JETSTREAM™ XC 112266-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 08714729889922), received between Aug 9, 2018 and Aug 17, 2026 — classified as 28 injuries, 260 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (69 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 288 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50284734 ↗
• MalfunctionAug 13, 2026Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243496 ↗
• MalfunctionAug 6, 2026Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161549 ↗
• MalfunctionJul 31, 2026Difficult to Remove; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099816 ↗
• MalfunctionJul 8, 2026Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS ENTRAPPED WITH THE FILTER WIRE. A 2.4 MM JETSTREAM? XC CATHETER WAS USED WITH A FILTRAP FILTER WIRE DURING AN ENDOVASCULAR THERAPY PROCEDURE TO TREAT A 99% OCCLUDED SUPERFICIAL FEMORAL ARTERY LESION WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. FOLLOWING ATHERECTOMY, THE JETSTREAM DEVICE BECAME STUCK WITH THE FILTER WIRE AND WAS DIFFICULT TO WITHDRAW. THIS REQUIRED FORCEFUL REMOVAL AND THE JETSTREAM CATHETER AND FILTER WIRE 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 25749371 ↗
• MalfunctionJun 29, 2026Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A 2.4 MM JETSTREAM? XC ATHERECTOMY CATHETER WAS USED DURING A SUPERFICIAL FEMORAL ARTERY ANGIOGRAM PROCEDURE TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 60% STENOSIS. FOLLOWING SUCCESSFUL USE OF THE CATHETER, THE DEVICE COULD NOT BE REMOVED AND WAS STRETCHED PROXIMAL TO THE INFUSION PORTS. THE CATHETER WAS MANUALLY REMOVED BY PULLING FROM THE PATIENT IN ONE PIECE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659545 ↗
• MalfunctionMay 20, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A JETSTREAM? XC CATHETER WAS SELECTED FOR A LOWER EXTREMITIES (LE) ANGIOGRAM TO TREAT PERIPHERAL ARTERY DISEASE (PAD). WHEN THE OUTER PACKAGE WAS OPENED, HOWEVER, IT WAS NOTED THAT THE INNER COVER WAS NOT FULLY SEALED, COMPROMISING THE DEVICE STERILITY. THE DEVICE WAS NOT USED INSIDE OF THE PATIENT. AN ALTERNATE JETSTREAM 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 25234727 ↗
• MalfunctionApr 15, 2026Suction Failure

  IT WAS REPORTED THAT FAILURE TO EVACUATE OCCURRED. THE 90% STENOSED, MILDLY TORTUOUS, AND SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM? XC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT INTERMITTENT CLAUDICATION IN THE RIGHT SFA. DURING THE PROCEDURE, LOSS OF ASPIRATION OCCURRED. THE DEVICE WAS RE-PRIMED; HOWEVER, THIS DID NOT RESOLVE THE LOSS OF ASPIRATION ISSUE. 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 24888493 ↗
• MalfunctionMar 26, 2026Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED WITH THE DEVICE. A 2.4MM JETSTREAM XC DEVICE WAS SELECTED FOR A POPLITEAL ANGIOGRAM TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) THROMBUS OCCLUSION. DURING THE PROCEDURE, SEVERAL PASSES WERE MADE WITH JETSTREAM WITHOUT ISSUE. WHEN REMOVING THE JETSTREAM DEVICE, DIFFICULTY WAS ENCOUNTERED WHEN REMOVING IT OVER THE WIRE. THE DEVICE WAS FULLY REMOVED FROM THE GUIDEWIRE, AND ANOTHER ATTEMPT WAS MADE TO PUT THE JETSTREAM BACK ON THE GUIDEWIRE AND INTO THE PATIENT. THE DEVICE COULD NOT BE RELOADED ONTO THE GUIDEWIRE BEYOND 1CM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A BOSTON SCIENTIFIC THRUWAY GUIDEWIRE WAS THE GUIDEWIRE INVOLVED IN THIS EVENT. IN ADDITION, THE 100% STENOSED TARGET LESION WAS SEVERELY CALCIFIED, AND MODERATELY TORTUOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707061 ↗
• MalfunctionMar 12, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED MATERIAL SEPARATION OCCURRED WITH THE DEVICE. THE 70% STENOSED, MILDLY CALCIFIED AND TORTUOUS LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A JETSTREAM? XC WAS SELECTED FOR A LOWER EXTREMITY ANGIOGRAM PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, A SEGMENT OF THE OUTER TUBING MATERIAL OF THE DEVICE SEPARATED. THE PORTION OF THE DEVICE WAS OUTSIDE OF THE PATIENT'S BODY AT THE TIME OF THE MATERIAL SEPARATION. THE DEVICE WAS REMOVED INTACT. 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 24586447 ↗
• MalfunctionMar 11, 2026Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. SEVERE CALCIFICATION WAS ALSO NOTED FROM THE MID TO DISTAL PART OF THE SUPERFICIAL FEMORAL ARTERY. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY PROCEDURE. AFTER PERFORMING COMPLETE ABLATION WITH A JETSTREAM SC ATHERECTOMY CATHETER, THE CATHETER WAS REPLACED WITH THE 2.4MM JETSTREAM XC CATHETER. WHILE PERFORMING ABLATION FROM THE PROXIMAL TO MID AND DISTAL SUPERFICIAL FEMORAL ARTERY, IT SUDDENLY GOT STUCK WITH NON-BOSTON SCIENTIFIC FILTER WIRE AND COULD NOT BE ADVANCED. BOTH THE FILTER WIRE AND JETSTREAM CATHETER WERE REMOVED TOGETHER. THE GUIDEWIRE WAS REPLACED WITH THRUWAY 0.014 300CM, AND THE PROCEDURE WAS CONTINUED USING A NEW JETSTREAM CATHETER OF THE SAME SIZE; THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576396 ↗
• MalfunctionMar 4, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THE DEVICE BECAME KINKED AND STUCK ON THE GUIDEWIRE. THE MILDLY CALCIFIED AND MODERATELY TORTUOUS TARGET AREA WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A JETSTREAM XC DEVICE WAS SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE SFA TO TREAT THE TARGET OCCLUSION. DURING THE PROCEDURE THE JETSTREAM XC BECAME KINKED, DISTAL TO THE INFUSION PORT ON THE DEVICE, WHEN ATTEMPTING TO PASS THROUGH A BIFURCATION. THEN, THE DEVICE BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE JETSTREAM XC AND NON-BOSTON SCIENTIFIC GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. A DIFFERENT DEVICE WITH A NEW GUIDEWIRE 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 24506581 ↗
• MalfunctionFeb 26, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR A LOWER EXTREMITIES (LE) ANGIOGRAM TO TREAT PERIPHERAL ARTERY DISEASE (PAD). WHEN THE OUTER PACKAGE WAS OPENED, HOWEVER, IT WAS NOTED THAT THE INNER COVER WAS NOT FULLY SEALED, COMPROMISING THE DEVICE STERILITY. AN ALTERNATE JETSTREAM 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 24455363 ↗
• MalfunctionFeb 25, 2026Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND WAS DIFFICULT TO REMOVE. THE 100% STENOSED, SEVERELY CALCIFIED TARGET AREA WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 2.4 MM JETSTREAM? XC CATHETER WAS SELECTED FOR AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE IN THE SFA TO TREAT LOWER EXTREMITY ARTERY STENOSIS. DURING THE PROCEDURE THE JETSTREAM? XC CATHETER BECAME STUCK ON A NON-BOSTON SCIENTIFIC FILTER WIRE GUIDEWIRE AND THE JETSTREAM? XC CATHETER WAS DIFFICULT TO REMOVE FROM INSIDE OF THE PATIENT. THE JETSTREAM? XC CATHETER AND NON-BOSTON SCIENTIFIC FILTER WIRE GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE NON-BOSTON SCIENTIFIC FILTER WIRE GUIDEWIRE COULD NOT BE REMOVED FROM THE JETSTREAM? XC CATHETER WHEN OUTSIDE OF THE PATIENT. ANOTHER DEVICE OF A DIFFERENT 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 24447603 ↗
• MalfunctionFeb 19, 2026Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME STUCK ON THE GUIDEWIRE. THE 70% STENOSED AND MODERATELY CALCIFIED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 2.4MM JETSTREAM? XC CATHETER WAS SELECTED FOR A LOWER EXTREMITY (LE) ANGIOGRAM AND ATHERECTOMY PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD) IN THE SFA. BOSTON SCIENTIFIC'S ROTAGLIDE ATHERECTOMY LUBRICANT WAS USED WITH THE JETSTREAM? XC CATHETER. DURING THE PROCEDURE, THE JETSTREAM? XC CATHETER COULD NOT BE REMOVED, AND THE DEVICE BECAME ENTRAPPED ON THE UNKNOWN-BRAND GUIDEWIRE. BOTH THE JETSTREAM? XC CATHETER AND THE UNKNOWN-BRAND GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE UNKNOWN-BRAND GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE JETSTREAM? XC CATHETER ONCE OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397047 ↗
• MalfunctionJan 29, 2026Mechanical Problem; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THIS 2.4MM JETSTREAM XC CATHETER CATHETER WAS SELECTED FOR USE DURING AN ATHERECTOMY PROCEDURE TO TREAT A 100% OCCLUDED, MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION. DURING THE PROCEDURE, A WIRE WAS PLACED ACROSS THE LESION, THEN THE JETSTREAM CATHETER WAS UNABLE TO CROSS THE LESION AND BECAME BOGGED DOWN, THEN STALLED OUT DESPITE EFFORTS TO OVERCOME THIS CHALLENGE. WIRE ACCESS WAS LOST DURING THE REMOVAL OF THE JETSTREAM AND WAS NOT ABLE TO BE REESTABLISHED. THEREFORE, THE CASE WAS CANCELLED AND RESCHEDULED FOR ANOTHER DATE, USING ALTERNATIVE METHODS. THE PATIENT HAD RECEIVED MODERATE SEDATION AND LOCAL ANESTHETIC FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS NOTED THAT THE CATHETER OPERATED CORRECTLY AND DID NOT CONTRIBUTE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24216073 ↗
• MalfunctionJan 21, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED MATERIAL DEFORMATION OCCURRED ON THE DEVICE. A 1.85MM JETSTREAM SC CATHETER WAS SELECTED FOR A PROCEDURE TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED AND 99% STENOSED TARGET LESION INSIDE THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, LOSS OF ROTATION OCCURRED WITH THE 1.85MM JETSTREAM SC CATHETER. THE 1.85MM JETSTREAM SC CATHETER WAS REMOVED AND REPLACED WITH A 1.6 MM JETSTREAM SC CATHETER THAT WAS USED SUCCESSFULLY INSIDE OF THE PATIENT. THEN, 2.4MM JETSTREAM XC CATHETER WAS SUCCESSFULLY PRIMED AND USED INSIDE OF THE PATIENT; HOWEVER, A BALLOON-LIKE DEFORMATION OCCURRED ON THE DEVICE APPROXIMATELY 10 CM FROM THE TIP OF THE DEVICE. THE FUNCTIONS OF THE 2.4MM JETSTREAM XC CATHETER WERE UNAFFECTED AND THE 2.4MM JETSTREAM XC 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 24140556 ↗
• MalfunctionDec 19, 2025Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THE DEVICE BECAME STUCK ON A GUIDEWIRE. A 2.4 MM JETSTREAM XC CATHETER WAS SELECTED FOR A LEG ANGIOGRAM PROCEDURE TO TREAT CLAUDICATION. DURING THE PROCEDURE THE DEVICE BECAME STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. BOTH THE 2.4 MM JETSTREAM XC CATHETER AND NON-BOSTON SCIENTIFIC GUIDEWIRE HAD TO BE REMOVED FROM INSIDE OF THE PATIENT AS ONE UNIT. WHEN THE 2.4 MM JETSTREAM XC CATHETER WAS SEPARATED FROM THE NON-BOSTON SCIENTIFIC GUIDEWIRE, THE DEVICE STOPPED WORKING AS EXPECTED. A NEW 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 23850802 ↗
• MalfunctionDec 17, 2025Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THE DEVICE MATERIAL SEPARATED INSIDE OF THE PATIENT. THE MODERATELY CALCIFIED, AND MODERATELY TORTUOUS OCCLUSION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ANGIOGRAM TO TREAT THE OCCLUSION. DURING THE PROCEDURE, THE CATHETER BECAME STUCK AT A BIFURCATION INSIDE OF THE PATIENT AND THE CATHETER BROKE WHEN BEING REMOVED. THE CATHETER WAS ABLE TO BE REMOVED IN ONE PIECE FROM INSIDE OF THE PATIENT, AND AN ALTERNATE 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 23834076 ↗
• MalfunctionDec 2, 2025Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR A LOWER EXTREMITY ANGIOGRAM PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, RESISTANCE OCCURRED WHEN LOADING THE NON-BOSTON SCIENTIFIC GUIDEWIRE INTO THE 2.4MM JETSTREAM XC CATHETER. THE 2.4MM JETSTREAM XC CATHETER WAS DIFFICULT TO ADVANCE AND REMOVE FROM GUIDEWIRE INSIDE OF THE PATIENT. THE CATHETER WAS ULTIMATELY REMOVED FROM THE GUIDEWIRE BY A PIN AND PULL METHOD. THE SAME CATHETER WAS ATTEMPTED FOR USE AGAIN WITH A NEW GUIDEWIRE, HOWEVER THERE WAS RESISTANCE LOADING THE CATHETER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695617 ↗
• MalfunctionNov 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A 2.4MM JETSTREAM XC ATHERECTOMY CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE. DURING REMOVAL, IT WAS NOTED THAT THE DEVICE HAD FRACTURED. THE DEVICE WAS ABLE TO BE REMOVED INTACT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574248 ↗
• InjuryNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE SHEARED OFF DURING THE USE OF THIS DEVICE, RESULTING IN ATTEMPTS TO RETRIEVE THE FRAGMENT AND PAIN TO THE PATIENT. THIS 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR USE DURING A JETSTREAM ATHERECTOMY OF IN-STENT RESTENOSIS OF THE LEFT POPLITEAL AND LEFT POSTERIOR TIBIAL. DURING THE PROCEDURE, THE JETSTREAM DEVICE WAS BEING USED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE AND WHILE USING THE JETSTREAM DEVICE IN THE DISTAL SEGMENT, THE GUIDEWIRE SHEARED OFF AND WAS LEFT IN THE PATIENTS LEFT POSTERIOR TIBIAL ARTERY. IT WAS NOTED THAT THE JETSTREAM DEVICE WAS POSSIBLY SPINNING IN ONE SEGMENT LONGER THAN EXPECTED. THE PHYSICIAN ATTEMPTED FOR TWO HOURS TO RETRIEVE THE DISTAL END OF THE WIRE. THE PATIENT EXPERIENCED DISCOMFORT/PAIN AND RECEIVED PAIN MEDICATION; HOWEVER, IT WAS NOTED THAT IT MAY HAVE BEEN GIVEN FOR THE PATIENTS OVERALL HEALTH ISSUES AND BEING IN THE PROCEDURE FOR A LONGER PERIOD.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 23535509 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED A VASCULAR PERFORATION. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, THE 2.4MM JETSTREAM XC CATHETER FUNCTIONED AS EXPECTED. WHEN IMAGING WAS USED TO CONFIRM TREATMENT, A VASCULAR PERFORATION WAS OBSERVED. AN UNKNOWN-BRAND STENT WAS PLACED TO TREAT THIS PATIENT COMPLICATION AND HEMOSTASIS WAS CONFIRMED SO THE PROCEDURE WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD INTERMITTENT CLAUDICATION OF THE LEFT LOWER EXTREMITY WITH RUTHERFORD STAGE III CLASSIFICATION. AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE WAS PERFORMED ON THE AFFECTED SIDE WITH AN ANKLE-BRACHIAL INDEX (ABI) OF 0.70. DURING A COMPUTED TOMOGRAPHY (CT) PROCEDURE, INTRAVASCULAR ULTRASOUND (IVUS) INDICATED THE AFFECTED AREA REQUIRED DEBULKING, SO AN UNKNOW-BRAND CATHETER WAS USED. THE UNKNOW-BRAND CATHETER WAS FOLLOWED BY A 2.4MM JETSTREAM XC CATHETER TO TREAT THE PATIENT. A VASCULAR PERFORATION WAS NOTED, AND HEMOSTASIS W

  Patient problems: Perforation of Vessels

  MAUDE report 23497368 ↗
• MalfunctionOct 31, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE DEVICE WAS DIFFICULT TO REMOVE. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE TO TREAT STENOSIS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). WHEN REMOVING THE 2.4MM JETSTREAM XC CATHETER FROM THE NON-BOSTON SCIENTIFIC SHEATH, THE 2.4MM JETSTREAM XC CATHETER BECAME STUCK AND WAS DIFFICULT TO REMOVE. BOTH THE 2.4MM JETSTREAM XC CATHETER AND THE NON-BOSTON SCIENTIFIC SHEATH HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE CASE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DRUG-COATED BALLOON AS PLANNED FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437172 ↗
• MalfunctionOct 30, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER WAS PEELING AND LEAKING SALINE. A 2.4MM JETSTREAM? XC ATHERECTOMY CATHETER WAS SELECTED FOR USE IN A PERIPHERAL ATHERECTOMY PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE. DURING THE PROCEDURE, THE CATHETER STARTED PEELING, AND THE DEVICE WAS LEAKING SALINE FROM THE SHAFT. AN ALTERNATE DEVICE WAS USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431103 ↗