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

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS SOFT86 INSERTS

  • 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
 

EDWARDS LIFESCIENCES DR FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS SOFT86 INSERTS Back to Search Results
Model Number SOFT86
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aortic Dissection (2491)
Event Date 01/16/2017
Event Type  Injury  
Manufacturer Narrative
The products are not available for evaluation as they were discarded at the facility. Without the return of the products, it is not possible to determine if damages or defects existed on the products. The lot numbers was not provided; therefore, a review of the manufacturing records could not be completed. No actions will be taken at this time. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. Invasive procedures involve some patient risks. Although serious complications are relatively uncommon, it is common practice to consider the potential benefits in relation to the possible complications of use of this product. No description of the patient¿s anatomy was provided; therefore, it cannot be determined if tissue fragility was present. The product ifu contains the following caution: care should be taken to ensure a firm grasp of the vessel when two compliant inserts are used, since traction is reduced and the possibility of slippage is increased. It is unknown if user or procedural factors may have contributed to this event.
 
Event Description
As reported, during use in an aortic valve replacement and bypass surgery, the clamp jaws did not confront each other correctly, causing an aortic dissection, which was repaired. There was no allegation of patient injury. Unfortunately, the device is not available for evaluation as it was discarded by the customer. Inquired of patient demographics, unable to be obtained.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
Type of DeviceSOFT86 INSERTS
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina , san cristobal
DR
Manufacturer (Section G)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina , san cristobal
DR
Manufacturer Contact
brian hurd-servin
one edwards way
irvine, CA 92614
9492506423
MDR Report Key6344481
MDR Text Key67802580
Report Number2015691-2017-00427
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSOFT86
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/20/2017 Patient Sequence Number: 1
-
-