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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 7313
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
Returned product consisted of a nc emerge balloon catheter. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Visual examination revealed no damages. Microscopic examination revealed a longitudinal tear in the balloon 10. 5mm from the tip and approximately 7mm long. There is blood present in the inflation lumen and balloon. The balloon is loosely folded. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.
 
Event Description
Reportable based on device analysis completed on 18-dec-2018. It was reported that crossing difficulties were encountered. The 90% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery. A 3. 00mm x 15mm nc eemerge balloon catheter was advanced but failed to cross the lesion. The device was removed and the procedure was completed with another of the same device. No patient complications were reported. However, returned device analysis revealed balloon rupture.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8233303
MDR Text Key132591353
Report Number2134265-2018-64962
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2020
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0021687898
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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