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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
Catalog Number THP3034X100B
Device Problem Insufficient Information (3190)
Patient Problem Embolism/Embolus (4438)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
Clinical code: 4438 embolism / embolus: ct revealed an embolus of the left common femoral artery and a right common femoral artery pseudoaneurysm.Impact code: 4624 surgical intervention: left common femoral artery embolectomy and right common femoral artery pseudoaneurysm was repaired.4641 unexpected medical intervention: patient was started on iv heparin and taken to or by vascular surgery for surgical intervention.Medical device problem code: 3190 insufficient information: a/w batch details to be provided from complainant.Component code 4756 appropriate term/ code not available.Type of investigation: (b)(4).Investigation findings: 213 - no device problem found: site confirmed on 23 aug 2023 that this event ws not device related.Investigation conclusion: 4310 - caused trace to non-device related factors: site confirmed on 23 aug 2023 that this event ws not device related.
 
Event Description
As per reporter's narrative: thor study.Clinical trial thor_torontogeneral patient number (b)(6), a female patient of 77 years old had relevant medical condition of thoracic aneurysm, coronary artery disease, copd, diabetes (type unknown), history of stroke and taking antiplatelets (asa81) prior to procedure.Former smoker and asa grade 4.The events were related to the device failure/ deficiency but not related to procedure or pre-existing condition and surgical intervention was required.On the post-operative day 6/7, patient developed left lower extremity coolness, pain and tingling and loss of left dorsalis pedalis/posterior tibialis pulses.Ct revealed an embolus of the left common femoral artery and a right common femoral artery pseudoaneurysm.Patient was started on iv heparin and taken to or by vascular surgery for surgical intervention.Left common femoral artery embolectomy and right common femoral artery pseudoaneurysm was repaired.Additional information received from site on 23 aug 23 confirmed this event was not device related.Site also confirmed unfortunately they are unable to provide batch details for this event.This report has been submitted as initial/ final for mfg.Report fda 9612515-2023-00013.
 
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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 Key17609856
MDR Text Key321803789
Report Number9612515-2023-00019
Device Sequence Number1
Product Code QSK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P210006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Remedial Action Repair
Type of Report Initial
Report Date 08/24/2023
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 Catalogue NumberTHP3034X100B
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/28/2023
Initial Date FDA Received08/24/2023
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;
Patient Age77 YR
Patient SexFemale
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