• 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 XC 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 XC CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 10/31/2019
Event Type  Injury  
Manufacturer Narrative
Patient identifier: (b)(6).
 
Event Description
It was reported that distal emboli occurred. The subject was enrolled into the (b)(6) clinical study on (b)(6) 2019 and the index procedure was performed on the same day. The target lesion, located in the right mid superficial femoral artery (sfa), has 90% stenosis, a reference vessel diameter of 5. 0 mm, and a length of 130mm. It was classified as a tasc ii b lesion. The target lesion was treated with balloon angioplasty followed by debulking using a jetstream xc 2. 4 / 3. 4 mm catheter, with 25% residual stenosis. Post-treatment, percutaneous transluminal balloon angioplasty was performed with optimal size balloon, with 25% residual stenosis. Following this, percutaneous transluminal balloon angioplasty (pta) with drug-coated balloon was performed resulting in 25% final stenosis. On the same day as the index procedure, distal emboli of the target limb into the right anterior tibial artery was noted. Aspiration and plain old balloon angioplasty (poba) was performed as treatment. The event was considered recovered/resolved. On (b)(6) 2019, the subject was discharged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJETSTREAM XC
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9554186
MDR Text Key173967581
Report Number2134265-2019-16372
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133023
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 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/11/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0023070753
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 Received12/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2020 Patient Sequence Number: 1
-
-