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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALY CARBOMEDICS CARBO-SEAL CONDUIT
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SORIN GROUP ITALY CARBOMEDICS CARBO-SEAL CONDUIT Back to Search Results
Model Number AP
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Information (3190)
Event Date 04/02/2014
Event Type  malfunction  
Event Description
The manufacturer was notified on (b)(4) 2014 that after the implantation of e carbomedics carbo-seal conduit the surgeon observed a severe leak due to a dehiscence between the conduit and the valve that required the use of pledgets to fix the conduit to the valvular ring.It was reported that the patient had a normal recovery.
 
Manufacturer Narrative
The device is still implanted.
 
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Brand Name
CARBOMEDICS CARBO-SEAL CONDUIT
Type of Device
CARBOMEDICS CARBO-SEAL CONDUIT
Manufacturer (Section D)
SORIN GROUP ITALY
IT 
Manufacturer Contact
giovanni brgamasco
via per crescentino snc
saluggia (vercelli) 14087
IT   14087
MDR Report Key4284145
MDR Text Key5299690
Report Number3005687633-2014-00003
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P900060
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAP
Device Catalogue NumberAP-27
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2014
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? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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