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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 7213
Device Problem Deflation Problem (1149)
Patient Problem Bradycardia (1751)
Event Date 06/21/2020
Event Type  Injury  
Event Description
It was reported that balloon deflation issue occurred and patient experienced bradycardia. The target lesion was located in the left anterior descending artery (lad). A 2. 50mm x 15mm nc emerge balloon catheter was advanced and initially inflated at 8 atmospheres for 15 seconds with a non-bsc inflation device. However, during the second inflation at 6 atmospheres for 10 seconds, the balloon failed to deflate. A second non-bsc inflation device was used to deflate the balloon. The prolonged inflation cut off blood to the distal portion of the lad and the patient experienced symptomatic bradycardia. Subsequently, the patient was treated with emergency medications and cardiopulmonary resuscitation. After the patient was stabilized, the procedure was completed with stent placement in the lad. No further patient complications were reported and the patient recovered.
 
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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 Key10260876
MDR Text Key198493212
Report Number2134265-2020-08696
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
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 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0025403980
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 Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2020
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: 07/10/2020 Patient Sequence Number: 1
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