MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Catalog Number THP2426X100J

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative: clinical code: 4582-no clinical signs, symptoms or conditions: as reported in intake form no health damage to the patient.Impact code: 2199-no health consequences or impact: as reported in intake form no health damage to the patient.Medical device problem: 3190-insufficient information: site confirmed on 31 oct 23 that no further information is available for this event, device will not be returned for analysis as remains implanted.Component code: 4755-part/component/sub-assembly term not applicable: type of investigation: 4114-device not returned: device remains implanted.3331-analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4110-trend analysis: a 5-year review of similar complaints (leakage>> blood oozing) gave an occurrence rate of 0.049% (complaints v sales).4119-insufficient information available: site confirmed on 31 oct 23 that no further information is available for this event, device will not be returned for analysis as remains implanted.

Event Description

Blood leakage: after anastomosis of the collar, a small amount of blood leakage was observed from the junction when the blood flow was returned.Hydrofit and bioglue were therefore injected to achieve hemostasis.No health damage to the patient.Operation type: tar; blood loss: unknown; no image available; no additional information available; tc no: (b)(4).

Event Description

Blood leakage: after anastomosis of the collar, a small amount of blood leakage was observed from the junction when the blood flow was returned.Hydrofit and bioglue were therefore injected to achieve hemostasis.No health damage to the patient.Operation type: tar; blood loss: unknown; no image available.No additional information available tc no: (b)(6).This report is being submitted as a final for mfg.Report #9612515-2023-00032, to provide event closure information for (b)(4).

Manufacturer Narrative

Manufacturers narrative.Clinical code: 4582-no clinical signs, symptoms or conditions: as reported in intake form no health damage to the patient.Impact code: 2199-no health consequences or impact: as reported in intake form no health damage to the patient.Medical device problem: 3190-insufficient information: site confirmed on 31 oct 23 that no further information is available for this event, device will not be returned for analysis as remains implanted component code: 4755-part/component/sub-assembly term not applicable.Type of investigation: 4114-device not returned: device remains implanted 3331-analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device 4110-trend analysis: a 5-year review of similar complaints (leakage>> blood oozing) gave an occurrence rate of (b)(4) (complaints v sales).4119-insufficient information available: site confirmed on 31 oct 23 that no further information is available for this event, device will not be returned for analysis as remains implanted investigation findings: 3221 - no findings available - device not returned and customer confirmed no further information is available for this event.Investigation conclusions: 4315 - cause not established - a cause could not be established as the product was not returned, the manufacturing records confirm the device was manufactured according to specification, and there is no further information available for this event.

• 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 Key: 18189317
• MDR Text Key: 328737811
• Report Number: 9612515-2023-00032
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP2426X100J
• Device Lot Number: 25324181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2023
• 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): Required Intervention