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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 Problems Break (1069); Leak/Splash (1354); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2019
Event Type  malfunction  
Event Description
It was reported that the jetstream filled up with fluid and ruptured. A 2. 1mm jetstream catheter was selected for an arthrectomy procedure in the superficial femoral artery (sfa). During the procedure, the catheter was introduced by doralis pedis approach through a 6/7f slender sheath pedal retrograde approach through the anterior tibial. The device was introduced and the plan was to treat the sfa. The device went smooth up to the sfa. The device was turned on and was advancing easily but then would not advance anymore. The rpms were steady in the 70s and audible pitch was good and steady as the physician continued to push. Fluid was building up and a bubble was forming outside the shaft of the catheter at the hub of the sheath. The jetstream filled with fluid and ruptured. The device was removed and the arthrectomy was aborted. There were no patient complications and the patient was fine.
 
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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 Key8256940
MDR Text Key133355272
Report Number2134265-2019-00108
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,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0020297933
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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