MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED BIFURCATED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HGK1608
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that in an emergency setting, the vascular surgeon was preparing a hemagard knitted bifurcation graft by cutting it to size when she noticed fraying of the fabric.She decided to not use the graft and switch to a gelsoft plus bifurcation graft by terumo aortic.Complaint#: (b)(4).
Additional Manufacturer Narrative
(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number: 22d21.(3331/3233) the device history records review is pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
(b)(4).
Additional Manufacturer Narrative
(4111) additional information was received from the distributor.It was indicated that the graft is available for analysis and metzenbaum dissecting scissors were used to cut the graft.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(10/3233) it was reported that the product is available, it should be returned to intervascular for analysis.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Complaint#: (b)(4).
Additional Manufacturer Narrative
(10/213) the involved device was returned to intervascular and inspected by the quality assurance manager.As part of the visual inspection, the involved product was tested by cutting it.No fraying was observed.Based on the testing performed on the returned product, it was concluded that the frayed appearance is probably due to the instrument used to cut the graft or to the cutting technique.(61) the investigation concluded that the cause of the event is probably due to the instrument used to cut the graft or to the cutting technique.Please note that as per current product instructions for use, in the section "directions for use" it is indicated to use sharp surgical scissors to trim the intergard/ hemagard knitted vascular grafts.

• Brand Name: HEMAGARD KNITTED BIFURCATED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 16583556
• Report Number: 1640201-2023-00008
• Device Sequence Number: 11171486
• Product Code: DSY
• UDI-Device Identifier: 00384401014027
• UDI-Public: (01)00384401014027
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: HGK1608
• Device Catalogue Number: HGK1608
• Device Lot Number: 22D21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 05/10/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/13/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown