JETSTREAM™ SC 112262-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729889861), received between Aug 14, 2019 and Apr 9, 2026 — classified as 1 death, 9 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 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.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DISTAL EMBOLISM OCCURRED THAT REQUIRED ADDITIONAL INTERVENTION. THE 100% STENOSED, MODERATELY TORTUOUS, AND SEVERELY CALCIFIED VESSEL WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM? SC AND JETSTREAM XC CATHETERS WERE SELECTED FOR USE IN AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT LOWER EXTREMITY ARTERIAL DISEASE (LEAD). DURING THE PROCEDURE, BOTH OF THE DEVICES FUNCTIONED AS EXPECTED. THE PATIENT EXPERIENCED A DISTAL EMBOLISM THAT REQUIRED ADDITIONAL INTERVENTION. THE ADDITIONAL INTERVENTION INCLUDED EMBOLIZATION IN THE ARTERIAL TIBIAL ARTERY (ATA) AND ASPIRATION TO REMOVE THE DEBRIS. THE DEBRIS WAS SUCCESSFULLY RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE.

  Patient problems: Embolism/Embolus

  MAUDE report 24834513 ↗
• MalfunctionFeb 12, 2026Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE EMBOLIC PROTECTION DEVICE (EPD). A JETSTREAM SC CATHETER, 1.85MM, WAS SELECTED FOR USE TO TREAT STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS REPORTED TO BE 100% STENOSED WITH SEVERE CALCIFICATION. THE JETSTREAM WAS USED IN CONJUNCTION WITH A NON-BOSTON SCIENTIFIC EPD. AFTER USING THE JETSTREAM FOR ABOUT 4.5 MINUTES, REMOVAL WAS ATTEMPTED, HOWEVER, THE DEVICE BECAME ENTRAPPED ON THE EPD. BOTH THE JETSTREAM AND EPD WERE REMOVED TOGETHER AS ONE UNIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327778 ↗
• MalfunctionDec 8, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR THE ATHERECTOMY PROCEDURE TO TREAT THE LOWER EXTREMITY ARTERIAL DISEASE. A SAME-SIDE ANTEGRADE APPROACH WAS USED. A NON-BOSTON SCIENTIFIC (BSC) SHEATH WAS PLACED, AND A TOURNIQUET WAS APPLIED AT THE KNEE. HOWEVER, DUE TO CALCIFICATION, BLOOD FLOW COULD NOT BE OCCLUDED, SO A NON-BSC EMBOLIC PROTECTION DEVICE WAS USED. WHEN THE JETSTREAM WAS USED FOR CUTTING AND THEN WITHDRAWN, THE NON-BSC EMBOLIC PROTECTION DEVICE AND THE JETSTREAM BECAME ENTRAPPED AND COULD NOT BE REMOVED. WHILE TRACTION WAS APPLIED, THE FILTER PORTION OF THE NON-BSC EMBOLIC PROTECTION DEVICE BECAME SEPARATED. AFTER THE JETSTREAM WAS REMOVED, THE SEPARATED PORTION WAS SAFELY RETRIEVED WITH AN INTRAVASCULAR FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT ISSUES, AND THE PHYSICIAN REPORTED THAT THE PATIENT'S CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23747897 ↗
• MalfunctionDec 5, 2025Fluid/Blood Leak; Noise, Audible; Suction Failure; Fluid/Blood Leak; Noise, Audible; Suction Failure

  IT WAS REPORTED THAT A LOSS OF ASPIRATION OCCURRED. THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS 95% STENOSED, SEVERELY CALCIFIED AND MODERATELY TORTUOUS. A 1.85MM JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS NO SUCTION INSIDE THE PATIENT, ONLY AIR RETURNED. LIQUID WAS OBSERVED TO BE LEAKING FROM THE CONTROL POD. THE CONTROL POD ALSO MADE A HIGH-PITCH NOISE WHEN ROTATING. THE DEVICE WAS REPLACED WITH A NEW DEVICE, SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728520 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL RUPTURE OCCURRED, REQUIRING AN ADDITIONAL DEVICE. A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY PROCEDURE IN A SUPERFICIAL FEMORAL ARTERY (SFA). THE SFA CALCIFIED LESION WAS ABLATED USING THE JETSTREAM, WHICH RESULTED IN VASCULAR RUPTURE. THE DEVICE WAS ABLE TO BE REMOVED AS USUAL. AFTER THAT, A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED, AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED.

  Patient problems: Perforation of Vessels

  MAUDE report 23647197 ↗
• MalfunctionNov 7, 2025Suction Problem; Noise, Audible; Suction Failure; Suction Problem; Noise, Audible; Suction Failure

  IT WAS REPORTED THAT FAILURE TO EVACUATE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, A NOISE WAS HEARD, AND LOSS OF ASPIRATION OCCURRED. AFTER, PRIMING WAS PERFORMED BUT NOT COULD NOT BE COMPLETED SUCCESSFULLY. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496823 ↗
• MalfunctionOct 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR A PROCEDURE TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND SEVERELY CALCIFIED TARGET REGION WITH INTERMITTENT CLAUDICATION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE 1.85MM JETSTREAM SC CATHETER WAS USED IN COMBINATION WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE, THE 1.85MM JETSTREAM SC CATHETER BECAME STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304190 ↗
• MalfunctionSep 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. THIS 1.85MM JETSTREAM SC HAD NO DAMAGE TO THE OUTER BOX; HOWEVER, THE PACKAGING SEAL WAS BROKEN, SO THE CONTENTS COULD BE TAKEN OUT. IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026752 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VESSEL DISSECTION PERFORATION, AND AN ADDITIONAL DEVICE WAS REQUIRED. A 1.85MM JETSTREAM SC CATHETER WAS CHOSEN TO TREAT A 95% STENOSED, MODERATELY TORTUOUS AND CALCIFIED TARGET LESION WITH INTERMITTENT CLAUDICATION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND VESSEL OCCLUSION. DURING THE PROCEDURE, 1.85MM JETSTREAM SC CATHETER FUNCTIONED AS EXPECTED; HOWEVER, A VESSEL PERFORATION OCCURRED THAT RESULTED FROM CUTTING TOO CLOSE TO THE BLOOD VESSEL WALL. THE PERFORATION RESULTED IN INTERNAL BLEEDING, AND A NON-BOSTON SCIENTIFIC STENT WAS PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF A DIFFERENT MODEL. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

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

  MAUDE report 22952388 ↗
• MalfunctionJun 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME STUCK ON A THRUWAY GUIDEWIRE. THE 90% STENOSED, AND MODERATELY TORTUOUS TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT PERIPHERAL ARTERY DISEASE (PAD). A 1.85 MM JETSTREAM SC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE. DURING THE PROCEDURE, THE DEVICE BECAME STUCK ON THE THRUWAY GUIDEWIRE AND KINKED. THE DEVICE HAD TO BE REMOVED TOGETHER WITH THE CATHETER. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330796 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSUFFICIENT FLOW OCCURRED, AND ADDITIONAL TREATMENT WAS REQUIRED TO RESTORE BLOW FLOW INSIDE THE PATIENT. A 1.85MM JETSTREAM SC AND 2.4MM JETSTREAM XC ATHERECTOMY CATHETERS WERE SELECTED FOR USE. TO PERFORM AN ABLATION ON A MILDLY TORTUOUS, 75% STENOSED AND SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). AFTER PLACING A 6.5MM FILTERWIRE, ABLATION WAS PERFORMED ON THE DISTAL SEGMENT OF THE SFA. TWO PASSES THROUGH THE LESION WERE MADE IN BLADES-DOWN MODE, AND ONE PASS WAS MADE IN BLADES-UP MODE. AFTER BLADES-UP MODE WAS USED WITH THE XC CATHETER, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. SUBSEQUENT CONTRAST IMAGING INDICATED SLOW FLOW, AND THE DISAPPEARANCE OF FLOW IN THE ANTERIOR TIBIAL ARTERY (ATA). ADDITIONAL TREATMENT WAS PERFORMED TO RESTORE BLOOD FLOW IN THE ARTERY, THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Reduced Blood Flow

  MAUDE report 21574140 ↗
• InjuryAug 9, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED DURING AN ACADEMIC CONFERENCE THAT FILTER WIRE ENTRAPMENT OCCURRED. AS A RESULT, AN OBSTRUCTION OCCURRED, REQUIRING MEDICAL INTERVENTION. THE JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY (EVT) PROCEDURE IN A TARGET LESION THAT EXTENDED FROM THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) TO THE POPLITEAL P1. THE TARGET LESION WAS 90% STENOSED WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE JETSTREAM WAS USED IN CONJUNCTION WITH A NON-BOSTON SCIENTIFIC (BSC) FILTER WIRE. AFTER COMPLETING THE CUTTING WITH JETSTREAM, THE FILTER WIRE AND JETSTREAM WERE STUCK WHEN IT WAS ATTEMPTED TO BE REMOVED WITH REX. THE JETSTREAM AND FILTER WIRE WERE BEING REMOVED TOGETHER, BUT THE FILTER PART OF THE FILTER WIRE GOT CAUGHT IN THE FRONT PORTION OF THE LESION THAT WAS NOT TREATED BY JETSTREAM. THE COLLECTED MATERIAL INSIDE THE FILTER WAS SQUEEZED OUT OF THE FILTER PART. THIS CAUSED THE PERONEAL PORTION OF ONE BELOW-THE-KNEE (BTK) RUNOFF TO BECOME OBSTRUCTED. AFTER ADDITIONAL TREATMENT, THE FLOW IMPROVED, AND THE PROCEDURE WAS COMPLETED. THE NEXT DAY, BOTH THE SFA AND BK WERE RE-OCCLUDED, SO EVT WAS PERFORMED AGAIN. A NON-BSC STENT WAS IMPLANTED IN THE SF

  Patient problems: Obstruction/Occlusion

  MAUDE report 19955201 ↗
• DeathMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. A 1.85MM JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR A PROCEDURE DURING A NON-BOSTON SCIENTIFIC WORKSHOP. THE JETSTREAM WAS USED IN ADDITION TO A RANGER BALLOON, A JUPITERFC, A THRUWAY14, AND NON-BOSTON SCIENTIFIC DEVICES. IT WAS REPORTED THAT THE NEXT DAY OR THE DAY AFTER, THE PATIENT DIED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228956 ↗
• MalfunctionMar 19, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. THIS 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. THE 50% STENOSED, MODERATELY CALCIFIED, AND MILDLY TORTUOUS TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, ABLATION OF THE DISTAL SFA LESION WAS PERFORMED TWICE. THEN IT WAS ATTEMPTED TO REMOVE THE JETSTREAM CATHETER; HOWEVER, IT BECAME STUCK IN THE NON-BOSTON SCIENTIFIC GUIDEWIRE LUMEN. THE DEVICES WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935747 ↗
• MalfunctionJan 8, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR THE ATHERECTOMY PROCEDURE. DURING DEVICE REMOVAL AFTER LESION CUTTING BY THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS ENTRAPPED ON THE GUIDEWIRE. BOTH DEVICE AND GUIDEWIRE HAD TO BE REMOVED TOGETHER. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED WITH THE ORIGINAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464121 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANEURYSM OCCURRED, REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN THE OPENING OF THE SUPERFICIAL FEMORAL ARTERY. A 1.85MM JETSTREAM SC ATHERECTOMY CATHETER WAS USED, FOLLOWED BY TWO 2.1MM JETSTREAM XC ATHERECTOMY CATHETERS FOR AN ENDOVASCULAR THERAPY PROCEDURE TO TREAT RESTENOSIS. DURING THE PROCEDURE, THE LESION WAS SCRAPED DOWN TO THE ADVENTITIA, WHICH RESULTED IN AN ANEURYSM. ENDARTERECTOMY AND VASCULAR REPAIR WERE REQUIRED TO RESOLVE THE ANEURYSM. THE PATIENT WAS REPORTED TO BE IN RECOVERY.

  Patient problems: Aneurysm; Perforation of Vessels; Pseudoaneurysm

  MAUDE report 18457340 ↗
• MalfunctionDec 20, 2023Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JETSTREAM CATHETER AND THE WIRE BECAME STUCK. A 1.85 MM JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR TREATMENT OF PERIPHERAL ARTERIAL DISEASE. DURING THE PROCEDURE, THE JETSTREAM AND WIRE BECOME STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER JETSTREAM WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366200 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PSEUDOANEURYSM OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION LENGTH WAS 50MM. THE LESION WAS CUT TWICE WITH A 1.85MM JETSTREAM SC CATHETER AND WAS CUT ONCE WITH A 2.4MM JETSTREAM XC CATHETER DURING THE INDEX PROCEDURE ON (B)(6) 2022. ON (B)(6) 2023, LOWER EXTREMITY ULTRASOUND SHOWED NO INDICATION OF PSEUDOANEURYSM AND NO RESTENOSIS. AT THE OUTPATIENT CLINIC ON (B)(6) 2023, RESTENOSIS OF THE RIGHT SFA WAS SUSPECTED BY LOWER EXTREMITY ARTERY ULTRASOUND. A PSEUDOANEURYSM WAS THEN DIAGNOSED AT ANGIO WHEN REVASCULARIZATION WAS PERFORMED ON (B)(6) 2023. AS A RESULT, ON (B)(6) 2023, PSEUDOANEURYSM CLOSURE AND ENDARTERECTOMY WERE PERFORMED UNDER GENERAL ANESTHESIA. THE ADVENTITIAL STRUCTURE WAS PARTIALLY DESTROYED ON THE OUTSIDE OF THE PROXIMAL PART OF THE RIGHT SFA, AND AFTER RESECTING THE SAME PART, A PATCH OF BOVINE PERICARDIUM WAS APPLIED IN THE FAN DIRECTION, AND ENDARTERECTOMY WAS PERFORMED CENTRALLY AND PERIPHERALLY, AND A BOVINE PERICARDIUM PATCH WAS APPLIED TO THE VASCULAR CALCIFICATION. PLASTIC SURGERY WAS PERFORMED USING A BOVINE PERICARDIAL PATCH. IVUS AT THE TIME OF THE INITIAL TREATMEN

  Patient problems: Pseudoaneurysm

  MAUDE report 18120766 ↗
• MalfunctionNov 8, 2023Entrapment of Device; Mechanical Problem; Unintended Movement; Noise, Audible; Entrapment of Device; Mechanical Problem; Unintended Movement; Noise, Audible

  IT WAS REPORTED THAT THE CATHETER WAS ENTRAPPED ON THE GUIDEWIRE. A 1.85MM JETSTREAM XC CATHETER AND NON-BSC FILTERWIRE WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE TO TREAT A NON-HEALING WOUND OF THE RIGHT FOOT. THE TARGET LESION WAS LOCATED IN THE RIGHT POPLITEAL ARTERY. THE CATHETER WAS SUCCESSFULLY PREPPED AND ADVANCED TO THE TARGET LESION. UPON INITIAL ACTIVATION, THE FILTERWIRE POSITIONING IN THE CATHETER CHANGED, INSTEAD OF STAYING IN ITS ORIGINAL POSITION. BEFORE ENGAGING THE LESION, THE SOUND OF THE DEVICE SEEMED SLOWER, AND WHILE ENGAGING THE LESION THE CATHETER BOGGED DOWN. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN OPTED TO REMOVE THE CATHETER. HOWEVER, THE CATHETER WAS ENTRAPPED ON THE FILTERWIRE AND THEREFORE, THE CATHETER AND FILTERWIRE HAD TO BE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A BALLOON AND CUTTING-BALLOON. THE PATIENT WAS STABLE THE ENTIRE PROCEDURE AND THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095379 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SLOW FLOW OCCURRED REQUIRING AMPUTATION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 2.4MM JETSTREAM XC, 1.85MM JETSTREAM SC AND A RANGER BALLOON WERE SELECTED FOR USE. WHILE USING THE SC 1.85, WHICH WORKED AS INTENDED, IT ALMOST GOT STUCK, BUT BY FIXING THE TIP OF THE CATHETER IN PLACE, THE RESISTANCE WAS RELIEVED, AND IT WAS POSSIBLE TO CONTINUE USING IT AS BEFORE. TREATMENT WAS STARTED FROM THE RIGHT GROIN IN AN IPSILATERAL ANTEGRADE DIRECTION. THE SFA LESION WAS PASSED EASILY WITH A 0.035 INCH GUIDE WIRE. TO TREAT BELOW THE KNEE FIRST, CHANGED TO A 0.014 INCH GUIDE WIRE, PASSED THROUGH THE LESION IN THE POSTERIOR TIBIAL ARTERY, EXPANDED THE BALLOON, AND CHECKED THE BLOOD FLOW BELOW THE KNEE. THE GUIDE WIRE WAS REPLACED WITH A THRUWAY 0.014 AND 5-6 CM OF SEVERELY CALCIFIED SFA LESION WAS TREATED USING THE JETSTREAM SC 1.85 MM AND XC 2.4 MM. THE LESION LENGTH WAS 2-3 CM. THE LESION WAS PRE-DILATED WITH A 6MM DIAMETER BALLOON AND RANGER 6X150. SLOW FLOW WAS OBSERVED IN THE SFA ON THE FINAL CONTRAST IMAGE. A VASODILATOR WAS ADMINISTERED. ALTHOUGH THE SLOW FLOW SITUATION CONTINU

  Patient problems: Embolism/Embolus; Pain

  MAUDE report 18083378 ↗
• MalfunctionOct 19, 2023Entrapment of Device; Mechanical Problem; Material Deformation; Entrapment of Device; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE JETSTREAM CATHETER AND WIRE BECAME STUCK. A 1.85MM JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR ENDOVASCULAR THERAPY THE SUPERFICIAL FEMORAL ARTERY USING CONTRALATERAL APPROACH. WHEN ADVANCING THE CATHETER, THE ANGLE OF THE COMMON ILIAC ARTERY BRANCH WAS TIGHT AND DIFFICULT TO ROTATE THE 7F DESTINATION TO THE CONTRALATERAL SIDE, AND IT WAS ALSO NOTED THERE WAS TROUBLE WITH BALLOON ANCHORS. DURING THE JETSTREAM PROCEDURE, THE ROTATION STOPPED WHEN IT WAS ATTEMPTED TO BREAK THROUGH THE STENOSIS WHERE CALCIFICATION WAS THE MOST SEVERE. THERE WAS NO PROBLEM AT THE BEGINNING OF THE LESION, BUT A LOT OF RESISTANCE WAS FELT WHEN THE CATHETER WAS BROUGHT TO THE LESION AFTER ABOUT 3 SECONDS. THE JETSTREAM ALSO BECAME STUCK WITH THE THRUWAY WIRE, AND THE PRODUCTS HAD TO BE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN ANOTHER JETSTREAM DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966281 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE TO TREAT THE PERIPHERAL ARTERY DISEASE. AFTER PASSING THE GUIDEWIRE THROUGH, INTRAVASCULAR ULTRASOUND WAS PERFORMED TO CHECK THE CHARACTERISTICS OF THE LESION. DURING THAT TIME, A PART OF THE GUIDEWIRE PASSED THROUGH THE TUNICA MEDIA OF THE BLOOD VESSEL, AND IT WAS NOT NOTICED. IT WAS THOUGHT THAT THE JETSTREAM THAT WAS OPERATED AT THE SAME PART CUT THROUGH IT, WHICH LED TO THE PERFORATION OF THE BLOOD VESSEL. IN ADDITION, CONTRAST IMAGING FOR CONFIRMATION WAS PERFORMED AFTER JETSTREAM CUTTING LEAVING THE CHRONIC TOTAL OCCLUSION (CTO) DISTAL CAP. IT IS ALSO POSSIBLE THAT THE INTRAVASCULAR PRESSURE INCREASED WHEN FLUSHING VIGOROUSLY FOR THE CONTRAST IMAGING, WHICH SUPPORTED THE PERFORATION OF THE BLOOD VESSEL. THE JETSTREAM WAS REMOVED NORMALLY, AND A NON-BOSTON SCIENTIFIC STENT WAS PLACED IN THE PERFORATED VESSEL. COMPLETE HEMOSTASIS WAS CONFIRMED, AND BAILOUT WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER COMPL

  Patient problems: Perforation of Vessels

  MAUDE report 17484072 ↗
• MalfunctionFeb 22, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE GUIDEWIRE. A 1.85MM JETSTREAM SC WAS SELECTED FOR USE IN A RIGHT LEG ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE JETSTREAM CATHETER BECAME STUCK ON A .014 NON-BOSTON SCIENTIFIC GUIDEWIRE IN THE SFA. THE JETSTREAM WOULD STILL OPERATE IN 3 FUNCTIONS [ROTATIONS/ASPIRATION/INFUSION] BUT WOULD NO LONGER MOVE. EVENTUALLY, THEY WERE ABLE TO GET THE WIRE OUT. HOWEVER, THEY COULD NOT GET A NEW NON-BOSTON SCIENTIFIC GUIDEWIRE BACK IN AND THE ENTIRE SYSTEM HAD TO BE REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. A SECOND DEVICE WAS OPENED, AND THE PROCEDURE WAS ABLE TO BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362690 ↗
• MalfunctionJan 15, 2021Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE WIRE, AND THE PROCEDURE WAS CANCELLED POST-SEDATION. A 1.85MM JETSTREAM SC WAS SELECTED FOR USE IN A LEFT LEG ANGIOPLASTY PROCEDURE WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE DEVICE BECAME STUCK ON THE WIRE WITHIN THE SFA. THE DEVICE WOULD NOT BUDGE SO BOTH THE CATHETER AND WIRE WERE REMOVED TOGETHER AS A SYSTEM. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11178855 ↗
• MalfunctionDec 11, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE GUIDEWIRE. A 1.85MM JETSTREAM SC WAS SELECTED FOR USE IN A RIGHT LEG ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE JETSTREAM CATHETER BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE IN THE SFA. THE JETSTREAM WOULD NOT BUDGE; THEREFORE, BOTH THE CATHETER AND THE WIRE WERE REMOVED. SINCE WIRE ACCESS WAS LOST, THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10993126 ↗