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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 Material Rupture (1546)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pain (1994)
Event Date 02/14/2022
Event Type  Injury  
Event Description
It was reported that balloon rupture occurred; the patient experienced bradycardia, decreased blood pressure, and pain. The patient underwent vascular dilatation by intervention. The 95% stenosed target lesion was located in the mildly tortuous and severely calcified proximal, mid and distal right coronary artery. A 2. 50mm x 15mm emerge balloon catheter was advanced for dilatation and was inflated at 14 atmospheres. It was noted that the balloon burst due to severe calcification. The physician found a circular, with no image in the middle and distal segment of the patient's blood vessels, the patient suddenly developed a slowed heart rate, decreased blood pressure, pain, and moaning/groaning symptoms. Atropine, epinephrine, dopamine, morphine injection and other intravenous injections were given immediately to the patient. No further patient complications were reported and the patient was stable.
 
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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 Key13725881
MDR Text Key287112392
Report Number2134265-2022-02255
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0027557373
Was Device Available for Evaluation? No
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2021
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: 03/10/2022 Patient Sequence Number: 1
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