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 Mechanical Problem (1384); Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
Device eval by manufacturer: the jetstream device xc-2.1 was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed multiple slight bends throughout the length of the shaft.The device showed a buckled/kinked area located 90.5cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use.The device primed as designed.There were no issues with running the device.The device activated and was run for a period of 2 minutes in the blades up and down modes.No errors were noticed on the console.The waste bag was returned with blood inside.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was not consistent with the reported information.
 
Event Description
It was reported that the device stopped rotating and aspirating.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery.While debulking the 250mm segment, the device stopped working after approximately 5 seconds of use.The device was removed.The procedure was completed with another jetstream xc catheter.No patient complications were reported and the patient had a great outcome.
 
Event Description
It was reported that the device stopped rotating and aspirating.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery.While debulking the 250mm segment, the device stopped working after approximately 5 seconds of use.The device was removed.The procedure was completed with another jetstream xc catheter.No patient complications were reported and the patient had a great outcome.
 
Manufacturer Narrative
Updated device eval by manufacturer: the jetstream device xc-2.1 was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed multiple slight bends throughout the length of the shaft.The device showed a buckled/kinked area located 90.5cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use.The device primed as designed.There were no issues with running the device.The device activated and was run for a period of 2 minutes in the blades up and down modes.No errors were noticed on the console.The waste bag was returned with blood inside.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was not consistent with the reported information.Aspiration testing of the device was done per the test procedure.Test results showed that this device did perform per specification withdrawing 42ml of fluid in the 1minute time frame.Inspection of the remainder of the device, revealed no 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 Key10195487
MDR Text Key196444807
Report Number2134265-2020-08490
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 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2022
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0025296106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2020
Date Manufacturer Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
-
-