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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 H7493926708350
Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Returned product consisted of a nc emerge balloon catheter in two pieces along with 2 unidentified y-adapters and an unidentified 7f guide catheter. The balloon was loosely folded with blood in the guidewire lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. The outer shaft is torn/separated 140. 9cm from the hub and the inner shaft is torn/separated 2mm from the exit notch. The fractured/separated ends of the shafts are stretched and jagged which indicates the shaft separation was due to tensile forces. There are numerous hypotube and shaft kinks. The tip and balloon have been torn off/separated and were not returned for analysis. The distal inner shaft is buckled and stretched in numerous locations. There was no evidence of any material or manufacturing deficiencies contributing to the confirmed damage or event. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
Same case as mdr id 2134265-2018-05363. It was reported that balloon rupture and detachment occurred. The chronic totally occluded target lesion was located in the right coronary artery. A 3. 50mm x 8mm nc emerge® balloon catheter was advanced for dilation. However, during the procedure, the balloon ruptured in the artery. Upon removal of the device, it was believed that the balloon snagged on the 7f guidezilla¿ ii guide extension catheter. The balloon then detached from the shaft of the balloon. The balloon was completely removed by pulling the guide wire and guidezilla. Then aspiration was performed to remove the balloon fragments. No damage was noted on the guidezilla. The procedure was then completed with new emerge balloons and synergy stents. No further patient complications were reported and the patient's status was good.
 
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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 Key7602164
MDR Text Key111083814
Report Number2134265-2018-05362
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 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/03/2020
Device Model NumberH7493926708350
Device Catalogue Number39267-0835
Device Lot Number0021945196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2018
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: 06/14/2018 Patient Sequence Number: 1
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