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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74934358780
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 03/07/2018
Event Type  Death  
Manufacturer Narrative
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
Same case as mdr id#: 2134265-2018-02521, 2134265-2018-02522, 2134265-2018-02525, 2134265-2018-02523 and 2134265-2018-02530. It was reported that the patient died. The 90% stenosed target lesion was located in the left circumflex artery. After an 8f mach1 guide catheter was advanced, a 1. 50mm peripheral rotalink® plus and a 330cm rotawire were advanced for ablation. However, during the procedure, it was noted that the burr became stuck in the plaque of the artery. Intracardiac nitroglycerin was then administered and the vessel was rewired. Subsequently, dilatations were performed with a 1. 20mm x 12mm, 2. 00mm x 20mm, and 2. 5mm x 15mm emerge¿ balloon catheters to facilitate removal of the burr but were unsuccessful. The physician decided to perform coronary artery bypass graft on the patient and the burr was successfully removed. The patient was then transferred to the intensive care unit; however, 1 hour and 26 minutes later, the patient died.
 
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Brand NameMACH1 GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer (Section G)
AVAIL MEDICAL PRODUCTS INCORPORATED
5950 nancy ridge drive
san diego CA 92121
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7389378
MDR Text Key104083854
Report Number2134265-2018-02531
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020028
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 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Model NumberH74934358780
Device Catalogue Number34358-78
Device Lot Number0060072069
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 Received03/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2017
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: 04/02/2018 Patient Sequence Number: 1
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