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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100 CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100 CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45010
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).
 
Event Description
Jetstream (b)(6) study. It was reported that the patient experienced a distal embolization in the target limb. The patient was enrolled into the jetstream (b)(6) study on (b)(6) 2018 and the index procedure was performed on (b)(6) 2018. The 100% stenosed, 5. 0mmx60mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery (sfa). The lesion was treated with a 2. 1 mm jetstream xc atherectomy catheter and a jetstream console. Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 10% final residual stenosis. On (b)(6) 2018, a distal embolization of the target limb was detected through angiography in the anterior tibial artery. The event was treated with thrombus aspiration and endovascular pta. On the same day, the subject was also noted with class b superficial femoral artery dissection. No actions were taken to treat the event. The event was considered to be recovered/resolved. On (b)(6) 2018, the subject was discharged on aspirin and clopidogrel.
 
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Brand NameJETSTREAM PVCN100
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
150 baytech dr.
san jose CA 95134
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10025216
MDR Text Key190111213
Report Number2134265-2020-05990
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
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number45010
Device Catalogue Number45010
Device Lot NumberJET0552
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 Received04/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/05/2020 Patient Sequence Number: 1
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