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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926712300
Device Problems Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that balloon rupture and balloon detachment occurred. The 90% stenosed target lesion was located in the semi tortuous and highly calcified second diagonal branch of the left anterior descending artery (lad). A 2. 5x12mm nc emerge® balloon catheter was advanced for dilatation. However, the balloon was not able to get adequate plaque compression even at full inflation. The device was replaced with a 3. 00mm x 12mm nc emerge® balloon catheter. During inflation at 10 atmospheres, the balloon ruptured and was snagged in the plaque and blood was noted in the indeflator. Multiple techniques with different wires were used to remove the device and when the device was removed, it was noted that the delivery system become stretched, and the balloon itself got detached and remained in the artery. What remained of the delivery system was removed. It was apparent under fluoroscopy that there were radiopaque marker bands remaining inside the patient. The patient was then sent for coronary artery bypass graft and the remaining balloon catheter was removed. No further patient complications were reported and the patient's status was stable.
 
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Brand NameNC EMERGE®
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7341814
MDR Text Key102599674
Report Number2134265-2018-01823
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 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493926712300
Device Catalogue Number39267-1230
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 Received02/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/15/2018 Patient Sequence Number: 1
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