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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939148308010
Device Problems Balloon; Torn Material
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the 3. 0 mm x 80 mm x 150 cm sterling¿ sl balloon was advanced to the superficial femoral artery and inflated twice. The distal portion of the balloon tore off while inside the patient. There was an attempt to remove the detached portion however it could not be recovered. The fragment was then pressed against the vessel wall with a stent where it remains inside the patient. The patient was reported to be doing fine.

 
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Brand NameSTERLING¿ SL
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key7441481
Report Number2134265-2018-03175
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device MODEL NumberH74939148308010
Device Catalogue Number39148-30801
Device LOT Number21454182
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/30/2017
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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