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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 Problem Vascular Dissection (3160)
Event Date 03/06/2019
Event Type  Injury  
Event Description
It was reported that a type b dissection occurred. The patient was enrolled into the jetstream china study on (b)(6) 2019. The target lesion located in the left mid superficial femoral artery (sfa) had 100% occlusion, reference vessel diameter of 5mm, and length of 112mm and was classified as tasc ii b lesion. The target lesion was treated with sc 1. 8mm and xc 2. 1/3. 0mm jetstream catheters. Post treatment, percutaneous transluminal ballon angioplasty (pta) was performed, with 20% final residual stenosis. On (b)(6) 2019, same day of the index procedure, post jetstream treatment with the xc 2. 1/3. 0mm catheter, a type b dissection was noted in the target lesion. Interventional procedure was performed to treat the event. On the same day, the event was considered to be recovered/resolved.
 
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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
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8469577
MDR Text Key140484496
Report Number2134265-2019-02604
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
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 Received04/01/2019
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2019 Patient Sequence Number: 1
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