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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 H74939032602210
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 06/06/2018
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: the complaint device was not received for analysis. The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling. (b)(4).
 
Event Description
(b)(6) study. It was reported that dissection occurred. In (b)(6) 2018, the subject¿s qualifying condition as rutherford category 2. In (b)(6) 2018 the index procedure was performed. Target lesion #1 was located in the right superficial femoral artery (sfa) had 99% stenosis, reference vessel diameter of 6 mm, a length of 110 mm, and tasc ii lesion classification was unknown. Target lesion #1 was treated with pre-dilatation using 6 mm x 220 mm balloon and standard percutaneous transluminal angioplasty (pta) was performed with 6 mm x 220 mm sterling¿ balloon. Post- dilatation was performed using 6 mm x 220 mm balloon and following this, a grade 'd' dissection was noted. Grade d dissection was treated with bare metal stent bailout. The event was considered recovered/resolved.
 
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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 Key7647970
MDR Text Key112699479
Report Number2134265-2018-05728
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Model NumberH74939032602210
Device Catalogue Number39032-60221
Device Lot Number22078445
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 Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/28/2018 Patient Sequence Number: 1
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