash; Device Difficult to Setup or Prepare

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-MAR-2022. IT WAS REPORTED THAT CATHETER FAILED TO PRIME, PUMP ASSEMBLY LEAKED AND CHECK SALINE ERROR MESSAGE OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS ADVANCED FOR TREATMENT. DURING PREPARATION, THE CATHETER WOULD NOT COMPLETE THE PRIMING PROCESS. THE PHYSICIAN TRIED TO REBOOT THE CONSOLE AND RE-PRIME BUT STILL UNSUCCESSFUL. A LEAK AT THE PUMP ASSEMBLY WAS NOTICED AND CHECK SALINE ERROR MESSAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13951294 ↗
• MalfunctionMar 24, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS ON 02-MAR-2022. IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. AN ANGIOJET SOLENT DISTA WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT AN ERROR MESSAGE WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13897200 ↗
• MalfunctionNov 2, 2021Display or Visual Feedback Problem; Device Difficult to Setup or Prepare; Display or Visual Feedback Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET SOLENT DISTA WAS USED IN A THROMBECTOMY PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE SHOWED AN ERROR MESSAGE AND THE CATHETER WOULD NOT FLUSH. AS A RESULT, THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739647 ↗
• MalfunctionJun 1, 2021Display or Visual Feedback Problem; Pumping Problem; Display or Visual Feedback Problem; Pumping Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT ERROR MESSAGE AND PUMP SEAL FAULT OCCURRED. THE TARGET LESION WAS LOCATED IN A DISTAL VESSEL. TWO ANGIOJET SOLENT DISTA CATHETERS WERE USED IN A THROMBECTOMY PROCEDURE. HOWEVER DURING THE PROCEDURE, BOTH THE CATHETERS DISPLAYED CHECK SALINE SUPPLY ERROR MESSAGE WHEN SWITCHED TO POWER PULSE MODE AND THERE WERE BUBBLES NOTICED IN THE PUMP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917973 ↗
• MalfunctionJun 1, 2021Display or Visual Feedback Problem; Pumping Problem; Display or Visual Feedback Problem; Pumping Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT ERROR MESSAGE AND PUMP SEAL FAULT OCCURRED. THE TARGET LESION WAS LOCATED IN A DISTAL VESSEL. TWO ANGIOJET SOLENT DISTA CATHETERS WERE USED IN A THROMBECTOMY PROCEDURE. HOWEVER DURING THE PROCEDURE, BOTH THE CATHETERS DISPLAYED CHECK SALINE SUPPLY ERROR MESSAGE WHEN SWITCHED TO POWER PULSE MODE AND THERE WERE BUBBLES NOTICED IN THE PUMP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917961 ↗
• MalfunctionMay 28, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE DEVICE DID NOT TRACK WELL WHEN PUTTING OVER THE WIRE. THE PHYSICIAN ADVANCED THE DEVICE BUT HAD VERY LITTLE BLOOD RETURNED IN THE COLLECTION BAG AND IT WAS LIKELY AN ASPIRATION ISSUE. THE CONSOLE ALARMED INDICATING A KINK IN THE CATHETER. THE CONSOLE WAS RESET BUT THE ERROR STILL EXISTS. THE PHYSICIAN HAD DIFFICULTY PULLING THE CATHETER OFF THE WIRE SO BOTH DEVICES WERE PULLED OUT TOGETHER AND FOUND THAT THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH AN ANGIOJET SOLENT OMNI CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901670 ↗
• MalfunctionMay 24, 2021Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-MAY-2021. IT WAS REPORTED THAT CHECK SALINE SUPPLY ERROR AND CATHETER KINK OCCURRED. AN ANGIOJET SOLENT DISTA WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT CHECK SALINE SUPPLY ERROR OCCURRED AND A KINK TOWARD THE END OF THE DEVICE AND PLASTIC TUBING LOOKS MANGLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871261 ↗
• MalfunctionMay 19, 2021Suction Problem; Noise, Audible; Suction Problem; Noise, Audible

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS USED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WOULD MAKE AN ABNORMAL NOISE AND THERE WAS NOTHING COMING OUT OF THE SALINE BAG. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11851905 ↗
• MalfunctionMar 18, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN ANGIOJET SOLENT DISTA CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE WHILE IN THROMBECTOMY MODE, THE CATHETER DID NOT SUCTION. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517463 ↗
• MalfunctionSep 1, 2020Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS ADVANCED FOR A THROMBECTOMY PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT CATHETER COULD NOT DRAW FLUIDS BUT TUBING LOOKED GOOD WITH NO KINKS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477878 ↗
• MalfunctionAug 12, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET SOLENT DISTA CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING PRIMING, AN ERROR MESSAGE OCCURRED. THE CATHETER NEVER ENTERED THE PATIENT BUT WAS ALREADY SEDATED WHEN THE ISSUE OCCURRED. NO OTHER CATHETER WAS AVAILABLE SO THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10397289 ↗
• MalfunctionAug 6, 2020Display or Visual Feedback Problem; Device Difficult to Setup or Prepare; Defective Device; Display or Visual Feedback Problem; Device Difficult to Setup or Prepare; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LEFT LOWER LEG ARTERY. AN ANGIOJET SOLENT DISTA CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. HOWEVER, THE CATHETER WOULD NOT PRIME AND AN ERROR MESSAGE OCCURRED. THE WINDOW ON THE CONSOLE WAS CLEANED BUT THE CATHETER CANNOT BE RECOGNIZED NOR PRIME. THE CATHETER DID NOT ENTER THE PATIENT'S BODY BUT THE PATIENT WAS ALREADY SEDATED WHEN THE ISSUE OCCURRED AND DIAGNOSTIC CATHETER WAS ALREADY IN THE VESSEL. NO OTHER CATHETER WAS AVAILABLE SO THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10374071 ↗
• MalfunctionJul 6, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REPORTABLE BASED ON DEVICE ANALYSIS ON 24JUN2020. IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. DURING INTRODUCTION OF THE DEVICE, IT WAS NOTED THAT A "CHECK SALINE SUPPLY" ERROR MESSAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH AN ANGIOJET SOLENT OMNI CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10234308 ↗
• MalfunctionJun 18, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04JUN2020. IT WAS REPORTED THAT CATHETER FAILURE TO PRIME OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE CATHETER WOULD NOT PRIME. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PLUGGED JET HOLE.

  Patient problems: No Patient Involvement

  MAUDE report 10167816 ↗
• MalfunctionJun 5, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. VASCULAR ACCESS WAS OBTAINED UTILIZING A BRACHIAL ARM APPROACH. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN ANGIOJET SOLENT OMNI WAS USED FOR A THROMBECTOMY PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS STUCK ON THE PATIENT'S IMPLANTED STENT GRAFT WHILE THE PHYSICIAN WAS ADVANCING THE DEVICE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND FOUND OUT THAT THE TIP LOOKED FRAYED. THE PHYSICIAN WANTED TO OPEN ANOTHER CATHETER BUT AN ANGIOJET SOLENT DISTA WAS EXPIRED ON THE SHELF. IT WAS UNABLE TO PROCEED THE TREATMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123128 ↗
• MalfunctionApr 28, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27APR2020. IT WAS REPORTED THAT A BOOT LEAK OCCURRED. AN ANGIOJET SOLENT DISTA THROMBECTOMY CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE PRIMING, A LEAK WAS NOTED ON THE BULB IN THE PUMP BAG. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE WAS BROKEN 6.5 CM PROXIMAL OF THE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005200 ↗
• MalfunctionMar 9, 2020Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-FEB-2020. IT WAS REPORTED THAT DEVICE DISPLAYS ERROR MESSAGE. AFTER TWO ANGIOJET SOLENT DISTA CATHETERS WERE USED BUT FAILED THE PRIMING PROCESS, ANOTHER CATHETER WAS ADVANCED FOR A THROMBECTOMY PROCEDURE. AFTER THE CATHETER WAS SUCCESSFULLY PRIMED, THE CATHETER WAS PUT OVER THE UNKNOWN WIRE AND WAS INTRODUCED INTO THE PATIENT. HOWEVER, THE CATHETER WOULD NOT FUNCTION AND CHECK SALINE SUPPLY ERROR OCCURRED. THE PHYSICIAN ENDED UP INFUSING THE PATIENT OVERNIGHT WITH A NON-BSC DEVICE AND GOING TO LOOK AT IT AGAIN THE NEXT DAY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE AND SHAFT DETACHMENT/SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805137 ↗
• MalfunctionMar 5, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  REPORTABLE BASED ON THE DEVICE ANALYSIS ON 12FEB2020. IT WAS REPORTED THAT CATHETER FAILURE TO PRIME OCCURRED. AN ANGIOJET SOLENT DISTA CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WOULD NOT PRIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICAIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PLUGGED JET HOLE.

  Patient problems: No Patient Involvement

  MAUDE report 9793038 ↗
• MalfunctionNov 20, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER WAS STUCK ON THE GUIDE WIRE. AN ANGIOJET SOLENT DISTA CATHETER WAS USED FOR TREATMENT. DURING ADVANCEMENT OF THE DEVICE TO THE LESION INSIDE THE PATIENT, THE DEVICE GOT STUCK ON THE GUIDE WIRE. THE DEVICE WOULD NOT GO FORWARD TO THE AREA OF TREATMENT. THE CATHETER AND THE GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348597 ↗