JETSTREAM™ SC 112260-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729889830), received between Oct 17, 2018 and Aug 28, 2026 — classified as 14 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (9 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Mechanical Problem; Nonstandard Device; Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508406 ↗
• MalfunctionJul 2, 2026Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED WITH THE GUIDEWIRE. A 1.6 MM JETSTREAM? SC CATHETER WAS USED DURING AN ENDOVASCULAR THERAPY PROCEDURE TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY WITH 100% STENOSIS. AFTER SUCCESSFUL ATHERECTOMY, RESISTANCE WAS ENCOUNTERED DURING DEVICE REMOVAL DUE TO THE CATHETER BECAME STUCK ON A THRUWAY 0.014 GUIDEWIRE. THE DEVICE AND GUIDEWIRE WERE WITHDRAWN TOGETHER AND GRADUALLY REMOVED FROM THE PATIENT. ONCE OUTSIDE THE PATIENT, THE JETSTREAM CATHETER WAS ABLE TO BE REMOVED FROM THE GUIDEWIRE BY APPLYING SIGNIFICANT FORCE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692958 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A SYMPOSIUM PRESENTATION AT ANNUAL MEETING OF THE JAPANESE ASSOCIATE OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS (CVIT2025) THAT THE INCIDENCE OF DISTAL EMBOLISM DURING PROCEDURES USING JETSTREAM ATHERECTOMY SYSTEMS AND (B)(4) IN THE CASES STUDIED FOR THE PRESENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED THROUGH GOOD FAITH EFFORT ATTEMPTS; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism/Embolus

  MAUDE report 22805367 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A PRESENTATION AT THE (B)(6) THAT THE INCIDENCE OF DISTAL EMBOLISM IN THE JET-FORWARD STUDY WAS (B)(4). JETSTREAM ATHERECTOMY CATHETERS HAVE BEEN SELECTED FOR ATHERECTOMY PROCEDURES TO TREAT HEAVILY CALCIFIED LESIONS. OF THE PROCEDURES ANALYZED IN THE JET-FORWARD STUDY PRESENTATION AT THE (B)(6) RESEARCH SYMPOSIUM, DISTAL EMBOLISM WAS REPORTED TO HAVE OCCURRED AT A (B)(4) INCIDENCE RATE. THERE WAS NO REPORTED INFORMATION REGARDING INTERVENTIONS OR THE PATIENT STATUSES FOLLOWING THE PROCEDURES.

  Patient problems: Embolism/Embolus

  MAUDE report 22800491 ↗
• MalfunctionJan 29, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE JETSTREAM CATHETER AND THE WIRE BECAME STUCK. A 1.6 MM JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS 3 CM WITH SEVERE CALCIFICATION (95 PERCENT STENOSIS) AND MODERATE TORTUOSITY. AFTER PASSING THE LESION WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE, THE PHYSICIAN TRIED TO USE A MICROCATHETER TO REPLACE THE WIRE WITH A THRUWAY RECOMMENDED FOR USE WITH JETSTREAM. UNFORTUNATELY, THE MICROCATHETER DID NOT PASS THROUGH THE LESION, SO THEY HAD NO CHOICE BUT TO CONTINUE WITHOUT THE THRUWAY. AFTER CUTTING ABOUT 90 PERCENT OF THE LESION, THE NON-BOSTON SCIENTIFIC WIRE BEGAN TO PULL FORWARD, AND EVENTUALLY THE CATHETER AND WIRE BECAME STUCK AND WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER JETSTREAM AND DRUG-COATED BALLOON WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266150 ↗
• MalfunctionNov 13, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE JETSTREAM BECAME STUCK TO THE THRUWAY GUIDEWIRE. A JETSTREAM 1.6 SC ATHERECTOMY CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT FROM THE RIGHT COMMON FEMORAL ARTERY TO THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS DONE AT A CROSSOVER, AND THE CIA BIFURCATION WAS STEEP. THE LESION WAS REPORTED AS 100 PERCENT STENOSED WITH SEVERE CALCIFICATION AND TORTUOSITY. DURING THE PROCEDURE, THE LESION PART WAS ABLATED; HOWEVER, DURING ATTEMPT TO REMOVE THE JETSTREAM CATHETER IT WAS STUCK WITH THE THRUWAY GUIDEWIRE. THE SURGEON REMOVED THE WHOLE SYSTEM TOGETHER, AND THE THRUWAY AND JETSTREAM WERE ABLE TO BE UNSTUCK OUTSIDE THE BODY CAUSING THE THRUWAY TO BECOME DEFORMED. THE PROCEDURE WAS COMPLETED WITH AN ANOTHER OF THE SAME DEVICE WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675882 ↗
• MalfunctionOct 10, 2024Failure to Advance; Defective Device; Material Deformation; Failure to Advance; Defective Device; Material Deformation

  IT WAS REPORTED THAT THE DEVICE FRACTURED. THIS 1.6MM JETSTREAM SC CATHETER WAS SELECTED FOR USE IN A BYPASS RESTENOSIS PROCEDURE. THE MODERATE TO SEVERELY TORTUOUS LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY PROXIMAL POPLITEAL BYPASS. USING AN 014 THRUWAY GUIDEWIRE, TREATMENT WITH THIS JETSTREAM CATHETER WAS STARTED; HOWEVER, A KINK WAS NOTED IN THE CATHETER AND GUIDEWIRE WHEN ATTEMPTING TO ADVANCE. IT WAS NOTED THAT THE CATHETER WAS NOT STUCK ON ANYTHING. THE CATHETER WAS REMOVED AND THE GUIDEWIRE INSIDE WAS KINKED AND UNUSABLE. THE CATHETER WAS NOT DAMAGED; THEREFORE, ANGIOPLASTY WAS PERFORMED, AND THE JETSTREAM CATHETER WAS ATTEMPTED AGAIN WITH A NEW GUIDEWIRE. IT WAS WORKING APPROPRIATELY; HOWEVER, THEN THE CATHETER WOULD NOT ADVANCE AND WAS KINKING UP ON ITSELF. THE CATHETER WAS REMOVED INTACT, AND MULTIPLE KINKS WERE NOTED THROUGHOUT. ADDITIONALLY, A FRACTURE WAS OBSERVED IN THE MIDDLE OF THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20421664 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE THAT VESSEL PERFORATION OCCURRED. FROM MARCH TO NOVEMBER 2023, 13 LESIONS WERE TREATED USING A JETSTREAM SC DEVICE FOR CALCIFIED FEMOROPOPLITEAL LESIONS FROM OUTSIDE OF THE CALCIFIED NODULE. THIS STUDY REVEALED THE RELATIONSHIP BETWEEN GUIDEWIRE POSITION AND MEDIAL INJURY AFTER USE OF JETSTREAM FOR CALCIFIED FEMOROPOPLITEAL LESION. RESULTS WERE AS FOLLOWS: THE RATE OF MEDIAL INJURY WAS SIGNIFICANTLY HIGHER IN THE OPPOSITE SIDE TO THE NODULE GROUP (75% VS. 0%, P=0.014). CONCLUSIONS: WIRE POSITION BESIDE THE CALCIFIED NODULE HAD LESS TENDENCY OF MEDIAL INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 20048791 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY DATA REPORTED COMPLICATIONS WITH THE USE OF JETSTREAM THAT LED TO DISTAL EMBOLIZATION. THE CVIT2024 ANNUAL REPORT ON THE REGISTRY DATA J-EVT WAS PRESENTED FOR A TOTAL OF 21 PATIENTS WHO UNDERWENT JETSTREAM ATHERECTOMY THERAPY FOR CALCIFIED FEMORO-POPLITEAL LESIONS AND WERE RETROSPECTIVELY ANALYZED. DURING THE PROCEDURE, SIX CASES (28.6%) EXPERIENCED DISTAL EMBOLIZATION. ON UNIVARIATE ANALYSIS, THE PRESENCE OF POOR TIBIAL RUNOFF (ONE OR NO TIBIAL ARTERY) AND SEVERE SMALL ARTERY DISEASE (SAD) WERE THE RISK FACTORS FOR DISTAL EMBOLIZATION.

  Patient problems: Embolism/Embolus

  MAUDE report 20031882 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISTAL EMBOLIZATION OCCURRED AFTER USING JETSTREAM. THE 100% STENOSED TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) THAT WAS SEVERELY CALCIFIED AND LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS ABLATED WITH A 1.6MM JETSTREAM SC CATHETER. THE LESION WAS DILATED WITH A 6MM BALLOON BUT THERE REMAINED SEVERE STENOSIS WITH CALCIFICATION. THE JETSTREAM WAS SIZED UP TO A 2.1/3.0MM, AND LESION WAS DILATED WITH A 6MM BALLOON. ANGIOGRAPHY SHOWED NO FLOW. AFTER DEPLOYING A 6.0/150MM ELUVIA DRUG-ELUTING STENT, FLOW WAS RECOVERED. FINAL ANGIOGRAM SHOWED MILD FLOW LIMIT IN FOOT, BUT IT WAS CONSIDERED ACCEPTABLE. RIGHT ANKLE-BRACHIAL INDEX (ABI) IMPROVED FROM 0.46 TO 0.99. THE PATIENT UNDERWENT 5TH TOE AMPUTATION TWO WEEKS LATER AND WAS DISCHARGED TWO MONTHS LATER.

  Patient problems: Embolism/Embolus

  MAUDE report 20023388 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY DATA REPORTED COMPLICATIONS WITH THE USE OF JETSTREAM THAT LED TO DISTAL EMBOLIZATION, REQUIRING AN ASPIRATION CATHETER, AND ARTERY RUPTURE, REQUIRING STENT-GRAFT INSERTION. THE CVIT2 024 ANNUAL REPORT ON THE REGISTRY DATA J-EVT WAS PRESENTED FOR A TOTAL OF 33 JETSTREAM CASES. WHILE ALL PROCEDURES TARGETING LESIONS WERE SUCCESSFUL, 7 CASES EXPERIENCED COMPLICATIONS. SIX CASES ENCOUNTERED DISTAL EMBOLIZATION, FORTUNATELY ACHIEVING REPERFUSION WITH AN ASPIRATION CATHETER. ONE CASE INVOLVED ARTERY RUPTURE, NECESSITATING STENT-GRAFT INSERTION.

  Patient problems: Embolism/Embolus; Perforation of Vessels

  MAUDE report 20019271 ↗
• MalfunctionJun 12, 2024Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THE DEVICE WAS STUCK ON THE GUIDEWIRE. THE 95% STENOSED, SEVERELY CALCIFIED AND MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 1.6 MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE. THE DEVICE WAS STUCK ON A NON-BSC GUIDEWIRE. THE DEVICE HAD TO BE REMOVED TOGETHER WITH THE GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522356 ↗
• MalfunctionDec 6, 2023Suction Problem; Suction Problem

  IT WAS REPORTED THAT FAILURE TO EVACUATE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 1.6MM JETSTREAM XC CATHETER WAS SELECTED FOR A SFA DILATION PROCEDURE. THE CATHETER WAS PLACED WITH A THRUWAY GUIDEWIRE. AFTER THE THIRD CUTTING, THE EVACUATION FUNCTION FAILED. THE DEVICE WAS REMOVED AND PRIMED AGAIN; HOWEVER, SALINE DID NOT FLOW THROUGH THE DEVICE DUE TO A SUSPECTED BLOCKAGE. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE OF A DIFFERENT MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277428 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DISTAL EMBOLIZATION OF THE PERONEAL ARTERY. THIS 1.6MM JETSTREAM SC CATHETER WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY ATHERECTOMY PROCEDURE. DISTAL EMBOLIZATION OF THE PERONEAL ARTERY WAS OBSERVED AFTER CUTTING WAS PERFORMED WITH THIS DEVICE. A PERCUTANEOUS INTERVENTION WAS PERFORMED APPROXIMATELY ONE WEEK LATER, AND THE PATIENT OUTCOME WAS CONSIDERED RESOLVED.

  Patient problems: Embolism/Embolus

  MAUDE report 16640517 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE BECAME ENTRAPPED IN THE CATHETER, AND TWO EMBOLISMS WERE DISCOVERED, REQUIRING ADDITIONAL INTERVENTION AND MEDICATION. A 1.6MM JETSTREAM SC ATHERECTOMY CATHETER AND A 2.1MM JETSTREAM XC ATHERECTOMY CATHETER WERE USED TOGETHER TO IN AN ENDOVASCULAR TREATMENT TO TREAT STENOSIS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) TO THE POPLITEAL ARTERY. THE PUNCTURE WAS PERFORMED FROM THE LEFT FEMORAL AND A 7 FR GUIDING SHEATH WAS INSERTED. CONTRAST IMAGING OF THE RIGHT LOWER EXTREMITY SHOWED THAT THE SFA PROXIMAL WAS FOCAL AND SEVERE CALCIFICATION OF LESS THAN 10 CM WAS OBSERVED AT THE DISTAL. THE POSTERIOR TIBIOFIBULAR CANAL WAS VISIBLE, BUT THE DISTAL AND THE ANTERIOR TIBIAL ARTERY (ATA) WERE OCCLUDED. THE BLOOD FLOW TO THE FINGERTIPS WAS SLIGHTLY FLOWING THROUGH THE COLLATERAL CIRCULATION. A 014 THRUWAY 300CM/SHORT TAPER/STRAIGHT GUIDEWIRE MANAGED TO CROSS THE LESION AND THE JETSTREAM SC ATHERECTOMY CATHETER WAS USED TO SLOWLY CUT THE PROXIMAL AND DISTAL INCISIONS. ALMOST NO CHANGE IN THE CUTTING SOUNDS WAS OBSERVED. THEN, THE JETSTREAM SC ATHERECTOMY CATHETER WAS REMOVED, AND THE JETSTREAM XC ATHERECTOMY CATHETER WAS INSERTED AND USED TO CUT EACH LESI

  Patient problems: Embolism/Embolus

  MAUDE report 16381690 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISTAL EMBOLIZATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. A JETSTREAM ATHERECTOMY CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE. DURING THE PROCEDURE, HOWEVER, A DISTAL EMBOLIZATION OCCURRED. AN ADDITIONAL ASPIRATION PROCEDURE WAS PERFORMED TO RELEASE THE EMBOLIZATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus

  MAUDE report 16274584 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISTAL EMBOLIZATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. A JETSTREAM ATHERECTOMY CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE. DURING THE PROCEDURE, HOWEVER, A DISTAL EMBOLIZATION OCCURRED. AN ADDITIONAL ASPIRATION PROCEDURE WAS PERFORMED TO RELEASE THE EMBOLIZATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus

  MAUDE report 16268772 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISTAL EMBOLIZATION OCCURRED, REQUIRING INTERVENTION. A JETSTREAM SC CATHETER, 1.6MM AND A JETSTREAM XC CATHETER, 2.1MM WERE SELECTED FOR AN ENDOVASCULAR TREATMENT. HOWEVER, A DISTAL EMBOLIZATION OCCURRED IN THE LEFT ANTERIOR TIBIAL ARTERY DURING THE PROCEDURE. PERCUTANEOUS INTERVENTION WAS PERFORMED AND THE PATIENT WAS IN RECOVERY.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16198810 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EMBOLISM OCCURRED. THE TARGET LESION WAS 99% STENOSED, SEVERELY CALCIFIED AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATION WAS PERFORMED USING A BALLOON. ATHERECTOMY WAS PERFORMED. A 1.6MM JETSTREAM CS CATHETER WAS USED FIRST, FOLLOWED BY A 2.4MM JETSTREAM XC CATHETER. AFTERWARDS, IN THE FINAL CONTRAST, A DISTAL EMBOLISM WAS OBSERVED. ASPIRATION WAS ATTEMPTED, BUT IT WAS UNSUCCESSFUL. THE LESION WAS THEN DILATED WITH A NON-BSC BALLOON AND BLOOD FLOW WAS IMPROVED ON THE FINAL CONTRAST. THE PROCEDURE WAS COMPLETED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Embolism/Embolus

  MAUDE report 16033528 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN OCCLUSION OCCURRED DUE TO DISTAL EMBOLISM POST-ABLATION PROCEDURE. INITIAL IVUS IMAGING, ON THE DAY OF THE PROCEDURE, DETERMINED IT WOULD BE TOO DIFFICULT TO CROSS THIS LESION WITH A BALLOON CATHETER, THUS TWO DIFFERENT SIZED JETSTREAM CATHETERS WERE SELECTED FOR USE IN THIS ATHERECTOMY PROCEDURE FOR TREATMENT OF CHRONIC LIMB-THREATENING ISCHEMIA AND ULCERATION ON THE LEFT FIFTH ARTERY. THE TARGET LESION WAS IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), WHICH WAS 99% STENOSED WITH SEVERE CALCIFICATION ON BOTH SIDES AND MILD TORTUOSITY. INITIAL ABLATION OF THE LESION WAS PERFORMED USING A JETSTREAM SC 1.6MM CATHETER. DURING THE ABLATION THE SPEED WAS SLOW, THE SOUND DID NOT CHANGE, THE BLADE CONTINUED ROTATING, AND THE LESION WAS ABLE TO CROSS. A SECOND ABLATION WAS PERFORMED USING A JETSTREAM XC 2.4/3.4MM CATHETER. DURING THE FIRST PASS, USING 2.4MM (BLADE DOWN), THE CATHETER WAS ABLE TO CROSS THE LESION WITHOUT ANY PROBLEM. THE SAME CATHETER WAS AGAIN USED FOR A SECOND PASS WITH 3.4MM (BLADE UP). THE ABLATION SPEED WAS STILL SLOW AND CHANGES ON SOUND/OUTFLOW WERE NOT OBSERVED. AFTER THE THREE ABLATION PASSES, FLUOROSCOPY BELOW THE KNEE WAS PERFORMED TO COMPARE T

  Patient problems: Embolism/Embolus; Ischemia; Obstruction/Occlusion

  MAUDE report 15925610 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EMBOLISM OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 1.6MM JETSTREAM SC CATHETER WAS SELECTED FOR USE IN THE ENDOVASCULAR THERAPY PROCEDURE TO TREAT THE LOWER EXTREMITY ARTERIAL DISEASE. THE JETSTREAM SC CATHETER WAS USED ALONG WITH A JETSTREAM XC CATHETER TO CUT THE LESION IN THE SFA EIGHT TIMES. PLAIN OLD BALLOON ANGIOPLASTY AND TREATMENT WITH A DRUG-COATED FOLLOWED. ON FINAL IMAGING, IT WAS NOTICED THAT PLAQUE-LIKE SUBSTANCE HAD EMBOLIZED NEAR THE TIBIOPERONEAL TRUNK AND A PERIPHERAL EMBOLIZATION OCCURRED. ASPIRATION AND A BALLOON DILATION WERE PERFORMED TO RESOLVE THE PERIPHERAL EMBOLISM.

  Patient problems: Embolism/Embolus

  MAUDE report 15597482 ↗
• MalfunctionNov 18, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE BLADES STOPPED SPINNING. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 1.6MM JETSTREAM SC ATHERECTOMY CATHETER WAS SELECTED FOR USE. THE DEVICE WAS UNABLE TO ADVANCE TO THE POSTERIOR TIBIAL ARTERY. DURING THE FIRST PASS IN BLADES DOWN, THE BLADES STOPPED SPINNING AND THE LESION WOULD NOT DEBULK. THE ASPIRATION FUNCTION WAS STILL WORKING WHEN THIS ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 2.1MM JETSTREAM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834531 ↗
• MalfunctionOct 7, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE BLADES STOPPED SPINNING DURING USE. A JETSTREAM 1.6 ATHERECTOMY CATHETER WAS BEING USED DURING A PERIPHERAL ATHERECTOMY WITH PERCUTANEOUS BALLOON ANGIOPLASTY PROCEDURE TREATING A CHRONIC TOTAL OCCLUDED SUPERFICIAL FEMORAL ARTERY WITH POPLITEAL AND POST TIBIAL LESIONS. THE DEVICE WAS USED OVER A .014 THRUWAY WIRE 300CM TO TREAT THE SFA, WITH 2 SUCCESSFUL PASSES. ON THE FIRST PASS OF THE POPLITEAL LESION, SIGNIFICANT RESISTANCE WAS FELT AND THE DEVICE STOPPED WORKING AFTER 2 MINUTES OF RUNNING INSIDE THE BODY. THE PHYSICIAN TRIED TO RESTART THE DEVICE BUT WAS UNSUCCESSFUL. NO ERROR MESSAGES WERE DISPLAYED. THE DEVICE WAS REMOVED AND A NEW JETSTREAM 1.6 WAS USED TO COMPLETE THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594487 ↗
• MalfunctionJul 27, 2021Entrapment 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 BECAME STUCK ON THE GUIDEWIRE. A JETSTREAM SC CATHETER, 1.6MM WAS SELECTED FOR USE DURING AN INFRAPOPLITEAL ATHERECTOMY PROCEDURE. DURING THE PROCEDURE, THE CATHETER BECAME STUCK ON A THRUWAY 0.014 X 300CM WIRE. THE JETSTREAM AND THRUWAY WIRES WERE REMOVED TOGETHER FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230289 ↗
• MalfunctionJun 7, 2021Entrapment of Device; Positioning Problem; Entrapment of Device; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE WIRE. A 1.6MM JETSTREAM SC CATHETER WAS SELECTED FOR USE IN A LEG ATHERECTOMY PROCEDURE. THE TARGET LESION WAS 70% STENOSED WITH NO CALCIFICATION. THE ANATOMY WAS TORTUOUS TO GET INTO THE PT VESSEL, BUT THEN IT STRAIGHTENED OUT. WHILE LOADING, THE THRUWAY GUIDEWIRE JUMPED BACK AFTER GOING THROUGH THE JETSTREAM DEVICE. ATHERECTOMY WAS COMPLETED, AND AN ATTEMPT WAS MADE TO WITHDRAW THE JETSTREAM CATHETER OVER THE WIRE. THE JETSTREAM BECAME LOCKED ON THE THRUWAY GUIDEWIRE. BOTH DEVICES HAD TO BE PULLED OUT TOGETHER, AND ACCESS WAS LOST. A NEW THRUWAY WIRE WAS OPENED IN ORDER TO BALLOON THE VESSEL, BUT IT COULD NOT BE ADVANCED BACK INTO THE VESSEL DUE TO THE TORTUOSITY. ANOTHER VESSEL WAS BALLOONED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT 2134265-2021-07255 COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946951 ↗