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 7133
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2019
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 3.00mm x 15mm emerge balloon catheter was selected for use.However, the device broke while introducing it in the guide catheter.There were no patient complications reported.No further information available.
 
Event Description
It was reported that shaft break occurred.A 3.00mm x 15mm emerge balloon catheter was selected for use.However, the device broke while introducing it in the guide catheter.There were no patient complications reported.No further information available.
 
Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of an emerge balloon catheter.The balloon was tightly folded.Microscopic examination revealed that the hypotube had numerous kinks.There were no separations identified.The reported separation was not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9455568
MDR Text Key176241029
Report Number2134265-2019-15604
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806233
UDI-Public08714729806233
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,foreig
Type of Report Initial,Followup
Report Date 01/28/2020
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
Device Operator Health Professional
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0024185650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Initial Date Manufacturer Received 12/03/2019
Initial Date FDA Received12/11/2019
Supplement Dates Manufacturer Received01/09/2020
Supplement Dates FDA Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-