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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 7163
Device Problem Deflation Problem (1149)
Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Vascular Dissection (3160)
Event Date 07/31/2021
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that balloon deflation failure and subsequent patient complications occurred. Vascular access was obtained via the radial artery. The 90% tightly stenosed, 3x30mm, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending (lad) artery. A 2. 50mm x 15mm emerge balloon catheter was advanced for pre-dilation. On the first inflation, the balloon was slowly inflating up to 12 atmospheres. However, after the second inflation, the balloon was not able to deflate even after using a different inflation/deflation device. The patient went into ventricular tachycardia and was in a critical situation. The patient also experienced st elevation myocardial infarction. A deep intubation of the catheter was performed and the device was removed together with the guide catheter and the wire. The angiography showed a dissection of the medium lad. When the procedure was completed, there were two stents implanted in the lad. No further patient complications were reported.
 
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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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12310922
MDR Text Key266161993
Report Number2134265-2021-10145
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeMO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0027226619
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 Received08/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2021
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: 08/11/2021 Patient Sequence Number: 1
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