Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 CORPORATION 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 CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7143
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/18/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the obtuse marginal artery.A 2.50mm x 15mm emerge balloon catheter was advanced for treatment.However, the device got stuck on the wire and was unable to be removed separately.Both devices were removed together, the balloon with the wire stuck inside.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EMERGE
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10649688
Report Number2134265-2020-13439
Device Sequence Number11592223
Product Code LOX
UDI-Device Identifier08714729806820
UDI-Public08714729806820
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K113220
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/03/2021
Device Model Number7143
Device Catalogue Number7143
Device Lot Number0024371517
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/21/2020
Initial Report FDA Received Date10/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE: 300CM BMW
-
-