• 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 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 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493919315350
Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 01/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of an emerge balloon catheter with an unidentified stopcock attached to the hub. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The device was hooked up to an inflation device containing water and the device leaked water from the shaft at the exit notch. There is damage and a puncture hole in the shaft at the exit notch causing the device to leak at that location. The damage at the exit notch is consistent with damage that is caused by the guidewire. 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. The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event. (b)(4).
 
Event Description
It was reported that shaft leak occurred. During preparation of a 3. 50mm x 15mm emerge¿ balloon catheter, leakage of contrast media occurred near the exit port of the guide wire. It appeared that there was a hole on the device. The procedure was completed with a non-bsc balloon catheter. No patient complications nor injuries were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEMERGE¿
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 Key7277903
MDR Text Key100513005
Report Number2134265-2018-00922
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K113220
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 01/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/08/2020
Device Model NumberH7493919315350
Device Catalogue Number39193-1535
Device Lot Number21117568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-