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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: older than 18 years. Patient's year of birth reported as (b)(6). Device evaluated by mfr: visual analysis of the returned device revealed damage at the tip area of the device and the tip was pulled away from the catheter shaft. The infusion line appeared to be buckled. There were also some very small buckling/kinked areas located from 17cm proximally all the way to the tip. The observed damage was consistent with damage seen while pushing, pulling and torqueing of the device in a tortuous anatomy or a heavily calcified lesion. Functional analysis revealed the device primed and ran as designed. There was no evidence of a manufacturing issue. Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
Reportable based on analysis completed 03-may-2019. It was reported that the device could not advance. A 2. 4mm jetstream xc catheter was selected for use. During procedure the device was advancing, however, there was difficulty in the bifurcation and the catheter would not turn. The catheter was then removed and the procedure was completed using a non-bsc device. There were no patient complications reported. However, analysis revealed the tip was separated from the catheter shaft.
 
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Brand NameJETSTREAM XC
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road,
cork
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8632318
MDR Text Key145784818
Report Number2134265-2019-05584
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/15/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022256569
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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