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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 H74939031402010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Death (1802); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Date 11/27/2017
Event Type  Death  
Manufacturer Narrative

Death date and event date: (b)(6) 2017. Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that patient death occurred. The target lesion was located in a stenosed left carotid artery. The 4. 00x20 mm sterling monorail balloon was inserted and inflated according to the directions for use for two seconds. No problems were noted. The patient experienced self-limiting bradycardia followed by hypertension which could not be managed by anesthesia. The patient subsequently died.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was further reported that non-compensable hypotension occurred during the days following the procedure and that the patient died four days later.

 
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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 Key7168405
MDR Text Key96508452
Report Number2134265-2017-12909
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK053118
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/20/2020
Device MODEL NumberH74939031402010
Device Catalogue Number39031-40201
Device LOT Number20795780
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 Received02/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/23/2017
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: 01/05/2018 Patient Sequence Number: 1
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