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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 H7493926712350
Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2019
Event Type  Injury  
Event Description
A 6 french xb lad 3. 5 guide was engaged in the ostium of the left main artery. A 3. 5 x 12 mm nc emerge mr balloon was prepped and advanced across the proximal lad, then inflated to 12 atm in 21 seconds. Thirty seconds later, the distal end of the balloon shaft broke off, which left the balloon in the proximal left anterior descending (lad). At this point, the patient did describe chest pain, but did not have any st-t wave abnormalities or hemodynamic issues. The doctor advanced a long run wire into the apical lad. Ten minutes later, another compliant balloon was advanced into the proximal lad, inflated to 5 atm and used to trap the broken balloon and pull it back into the guide catheter. At that point, both balloons were safely removed from the patient. The balloon was not inflated to or above its rated burst pressure at any point (20 atm). The operator applied an even, smooth amount of pressure as to not force a kink of the catheter. The fact that the non-compliant balloon dilatation catheter failed, so catastrophically as to fragment and leave a segment behind is unacceptable. Fortunately, the interventional cardiologist/fellow was able to successfully retrieve all of the pieces of the balloon catheter shaft fracture and no harm was caused to the patient.
 
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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
MDR Report Key8695369
MDR Text Key147909635
Report Number8695369
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/31/2019,05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493926712350
Device Catalogue NumberH7493926712350
Device Lot Number23287834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/31/2019
Event Location Hospital
Date Report to Manufacturer06/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/13/2019 Patient Sequence Number: 1
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