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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939031601610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Embolism (1829)
Event Date 07/03/2017
Event Type  Injury  
Manufacturer Narrative
The complaint device was not returned for analysis. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
(b)(4) clinical study. It was reported that vessel dissection and embolism occurred. In (b)(6) 2017, the index procedure was performed. The 100% stenosed, 95mm long with a reference vessel diameter of 6. 5mm, and classified as a tasc ii b target lesion was located in the left superficial femoral artery (sfa). The lesion was treated with pre-dilatation using 5 mm x 100 mm balloon and standard percutaneous transluminal angioplasty with a 6. 0mmx150mmx150cm (4f) sterling¿ balloon catheter. Following this intervention, a grade b dissection was noted which was treated with balloon dilatation. Post dilatation was also performed. Furthermore, embolism was noted in the left peroneal artery and posterior artery. This complication was treated with thrombus aspiration and balloon dilatation. On the same day, the event was considered to be resolved and the patient was discharged with cilostazol and clopidogrel.
 
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Brand NameSTERLING¿
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6970886
MDR Text Key90027083
Report Number2134265-2017-10337
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K141150
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 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Model NumberH74939031601610
Device Catalogue Number39031-60161
Device Lot Number19232883
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 Received10/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
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: 10/24/2017 Patient Sequence Number: 1
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