• 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 - CORK 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 - CORK JETSTREAM® XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 112264-001
Device Problems Crack (1135); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. Returned product consisted of a jetstream xc-2. 1 atherectomy catheter in one piece. The device was checked for any damage or leaking issues. During functional testing, it showed a leak from the infusion side of the baton. Closer examination showed evidence that the device was improperly inserted into the console and the door was shut and cracked the tubing when force was applied to try and close the door completely. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. Bsc id # (b)(4) / tw # (b)(4).
 
Event Description
It was reported the device was cracked and there was air within the device. A 2. 1mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure. During preparation outside the patient, it was observed that there was a lot of air in the device. Once the device was removed, it was noticed that the roller tubing was cracked. The device never went inside the patient. The procedure was completed with a different device. There were no patient complications and the patient was fine.
 
Manufacturer Narrative
(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported the device was cracked and there was air within the device. A 2. 1mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure. During preparation outside the patient, it was observed that there was a lot of air in the device. Once the device was removed, it was noticed that the roller tubing was cracked. The device never went inside the patient. The procedure was completed with a different device. There were no patient complications and the patient was fine.
 
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 - CORK
business and technology park
model farm road
cork
EI
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6667124
MDR Text Key205897630
Report Number2134265-2017-06579
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model Number112264-001
Device Catalogue NumberPV31300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-