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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 7214
Device Problems Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/21/2020
Event Type  Injury  
Event Description
It was reported that balloon rupture, balloon detachment and shaft break occurred. The target lesion was located in the severely calcified left anterior descending artery. A 3. 00mm x 20mm nc emerge balloon catheter was advanced for dilatation. However, during inflation at 24 atmospheres, the balloon ruptured. As the physician pulled the balloon back, the balloon material hung up on the stent and came off the shaft. The tip of the catheter with the distal marker were still attached to the balloon. A non-bsc balloon was advanced and pushed the balloon fragment in the tip of the catheter. The physician went back down with another synergy stent and deployed it to trap the balloon material and the tip of the catheter up against the other stent and the vessel wall. Post dilatation was performed again with a non-bsc balloon catheter and completed the procedure. No patient complications were reported and the patient did well and was okay.
 
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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 Key9837108
MDR Text Key183727065
Report Number2134265-2020-02831
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 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/03/2022
Device Model Number7214
Device Catalogue Number7214
Device Lot Number0024987041
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 Received02/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2020
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: 03/16/2020 Patient Sequence Number: 1
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