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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 06/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Jetstream (b)(6) study. It was reported that the patient experienced a distal embolization in the target limb. The 100% stenosed, 5. 0mmx60mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery. The lesion was treated with a 2. 1 mm jetstream xc atherectomy catheter. A distal embolization of the target limb was detected through angiography in the anterior tibial artery. Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 10% final residual stenosis. The event was treated with the help of thrombus aspiration and pta. The subject was discharged.
 
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Brand NameJETSTREAM XC ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
model farm road
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 Key7710999
MDR Text Key114730111
Report Number2134265-2018-06528
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,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
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: 07/23/2018 Patient Sequence Number: 1
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