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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reocclusion (1985)
Event Date 09/05/2018
Event Type  Injury  
Event Description
(b)(6) study. It was reported that restenosis occurred. In (b)(6) 2018, clinical status assessment identified the patient's qualifying condition as rutherford category 3. Subsequently, the index procedure was performed. The target lesion was located in the left superficial femoral artery (sfa) had 100% stenosis, reference vessel diameter of 5mm, a length of 100mm and was classified as a tasc ii a lesion. The target lesion was treated with pre-dilatation using 4mm x 150mm balloon. Post pre-dilatation, standard percutaneous transluminal angioplasty (pta) was performed with 5mm x 150mm sterling balloon to the target lesion. Following, grade a dissection was noted; however, no action was taken. Post dilatation was also performed. The patient was discharged as an outpatient. In (b)(6) 2018, the patient developed restenosis in the left sfa. No action was taken to treat the event.
 
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Brand NameSTERLING
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8232669
MDR Text Key132567196
Report Number2134265-2018-64891
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 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/05/2019
Device Model Number24715
Device Catalogue Number24715
Device Lot Number0021840677
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 Received12/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2018
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: 01/09/2019 Patient Sequence Number: 1
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