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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Vascular Dissection (3160)
Event Date 05/08/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter facility name: (b)(6).
 
Event Description
It was reported that a distal embolization and grade c dissection occurred. The patient was enrolled in the jetstream (b)(6) study with the patient identifier of (b)(6). As part of the study, the patient underwent treatment on (b)(6) 2019. The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion. The target lesion was treated with a jetstream pv atherectomy system console and a 2. 1mm jetstream xc atherectomy catheter and there was 40% residual stenosis. Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis. During the index procedure, distal embolization of the target lesion was noted. The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms. Post embolization, blood flow was slow. The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting. The embolization was considered recovered/resolved on the same day. Also during this procedure, a grade c dissection of the target lesion was noted post pta. No action was taken to treat this event. At the time of reporting, the event was recovering/ resolving. No further complications were reported.
 
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Brand NameJETSTREAM XC ATHERECTOMY CATHETER
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
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8667002
MDR Text Key146937123
Report Number2134265-2019-06307
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0021375755
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/04/2019 Patient Sequence Number: 1
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