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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Thrombosis (2100)
Event Date 05/17/2019
Event Type  Injury  
Event Description
It was reported that thrombosis and chest pain occurred. The 90% stenosed target lesion was located in the very calcified and moderately tortuous left anterior descending artery (lad). The length was about 23mm. The vessel size was approximately 25mm in diameter and the patient was referred for an atherectomy where a non bsc device was used. After the atherectomy was done, a 10 mm x 2. 50 mm wolverine coronary cutting balloon was advanced to dilate the proximal lad and was inflated twice for 15 seconds at nominal pressure and resulted in a timi 3 flow. A 2. 50 x 24 synergy stent was advanced and implanted in the proximal lad. A timi 3 flow resulted after the case and everything was open. The patient was taken off the table and approximately 30 minutes later, the patient was having chest pain. The patient was brought back to the cath lab and a thrombus distal to the stent was noticed. A balloon device was used to inflate this area, and the patient was given heparin to get the activated clotting time (act) up above 300. An aspiration catheter was used and pumped up and resulted in timi 3 flow again. The patient was stable and doing fine. The act that was achieved during the procedure was 285, and preventative was given as well in a mini loading dose. After the procedure, a non bsc guidewire was used to gain access to the vessel. A non bsc guidewire was also used to gain access and later switched to a non bsc guidewire. A non bsc guidewire had been used during the procedure and at the start of the procedure. Then when the patient was brought back, another non bsc guidewire was used. The original device, a 2. 50 x 24 synergy stent, was used in the first procedure and this was implanted. A lone stent was implanted in the first part of the procedure. Once they got an optimal result, everything was pulled out and the patient was removed off the table. After the thrombus, a 2. 5 mm x 15 mm emerge balloon was advanced to dilate the target lesion and inflated once at nominal pressure for 10 seconds. The procedure was completed with a different device. No patient complications were reported and the patient condition post procedure was good.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, 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 Key8684274
MDR Text Key147501427
Report Number2134265-2019-06648
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
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 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/12/2021
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0023499527
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 Received05/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2019
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: 06/10/2019 Patient Sequence Number: 1
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