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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE CLAMP, VASCULAR

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EDWARDS LIFESCIENCES INTRACLUDE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to edwards for evaluation. Evaluation is in progress. It was reported that during prepping an icf100 device, a deformity of the cardioplegia lumen was noted. It is unclear if the lumen or the balloon was obstructing the opening. A definitive root cause could not be determined at this time. A supplemental mdr will be submitted once device evaluation is complete. Edwards lifesciences will continue to monitor all reported events.
 
Event Description
It was reported that when prepping an icf100 device, a deformity of the cardioplegia lumen was noted at the tip of the catheter. It is unclear if the lumen or the balloon was obstructing the opening. Since the edwards rep did not want to place the icf100 in the patient and then have a problem, the nurse opted to replace with a new product. The device was returned for evaluation.
 
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Brand NameINTRACLUDE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
irvine, CA 92614
9492504062
MDR Report Key10664479
MDR Text Key240636698
Report Number3008500478-2020-00209
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2022
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number63288284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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