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 Entrapment of Device (1212); Obstruction of Flow (2423); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2019
Event Type  malfunction  
Event Description
It was reported that the device clogged and ballooned up.A 2.1mm jetstream xc catheter was selected for use in an atherectomy procedure located in the superficial femoral artery.During the procedure, the device began to balloon up full of saline and rotaglide and became stuck in the sheath.The outer lumen, infusion lumen appeared to be clogged.The device was cut and removed with the non-bsc 7f sheath.A new sheath was used to complete the procedure.There were no patient complications reported and the patient's status is fine.
 
Event Description
It was reported that the device clogged and ballooned up.A 2.1mm jetstream xc catheter was selected for use in an atherectomy procedure located in the superficial femoral artery.During the procedure, the device began to balloon up full of saline and rotaglide and became stuck in the sheath.The outer lumen, infusion lumen appeared to be clogged.The device was cut and removed with the non-bsc 7f sheath.A new sheath was used to complete the procedure.There were no patient complications reported and the patient's status is fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter stuck in an introducer sheath.Visual examination showed that there was severe shaft damage in the form of kinks and buckling from the tip proximally to 61cm.The device was separated approximately 27.5c from the tip.Visual examination noticed that the infusion line had burst proximal of the introducer sheath.The location of the burst infusion line was approximately 59cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
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 Key8273795
MDR Text Key133966673
Report Number2134265-2019-00296
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
Combination Product (y/n)N
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/30/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022587572
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Date Manufacturer Received01/30/2019
Patient Sequence Number1
Treatment
SHEATH: TERUMO PINNACLE 7F; SHEATH: TERUMO PINNACLE 7F; SHEATH: TERUMO PINNACLE 7F
-
-