• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493927615250
Device Problems Bent (1059); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4).   device evaluated by mfr. : returned product consisted of a nc emerge balloon catheter. The balloon was loosely folded with blood in the inflation lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. The balloon has a pinhole at the distal markerband. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty, which could not be confirmed because the clinical circumstances could not be replicated. 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
Reportable based on device analysis completed on 22-jan-2018. It was reported that crossing difficulties were encountered and tip damage occurred. The 85% stenosed target lesion was located in the mid left anterior descending artery. A 2. 50mm x 15mm nc emerge® balloon catheter was advanced but failed to cross the lesion and the tip was damaged. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed a balloon pinhole.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7271298
MDR Text Key100134978
Report Number2134265-2018-00765
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/11/2019
Device Model NumberH7493927615250
Device Catalogue Number39276-1525
Device Lot Number21240832
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-