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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC INTRAAORTIC OCCLUSION DEVICE CLAMP, VASCULAR

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EDWARDS LIFESCIENCES LLC INTRAAORTIC OCCLUSION DEVICE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned to edwards for evaluation as it was discarded. Attempts to retrieve additional information is in process. If additional information is received a supplemental mdr will be submitted. The cause of the event was most likely due to procedural related factors. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
 
Event Description
Edwards received information of a iatrogenic balloon rupture. The device was placed without problem, but while placing the left trigone sutures, surgeon placed too deeply and punctured the balloon. Surgeon was immediately aware of the incident and did not feel that this was a product failure. The punctured balloon was removed and a new balloon was placed without incident. Post-operative the patient did well. The surgeon is adamant that the balloon puncture was iatrogenic and device functioned properly. Product lot number is not available as the box was already removed for trash. No pictures are available nor patient information.
 
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Brand NameINTRAAORTIC OCCLUSION DEVICE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
ms mle-2
irvine, CA 92614
9492504062
MDR Report Key11610760
MDR Text Key251784995
Report Number2015691-2021-02245
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberICF100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/02/2021 Patient Sequence Number: 1
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