JETSTREAM™ PVCN100 050599-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729890430), received between May 5, 2020 and Jun 2, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO (B)(6) STUDY AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. A TARGET LESION LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) HAD 95% OCCLUSION, REFERENCE VESSEL DIAMETER OF 4MM, LENGTH OF 30MM, AND IT WAS CLASSIFIED AS A TASC II A LESION. THE TARGET LESION WAS TREATED WITH A 2.1/3.0MM JETSTREAM CATHETER. THE RESIDUAL STENOSIS POST JETSTREAM ATHERECTOMY WAS 100%. POST TREATMENT, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED, WITH 0% FINAL RESIDUAL STENOSIS. ON (B)(6) 2021, DURING THE INDEX PROCEDURE, POST TREATMENT OF TARGET LESION WITH JETSTREAM CATHETER, AN F-TYPE DISSECTION OF THE SFA TARGET LESION WAS NOTED. PTA AND STENTING WERE PERFORMED IN THE TARGET VESSEL TO TREAT THE EVENT. ON (B)(6) 2021, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

  Patient problems: Vascular Dissection

  MAUDE report 11924256 ↗
• MalfunctionMay 28, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS A FAILURE TO ASPIRATE. A 2.1MM JETSTREAM XC CATHETER AND A JETSTREAM CONSOLE WERE SELECTED FOR USE IN A LOWER EXTREMITY ATHERECTOMY PROCEDURE TO TREAT PERIPHERAL VASCULAR DISEASE. THE CATHETER WAS OPENED AND PRIMED AS USUAL. THE CATHETER WAS INTRODUCED INTO THE ARTERY FOR ATHERECTOMY. UPON ACTIVATION, IT WAS NOTED THAT THERE WERE NO ASPIRATION CONTENTS. THE CATHETER WAS REMOVED AND RE-PRIMED. A SECOND ATTEMPT WAS MADE, BUT THE DEVICE STILL DID NOT ASPIRATE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS NOTED THAT ASPIRATION DIFFICULTIES AND TAKING TOO LONG TO PRIME HAVE BEEN ONGOING ISSUES WITH THIS CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900628 ↗
• MalfunctionSep 14, 2020Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS A LOSS OF ASPIRATION. A 2.1MM JETSTREAM XC CATHETER AND JETSTREAM CONSOLE WERE SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE LEFT LEG TIBIAL POPLITEAL TRUNK OVER A NON-BSC FILTER. THE MOTOR DRIVE UNIT SOUNDED LIKE IT WAS MAKING NOISE, HOWEVER, ASPIRATION WAS LOST. THE MOTOR DRIVE QUIT WORKING. WHEN THE CATHETER WAS REMOVED FROM THE BODY, THE EXTERIOR WAS OBSERVED TO BE KINKED AND ASPIRATION STOPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER JETSTREAM CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT DID WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529128 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JETSTREAM (B)(6) STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISTAL EMBOLIZATION IN THE TARGET LIMB. THE PATIENT WAS ENROLLED INTO THE JETSTREAM (B)(6) STUDY ON (B)(6) 2018 AND THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2018. THE 100% STENOSED, 5.0MMX60MM, TASC II B TARGET CLASSIFIED LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS TREATED WITH A 2.1 MM JETSTREAM XC ATHERECTOMY CATHETER AND A JETSTREAM CONSOLE. POST TREATMENT, PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY (PTA) WAS PERFORMED, WITH 10% FINAL RESIDUAL STENOSIS. ON (B)(6) 2018, A DISTAL EMBOLIZATION OF THE TARGET LIMB WAS DETECTED THROUGH ANGIOGRAPHY IN THE ANTERIOR TIBIAL ARTERY. THE EVENT WAS TREATED WITH THROMBUS ASPIRATION AND ENDOVASCULAR PTA. ON THE SAME DAY, THE SUBJECT WAS ALSO NOTED WITH CLASS B SUPERFICIAL FEMORAL ARTERY DISSECTION. NO ACTIONS WERE TAKEN TO TREAT THE EVENT. THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED. ON (B)(6) 2018, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

  Patient problems: Embolism; Vascular Dissection

  MAUDE report 10025216 ↗