• 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 ATHERECTOMY CATHETER 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 ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problem Suction Problem (2170)
Patient Problem Vasoconstriction (2126)
Event Date 05/27/2020
Event Type  Injury  
Event Description
It was reported that the patient experienced numerous spasms. A 2. 1mm jetstream xc atherectomy catheter was selected for use. After three minutes of normal use, the catheter locked and there was a loss of aspiration. The patient experienced numerous spasms. The procedure was completed with another of the same device. The patient's status post procedure was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJETSTREAM XC ATHERECTOMY CATHETER
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 Key10167921
MDR Text Key195570328
Report Number2134265-2020-08168
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/06/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0024219581
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2019
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: 06/18/2020 Patient Sequence Number: 1
-
-