JETSTREAM™ XC 112264-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 08714729889892), received between Aug 24, 2018 and Jul 13, 2026 — classified as 26 injuries, 236 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (67 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 262 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A 2.1MM JETSTREAM? XC ATHERECTOMY CATHETER WAS SELECTED FOR USE IN A RIGHT LEG SUPERFICIAL FEMORAL ARTERY ATHERECTOMY AND STENTING PROCEDURE. THIS DEVICE WAS ADVANCED OVER A 300CM, 0.014IN NON-BOSTON SCIENTIFIC GUIDEWIRE. AFTER THE FIRST PASS WHEN TRYING TO RETRACT THE DEVICE IN REX MODE, IT BECAME STUCK ON THE GUIDEWIRE, AND THE ENTIRE SYSTEM HAD TO BE REMOVED. GUIDEWIRE ACCESS WAS LOST. AFTER REGAINING GUIDEWIRE ACCESS, THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PROCEDURE WAS PROLONGED, BUT THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807890 ↗
• MalfunctionApr 27, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING SEAL WAS INCOMPLETE AND CONTAMINATED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A JETSTREAM? XC CATHETER WAS CHOSEN FOR AN ANGIOGRAM PROCEDURE IN THE LOWER EXTREMITY TO TREAT PERIPHERAL ARTERY DISEASE (PAD) INSIDE OF THE PATIENT. DURING PREPARATION PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE INNER PACKAGING OF THE DEVICE WAS NOT FULLY SEALED AND CONTAMINATED; HOWEVER, THERE WAS NO FOREIGN MATERIAL LOCATED IN THE PACKAGING. 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 25001072 ↗
• InjuryApr 1, 2026Failure to Advance; Device-Device Incompatibility; Noise, Audible

  IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED IN THIS EVENT. THE 95% STENOSED, OCCLUDED VESSEL WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM? XC CATHETER WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE INTENDED TO TREAT THE OCCLUDED VESSEL. DURING ADVANCEMENT TOWARD THE TARGET LESION, THE DEVICE WAS UNABLE TO PROGRESS AS EXPECTED AND AN AUDIBLE NOISE WAS NOTED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. UPON REMOVAL, A PRE-EXISTING UNKNOWN-BRAND COVERED STENT WAS NOTED TO BE ATTACHED TO THE DEVICE. A THROMBECTOMY PROCEDURE WAS ATTEMPTED TO ADDRESS THE RESULTING CONDITION, AND A BYPASS PROCEDURE WAS THEN PERFORMED TO RESTORE BLOOD FLOW. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AFTERWARDS FOR RECOVERY.

  Patient problems: Reduced Blood Flow

  MAUDE report 24758121 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISTAL EMBOLISM OCCURRED, REQUIRING AN ADDITIONAL DEVICE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A JETSTREAM XC ATHERECTOMY CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE TO TREAT ARTERIOSCLEROSIS OBLITERANS. THE JETSTREAM CATHETER WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. AFTER CROSSING WITH A WIRE VIA A CONTRALATERAL APPROACH, THE WIRE WAS EXCHANGED FOR ANOTHER NON-BOSTON SCIENTIFIC FILTER WIRE. ATHERECTOMY WAS THEN PERFORMED USING THE JETSTREAM XC ATHERECTOMY CATHETER, FIRST WITH THE 2.1-MM SIZE, FOLLOWED BY BLADE-UP ATHERECTOMY WITH THE 3.0-MM SIZE. THE FILTER USED WAS MOVING UP AND DOWN SIGNIFICANTLY INSIDE THE BLOOD VESSEL WHILE JETSTREAM CATHETER WAS IN OPERATION, WHICH MAY HAVE CAUSED BIOMATERIAL TO LEAK FROM THE FILTER. DISTAL EMBOLIZATION WAS OBSERVED ON ANGIOGRAPHY THEREAFTER. THE OCCLUDED VESSEL WAS ASPIRATED USING A MACH1 ST CATHETER, FOLLOWED BY DILATION WITH A 1.5 MM X 40 MM BALLOON. BLOOD FLOW IN THE EMBOLIZED VESSEL WAS SUCCESSFULLY RESTORED TO ITS ORIGINAL STATE. THERE WERE NO FURTHER COMPLICATIONS. ONE DAY LATER, IT WAS NOTED THAT THERE H

  Patient problems: Embolism/Embolus

  MAUDE report 24344784 ↗
• MalfunctionFeb 5, 2026Suction Failure

  IT WAS REPORTED THAT ASPIRATION FAILURE OCCURRED. A 2.1MM JETSTREAM XC CATHETER WAS SELECTED FOR A LEG ANGIOGRAM TO TREAT PERIPHERAL ARTERY DISEASE. THE JETSTREAM XC CATHETER WAS PREPPED IN ROUTINE FASHION. WHILE TREATING THE STENOSIS, BUBBLES WERE NOTICEABLE IN THE ASPIRATION TUBING, AND THE DEVICE STOPPED ASPIRATING. THE CATHETER WAS TAKEN OUT OF THE BODY AND RE-PRIMED. THE ISSUE PERSISTED SO A NEW CATHETER 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 24270473 ↗
• MalfunctionDec 17, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE GUIDEWIRE BECAME ENTRAPPED INSIDE OF THE DEVICE. THE MODERATELY TORTUOUS, 100% STENOSED CHRONIC TOTAL OCCLUSION (CTO) WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 2.1MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE TO TREAT THE CTO. DURING THE PROCEDURE, THE 2.1MM JETSTREAM XC CATHETER BECAME STUCK ON AN UNKNOWN GUIDEWIRE. BOTH THE UNKNOWN GUIDEWIRE AND 2.1MM JETSTREAM XC CATHETER WERE REMOVED TOGETHER AS ONE UNIT FROM INSIDE OF THE PATIENT. 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 23832596 ↗
• MalfunctionDec 8, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED MATERIAL SEPARATION OF THE DEVICE OCCURRED INSIDE OF THE PATIENT. THE 90% STENOSED, MODERATELY CALCIFIED TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY A 2.1MM JETSTREAM XC CATHETER WAS SUCCESSFULLY USED TO TREAT PERIPHERAL ARTERY DISEASE (PAD). AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE JETSTREAM XC CATHETER TOOK LONGER THAN EXPECTED TO ADVANCE. UPON REMOVAL OF THE JETSTREAM XC CATHETER, IT WAS NOTED THE OUTER PLASTIC MATERIAL ALONG THE SHAFT OF THE DEVICE HAD PEELED BACK. THE 2.1MM JETSTREAM XC CATHETER WAS REMOVED IN ONE PIECE AND THE PATIENT WAS CHECKED FOR ANY FOREIGN BODY, BUT NOTHING WAS FOUND TO BE LEFT INSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751030 ↗
• MalfunctionNov 24, 2025Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  IT WAS REPORTED THE DEVICE BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. A 2.1MM JETSTREAM XC CATHETER, ALONG WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE, WAS SELECTED FOR AN ANGIOGRAM AND ATHERECTOMY PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD) IN THE PATIENT'S PERIPHERAL ARTERY. DURING REMOVAL FROM THE TARGET LESION, THE DEVICE BECAME STUCK ON GUIDEWIRE AND LOSS OF ROTATION OCCURRED. THE 2.1MM JETSTREAM XC CATHETER WAS REMOVED AS ONE UNIT TOGETHER WITH THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE PROCEDURE WAS PROLONGED DUE TO THIS DEVICE MALFUNCTION DURING REMOVAL. THE TREATMENT HAD BEEN COMPLETED SUCCESSFULLY PRIOR TO THIS DEVICE MALFUNCTION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633928 ↗
• MalfunctionOct 29, 2025Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE OUTER SHEATH WAS TORN/SEPARATED. A 2.1MM JETSTREAM? XC ATHERECTOMY CATHETER WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 99% STENOSED TARGET LESION WAS MODERATELY CALCIFIED AND LOCATED IN MILDLY TORTUOUS ANATOMY. CONTRALATERAL ACCESS WAS OBTAINED, AND A 7X45 NON-BOSTON SCIENTIFIC (BSC) SHEATH AND A 300CM NON-BSC GUIDEWIRE WERE USED. THE LEFT SFA WAS TREATED WITH THE JETSTREAM? XC ATHERECTOMY CATHETER. TWO PASSES WERE MADE IN BLADES DOWN, AND ONE PASS IN BLADES UP. WHEN REMOVING THE CATHETER FROM THE SHEATH, OUTER COVER SEPARATION WAS NOTICED ALONG THE MIDDLE OF THE SHAFT AT 65-70CM. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418734 ↗
• MalfunctionOct 21, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFUSION LINE BREAK OCCURRED. A 2.1MM JETSTREAM XC CATHETER WAS CHOSEN TO TREAT A 40% STENOSED, MILDLY CALCIFIED OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING CLOSURE, A SALINE LEAK FROM A BREAK IN THE INFUSION LINE NEAR THE CONTROL POD WAS OBSERVED. THIS ISSUE OCCURRED OUTSIDE OF THE PATIENT'S BODY. THE ORIGINAL DEVICE 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 23351398 ↗
• MalfunctionSep 24, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE MATERIAL OF THE DEVICE PEELED. A 2.1MM JETSTREAM XC CATHETER WAS SELECTED TO TREAT PERIPHERAL ARTERY DISEASE (PAD) IN A 100% STENOSED, AND MILDLY CALCIFIED TARGET AREA IN THE PERIPHERAL ARTERY. DURING THE PROCEDURE, THE MATERIAL OF THE 2.1 MM JETSTREAM XC CATHETER BEGAN TO PEEL AT THE BACK END OF THE CATHETER. THE ORIGINAL 2.1 MM JETSTREAM XC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE 2.1 MM JETSTREAM XC CATHETER WAS REMOVED FROM THE PATIENT AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23134238 ↗
• MalfunctionSep 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. THIS 2.1MM JETSTREAM? XC 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 23026751 ↗
• MalfunctionAug 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE OUTER PLASTIC CASING OF THE CATHETER WAS FRAYED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. A 2.1MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ARTERIAL ANGIOPLASTY PROCEDURE TO TREAT PERIPHERAL ARTERIAL DISEASE. THE JETSTREAM XC CATHETER WAS PREPARED PROPERLY AND ADVANCED INTO THE PATIENT WITHOUT ISSUES. ONE PASS WAS COMPLETED WITHOUT ISSUE, BUT THE SECOND PASS RESULTED IN FRAYING OF THE OUTER PLASTIC CASING OF THE CATHETER AT MID SHAFT. THE CATHETER WAS PULLED OUT OF THE SHEATH INTACT. THE PROCEDURE WAS COMPLETED AFTER THE SECOND PASS AND A THIRD PASS WAS UNABLE TO BE PERFORMED, BUT THE TREATMENT WAS DEEMED MILDLY SUCCESSFUL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776460 ↗
• MalfunctionAug 7, 2025Suction Problem; Suction Problem

  IT WAS REPORTED THAT ASPIRATION STOPPED WORKING. A 2.1MM JETSTREAM? XC CATHETER WAS SELECTED FOR ENDOVASCULAR THERAPY OF THE SUPERFICIAL FEMORAL ARTERY. THE LESION HAD 100 PERCENT STENOSIS WITH SEVERE CALCIFICATION AND MODERATELY TORTUOUS. AFTER A FEW PASSES OF TREATMENT WITH BLADES UP AND DOWN, THE ROLLER PUMP WAS ROTATING BUT THERE WAS NO SUCTION FROM THE EFFLUENT TUBE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THIS DEVICE WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739843 ↗
• MalfunctionJul 18, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE WAS STUCK ON GUIDEWIRE. A 2.1 MM JETSTREAM XC CATHETER WAS SELECTED FOR A PROCEDURE IN THE LOWER EXTREMITY PERIPHERAL ARTERY TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE THE DEVICE BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE DEVICE AND GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543374 ↗
• MalfunctionJul 16, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED. THE HEAVILY CALCIFIED TARGET LESIONS WERE LOCATED IN THE POPLITEAL ARTERY AND TIBIAL ARTERY. A 2.1MM JETSTREAM XC CATHETER WAS SELECTED TO TREAT THE PATIENT FOR PERIPHERAL ARTERY DISEASE (PAD) IN THE TIBIAL ARTERY THROUGH PEDAL ACCESS. DURING THE PROCEDURE, THE DEVICE PASSED THE TIBIAL ARTERY, AND THE PHYSICIAN FELT THE DEVICE "SNAP". AFTER REMOVING THE DEVICE FROM THE PATIENT, THE PHYSICIAN OBSERVED MATERIAL SEPARATION ON THE OUTER PORTION OF THE DEVICE. THE CASE WAS COMPLETED VIA AN ALTERNATE METHOD USING ANOTHER DEVICE OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520034 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL TRAUMA OCCURRED. USING THE IPSILATERAL PROGRESSIVE APPROACH, THE FIRST 1.6 MM JETSTREAM CATHETER WAS PLACED TO TREAT LOWER EXTREMITY ARTERIAL DISEASE (LEAD) IN THE 90% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED TARGET LESION LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THEN, THE SECOND 2.1 MM JETSTREAM XC CATHETER REPLACED THE FIRST 1.6 MM JETSTREAM CATHETER. WHEN INCREASING THE SIZE TO THE SECOND 2.1 MM JETSTREAM XC CATHETER, VESSEL PERFORATION OCCURRED, AND AN ATTEMPT WAS MADE TO STOP THE BLEEDING USING A NON-BSC BALLOON. THE BALLOON WAS EXCHANGED FOR A NON-BSC STENT WHICH WAS SUCCESSFUL IN STOPPING THE BLEEDING. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 22469684 ↗
• MalfunctionJul 7, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THE DEVICE EXPERIENCED MATERIAL SEPARATION INSIDE OF THE PATIENT. THE 100% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 2.1 MM JETSTREAM XC CATHETER WAS SELECTED TO TREAT STENT RESTENOSIS IN THE DISTAL ANTERIOR TIBIAL ARTERY. DURING INSERTION, THE DEVICE, IN COMBINATION WITH A NON-BSC 7 FR GUIDE SHEATH AND 0.014 THRUWAY GUIDEWIRE, FAILED TO ADVANCE TO THE TARGET LESION. UPON REMOVAL, MATERIAL SEPARATION WAS NOTED ON THE MIDDLE SECTION OF THE DEVICE'S SHAFT. DURING THE PROCEDURE, A BREAK IN THE CATHETER OCCURRED. 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 22420913 ↗
• MalfunctionMay 22, 2025Break; Leak/Splash; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Leak/Splash; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND DEVICE FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND NON-TORTUOUS PERIPHERAL ARTERY. A 2.1MM JETSTREAM XC CATHETER WAS SELECTED TO TREAT THE PERIPHERAL ARTERY DISEASE. AFTER TREATMENT WAS COMPLETED USING THE DEVICE, THE UNIT WAS DIFFICULT TO RETRACT USING REX MODE. ONCE REMOVED INTACT OVER THE WIRE, A FRACTURE AND LEAK WERE OBSERVED MID-SHAFT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073683 ↗
• MalfunctionFeb 24, 2025Break; Entrapment of Device; Leak/Splash; Break; Entrapment of Device; Leak/Splash

  IT WAS REPORTED THAT THE INFUSION LINE RUPTURED AND BECAME STUCK ON THE WIRE. A 2.1MM JETSTREAM XC CATHETER WAS SELECTED TO TREAT TARGET LESIONS IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE INFUSION LINE RUPTURED/SEPARATED, AND THE CATHETER BECAME STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE DEVICE LEAKED FLUID FROM THE BREAK APPROXIMATELY 8-10 CENTIMETERS ABOVE THE TIP OF THE DEVICE. NO PATIENT COMPLICATIONS OCCURRED. IT WAS FURTHER REPORTED THAT THE TARGET LESIONS BEING TREATED WERE SEVERELY CALCIFIED IN THE PATIENT'S POPLITEAL ARTERY CONNECTING TO THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE BROKE DURING REMOVAL FROM THE PATIENT, AND FLUID LEAKED OUT OF THE DEVICE WHICH DID NOT INCLUDE BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21449617 ↗
• MalfunctionNov 20, 2024Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE DEVICE LOST SUCTION. THIS 2.1MM JETSTREAM XC CATHETER WAS SELECTED FOR USE DURING A LOWER EXTREMITY ANGIOGRAM PROCEDURE. DURING THE PROCEDURE DURING THE THIRD PASS WITH BLADES UP, SUCTION WAS LOST. ATTEMPTS TO CLEAR AND REGAIN SUCTION WERE UNSUCCESSFUL; THEREFORE, ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735754 ↗
• MalfunctionNov 8, 2024Failure to Advance; Material Deformation; Material Integrity Problem; Failure to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT A HOLE IN THE CATHETER OCCURRED. A 2.1MM JETSTREAM XC CATHETER WAS SELECTED TO TREAT A PATIENT WITH PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, IT WAS REPORTED THE DEVICE WAS DIFFICULT TO ADVANCE THROUGH SHEATH. IT WAS PULLED BACK THROUGH THE SHEATH TO REVEAL A HOLE ON THE OUTER CATHETER WHICH THEN FORMED A BUBBLE OF SALINE AND BURST OUTSIDE OF THE PATIENT. THE JETSTREAM WAS REMOVED FROM THE PATIENT, AND ANOTHER DEVICE OF A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639851 ↗
• MalfunctionOct 29, 2024Suction Problem; Adverse Event Without Identified Device or Use Problem; Suction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETER ASPIRATION BECAME BLOCKED ON THE FIRST AND SECOND CATHETER. THIS 2.1 MM JETSTREAM XC CATHETER WAS SELECTED FOR ATHERECTOMY TREATMENT OF LONG SEGMENT DISEASE AND INSTENT RESTENOSIS IN FEMORAL, POPLITEAL AND POSTERIOR TIBIAL ARTERY. DURING THE PROCEDURE, THE CATHETER WORKED FOR APPROXIMATELY 250 CC/SECOND OF FLUID, BUT THEN THE CATHETER BECAME BLOCKED UPON BLADES UP ON 3RD ATTEMPT. THE DEVICE WAS REMOVED TO REX IN SALINE BOWL TO CLEAR ASPIRATION PORT, AND AGAIN ATTEMPTED WITH NO REAL SUCTION OBSERVED. ANOTHER NEW 2.1 MM JETSTREAM XC CATHETER WAS OPENED AND ADVANCED SLOWLY; HOWEVER, THE NEW CATHETER ONLY WORKED ANOTHER 200 CC/SECOND OF FLUID BEFORE BECOMING BLOCKED UPON THE 4TH PASS. THE PHYSICIAN WANTED TO ADHERE TO INSTENT RESTENOSIS FURTHER AND DECIDED TO OPEN ONE MORE JETSTREAM CATHETER, WHICH WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560114 ↗
• MalfunctionOct 29, 2024Suction Problem; Adverse Event Without Identified Device or Use Problem; Suction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETER ASPIRATION BECAME BLOCKED ON THE FIRST AND SECOND CATHETER. THIS 2.1 MM JETSTREAM XC CATHETER WAS SELECTED FOR ATHERECTOMY TREATMENT OF LONG SEGMENT DISEASE AND INSTENT RESTENOSIS IN FEMORAL, POPLITEAL AND POSTERIOR TIBIAL ARTERY. DURING THE PROCEDURE, THE CATHETER WORKED FOR APPROXIMATELY 250 CC/SECOND OF FLUID, BUT THEN THE CATHETER BECAME BLOCKED UPON BLADES UP ON 3RD ATTEMPT. THE DEVICE WAS REMOVED TO REX IN SALINE BOWL TO CLEAR ASPIRATION PORT, AND AGAIN ATTEMPTED WITH NO REAL SUCTION OBSERVED. ANOTHER NEW 2.1 MM JETSTREAM XC CATHETER WAS OPENED AND ADVANCED SLOWLY; HOWEVER, THE NEW CATHETER ONLY WORKED ANOTHER 200 CC/SECOND OF FLUID BEFORE BECOMING BLOCKED UPON THE 4TH PASS. THE PHYSICIAN WANTED TO ADHERE TO INSTENT RESTENOSIS FURTHER AND DECIDED TO OPEN ONE MORE JETSTREAM CATHETER, WHICH WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560017 ↗
• MalfunctionOct 3, 2024Break; Break

  IT WAS REPORTED THAT AN INFUSION LINE BREAK OCCURRED. A 2.1MM JETSTREAM XC ATHERECTOMY CATHETER WAS SELECTED FOR A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. THE PHYSICIAN ATTEMPTED TO USE THE JETSTREAM CATHETER THROUGH A 7 FRENCH SUPER SHEATH IN THE POSTERIOR TIBIAL ARTERY. THE SHEATH WAS INSERTED WITHOUT ANY ISSUES. WHEN THE JETSTREAM CATHETER WAS INSERTED, HOWEVER, THE PLASTIC PORTION RUPTURED NEAR THE TIP OF THE CATHETER AS THE PHYSICIAN WAS TRYING TO ADVANCE THROUGH THE VESSEL. THE DEVICE WAS REMOVED INTACT, AND THE VESSEL WAS DILATED WITH A BALLOON. A SECOND JETSTREAM CATHETER WAS ABLE TO MAKE A PASS WITH LESS FORCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20361285 ↗