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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
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  malfunction  
Event Description
(b)(6) clinical study. It was reported that the balloon over extended during inflation. In (b)(6) 2020, the index procedure was performed. The target lesion was in the right peroneal artery with 99% stenosis, proximal and distal reference vessel diameter was 3. 25 mm and 3. 0 mm respectively with a length of 60 mm. As a treatment, orbital atherectomy was performed. Post atherectomy, balloon angioplasty was attempted with sterling balloon but there was significant 'watermelon seeding' of the irregular balloon. The balloon was withdrawn and the lesion was treated with a 4. 0 mm x 15 mm cutting balloon to pre-dilate the lesion at burst pressures with a 20% residual stenosis. Post pre-dilation, the lesion was further treated with placing a 3. 5 mm x 80 mm study stent. Post dilation was performed with residual stenosis of 0%.
 
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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
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10351162
MDR Text Key201526696
Report Number2134265-2020-10189
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received08/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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