• 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 Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem Embolism (1829)
Event Date 08/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that distal embolization occurred. A 2. 4mm jetstream xc catheter was selected for an atherectomy and angioplasty procedure to treat in-stent restenosis of the superficial femoral artery (sfa). During the procedure, the physician noted the jetstream had difficulty tracking over a non-bsc guidewire. It resulted in the jetstream becoming difficult to advance and remove. Additionally, a non-bsc filterwire became displaced from its original position. It was not clear to the physician whether this related to non-bsc guidewire movement issues. The guidewire was ultimately replaced with a thruway guidewire due to a kink. Replacement with a new wire resulted in distal embolization in the below-the-knee vessels. This left the patient with one vessel run off instead of two. The physician tried to remove the distal embolization with the jetstream but otherwise left it. It was felt that running the jetstream over the thruway wire without a filter caused the distal embolization. The case was successfully completed. At no point did the wires bind to the jetstream catheter permanently or require advanced attempts to disconnect the two. However, treatment time was reduced to avoid any more serious issues. The total run-time was 16m48s and at no point did the catheter sit in the one position for an excessive amount of time. The patient status post-procedure was reported as 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
cork IRELA ND
EI IRELAND
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8965815
MDR Text Key156656269
Report Number2134265-2019-10672
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeAS
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 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/09/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0023771174
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 Received08/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2019
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: 09/05/2019 Patient Sequence Number: 1
Treatment
ABBOTT BAREWIRE; ABBOTT NAV6 FILTERWIRE; THRUWAY GUIDEWIRE
-
-