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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7313
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Ischemia (1942); Myocardial Infarction (1969); Pulmonary Edema (2020); Tachycardia (2095)
Event Date 11/11/2021
Event Type  Death  
Event Description
It was reported that patient death occurred. A live broadcast of a high risk percutaneous coronary intervention, with a culotte technique approach, was performed on a bifurcated lesion located in the left main, left circumflex, and ostial marginal artery. The patient was noted to have presented to the case in poor condition, with a history of diabetes. 035/180/3mm amplatz guidewire, 2. 00mm x 15mm emerge balloon, two 2. 50mm x 15mm emerge balloons, 4. 00mm x 12mm emerge balloon, 2. 25mm x 12mm emerge balloon, 4. 00mm x 6mm emerge balloon, 2. 25 x 16 synergy stent, 3. 00 x 16 synergy stent, 2. 25 x 28 synergy stent, 2. 00 mm x 20. 00 mm agent dcb, and opticross hd vascular imaging were used to treat the patient. It was noted that the stents were deployed and no issues with any of the devices occurred. Following treatment with the devices, the patients condition descending rapidly due to the intervention, but was noted to not be considered device related. The patient went into pulmonary edema, was intubated, and then ultimately passed away.
 
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Brand NameNC EMERGE
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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12924918
MDR Text Key281674779
Report Number2134265-2021-15298
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0027858758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2021
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: 12/03/2021 Patient Sequence Number: 1
Treatment
035/180/3MM AMPLATZ GUIDEWIRE-BSC; 2.00 MM X 20.00MM AGENT DCB MR-BSC; 2.00MM X 15MM EMERGE BALLOON-BSC; 2.25 X 16 SYNERGY STENT-BSC; 2.25 X 28 SYNERGY STENT-BSC; 2.25MM X 12MM NC EMERGE BALLOON-BSC; 2.50MM X 15MM NC EMERGE BALLOON-BSC; 3.00 X 16 SYNERGY STENT-BSC; 4.00MM X 12MM NC EMERGE BALLOON-BSC; 4.00MM X 6MM NC EMERGE BALLOON-BSC; OPTICROSS HD-BSC
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