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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

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VASCUTEK LTD; THORAFLEX HYBRID Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2023
Event Type  Injury  
Event Description
Blood leakage: blood leakage occurred from the factory anastomosis between the vascular graft section and the stented graft section.Hemostatic agent was applied to achieve hemostasis and the procedure was successfully completed.No health damage to the patient.Operation type: total arch replacement.Blood loss: unknown.No image available.No additional information available.This report is being submitted as final for mfg report #9612515-2023-00031 to provide event closure information for comp (b)(4).
 
Manufacturer Narrative
Manufacture's narrative.Clinical code.4582-no clinical signs, symptoms or conditions: no health damage to the patient.Impact code.2199-no health consequences or impact: no health damage to the patient.Medical device problem.3190-insufficient information: the site confirmed on 01 nov 23 that no further information would be obtained.Component code.4755-part/component/sub-assembly term not applicable.Type of investigation.4119- insufficient information: the site confirmed on 01 nov 23 that no further information would be obtained.4114-device not returned: device remains implanted.4110- trend analysis: a 5-year review of similar complaints (leakage > blood oozing) gave an occurrence rate of (b)(4) (complaints v sales).Investigation findings.3221- no findings available: due to insufficient information being provided from the site further investigation could not be carried out.Investigation conclusion.4315- cause not established: due to insufficient information being provided from the site further investigation could not be carried out.
 
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Type of Device
THORAFLEX HYBRID
Manufacturer (Section D)
VASCUTEK LTD
newmains avenue
inchinnan
glasgow, PA49R R
UK  PA49RR
Manufacturer (Section G)
VASCUTEK LTD
newmains avenue
inchinnan
glasgow, PA49R R
UK   PA49RR
Manufacturer Contact
jason whittle
newmains avenue
inchinnan
glasgow, PA49R-R
UK   PA49RR
MDR Report Key18169588
MDR Text Key328533126
Report Number9612515-2023-00031
Device Sequence Number1
Product Code QSK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P210006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Repair
Type of Report Initial
Report Date 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Catalogue NumberTHP3034X100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2023
Initial Date FDA Received11/20/2023
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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