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

MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID

  • 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
 

VASCUTEK LTD. THORAFLEX HYBRID Back to Search Results
Model Number THORAFLEX HYBRID
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2023
Event Type  malfunction  
Manufacturer Narrative
Manufacturers narrative section h6 clinical code: 4582 no clinical signs, symptoms or conditions: there was no health damage to the patient.Impact code: 2199 no health consequences or impact: there was no health damage to the patient.Medical device problem: 3190 insufficient information: further information and pre/post op scans have been requested from the site.Component code: 4755 part/component/sub-assembly term not applicable: device has no component parts.Type of investigation: 4109 historical data analysis, 4110 trend analysis: a 5-year review of similar complaints (leakage blood oozing) gave an occurrence rate of (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.3331 analysis of production records: device history records were reviewed which showed no issues with the manufacture of the product and the graft passed porosity testing.4114 device not returned: graft remains implanted.
 
Event Description
Blood leakage: blood leakage was observed from the collar where the cuff was sutured.The leakage was small and hemostasis was successfully achieved using hydrofit.Subsequently, the procedure was completed successfully.No health damage to the patient.Operation type: tar.Blood loss: exact amount is unknown.No image available.No additional information available.
 
Manufacturer Narrative
Clinical code 4582 no clinical signs, symptoms or conditions: there was no health damage to the patient impact code 2199 no health consequences or impact: there was no health damage to the patient medical device problem 3190 insufficient information: further information and pre/post op scans have been requested from the site component code 4755 part/component/sub-assembly term not applicable: -device has no component parts type of investigation 4109 historical data analysis, 4110 trend analysis: a 5-year review of similar complaints (leakage blood oozing) gave an occurrence rate of (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.3331 analysis of production records: device history records were reviewed which showed no issues with the manufacture of the product and the graft passed porosity testing.4114 device not returned: graft remains implanted.Investigation findings 3221 - no findings available - furterh information was requested from the site , however they said they were unable to obtain any further information or imaging for this complaint , 213 - no device problm found - as the device remins implanted and we have no further information on the event and no imaging available no device problem was found.Investigation conclusion.67 - no problem deteted - as the device remained implanted and no further information as avaialble no device problem was detected.
 
Event Description
Tis report is being submitted as follow up #1 for mfg.Report # 9612515-2023-00022 to provide event closure information for comp (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
THORAFLEX HYBRID
Type of Device
THORAFLEX HYBRID
Manufacturer (Section D)
VASCUTEK LTD.
newmains avenue
inchinnan business park
glasgow, renfrewshire PA4 9 RR
UK  PA4 9RR
Manufacturer (Section G)
VASCUTEK LTD.
newmains avenue
inchinnan business park
glasgow, renfrewshire PA4 9 RR
UK   PA4 9RR
Manufacturer Contact
jason whittle
newmains avenue
inchinnan business park
glasgow, renfrewshire PA4 9-RR
UK   PA4 9RR
MDR Report Key17903400
MDR Text Key325248820
Report Number9612515-2023-00022
Device Sequence Number1
Product Code QSK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P2100006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTHORAFLEX HYBRID
Device Catalogue NumberTHP3032X100J
Device Lot Number25346974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2023
Initial Date FDA Received10/10/2023
Supplement Dates Manufacturer Received09/15/2023
Supplement Dates FDA Received10/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2023
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) Other;
-
-