• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100 CATHETER, PERIPHERAL, ATHERECTOMY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100 CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 04/09/2021
Event Type  Injury  
Event Description
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJETSTREAM PVCN100
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
150 baytech dr.
san jose CA 95134
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11924256
MDR Text Key253869960
Report Number2134265-2021-07154
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number45010
Device Catalogue Number45010
Device Lot NumberJET0464
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/02/2021 Patient Sequence Number: 1
-
-