MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID

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).

• 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 Key: 17903400
• MDR Text Key: 325248820
• Report Number: 9612515-2023-00022
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P2100006
• Number of Events Reported: 1
• 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 Number: THORAFLEX HYBRID
• Device Catalogue Number: THP3032X100J
• Device Lot Number: 25346974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other