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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE MONORAIL PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION EMERGE MONORAIL PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number H7493918912200
Device Problem Break (1069)
Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Ischemia (1942); Myocardial Infarction (1969)
Event Date 05/10/2021
Event Type  Injury  
Event Description
Pertains to boston scientific emerge monorail ptca dilatation catheter; size 2. 00 mm x 2 mm, lot #26896533. The hyper tube broke and came out. The balloon stayed in. This occurred during percutaneous coronary intervention of the left circumflex artery. He was recently admitted to another hospital for non-st elevation myocardial infarction. His creatinine was also somewhat worsened than his baseline. He has history of chronic kidney disease. Hence we decided to perform a stress test as outpatient. He underwent stress test which showed inferolateral infarct and peri-infarct ischemia along with small area of anteroseptal ischemia. Despite his ischemic cardiomyopathy is ef surprisingly was noted to be normal on the nuclear stress test. He continued though having symptoms where he was having severe shortness of breath on exertion or persistent fatigue and of-and-on chest pain. Considering the fact that he was fairly well aware of his symptoms and variation in his symptoms he essentially made the decision for himself that he probably needed a cardiac catheterization because he was reaching a point where the medication management was not really helping him any further. Hence we decided to proceed with cardiac catheterization.
 
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Brand NameEMERGE MONORAIL PTCA DILATATION CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11862317
MDR Text Key252312094
Report NumberMW5101476
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberH7493918912200
Device Lot Number26896533
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/20/2021 Patient Sequence Number: 1
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