Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Event Description
It was reported that the jetstream catheter was torn.A jetstream xc catheter, 2.1mm, was selected for use in an atherectomy procedure in the superficial femoral artery(sfa)/tibial peroneal trunk (tpt).During the procedure, when the device was through the tpt vessel, the outer sheath of the jetstream device tore.This tear caused fluid to spray out of the catheter and it was no longer able to be advanced.The device was removed.The procedure was completed via balloon angioplasty.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr:the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually and microscopically examined for any damage.Visual examination showed multiple catheter shaft damage in the form of buckling.The device showed a burst infusion sheath 18cm from the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
Event Description
It was reported that the jetstream catheter was torn.A jetstream xc catheter, 2.1mm, was selected for use in an atherectomy procedure in the superficial femoral artery(sfa)/tibial peroneal trunk (tpt).During the procedure, when the device was through the tpt vessel, the outer sheath of the jetstream device tore.This tear caused fluid to spray out of the catheter and it was no longer able to be advanced.The device was removed.The procedure was completed via balloon angioplasty.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JETSTREAM XC
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12164273
MDR Text Key261451378
Report Number2134265-2021-08869
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
Combination Product (y/n)N
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/23/2023
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0026848468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Date Manufacturer Received07/14/2021
Patient Sequence Number1
-
-