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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493912412300
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 08/17/2017
Event Type  Death  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr# 2134265-2017-08879, 2134265-2017-08878, and 2134265-2017-08942. It was reported that hypotension, bradycardia, cardiac arrest and death occurred. Vascular access was obtained via the femoral artery. The 95% stenosed, 18mm x 3mm, concentric, denovo, target lesion was located in a non tortuous, severely calcified mid left anterior descending artery (lad). Following rotablation with a 1. 50mm rotalink¿ plus there was slow flow. Medication was administered and timi-3 restored. The lesion was successfully stented with a 3. 00x28mm promus element¿ plus. A 12x3. 00mm nc quantum apex¿ balloon catheter and a 2. 00x12mm maverick²¿ balloon catheter were used during the procedure. The patient was moved to the intensive care unit and while there developed hypotension followed by bradycardia. The patient went into cardiac arrest and died.
 
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Brand NameNC QUANTUM APEX¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, 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 Key6845621
MDR Text Key85004582
Report Number2134265-2017-08948
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Model NumberH7493912412300
Device Catalogue Number39124-1230
Device Lot Number19452922
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 Received08/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2016
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: 09/06/2017 Patient Sequence Number: 1
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