MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD GOLD KNITTED STRAIGHT; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M002020952080
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that when the staff opened the involved device, reference: m002020952080, dimension 8mmx60cm, they noticed the graft was not as long as it should be.It is about 30cm instead of 60cm.The sealed pouch has not been opened.
Additional Manufacturer Narrative
(10/3233) it was reported that the involved device is available, it should be returned to intervascular for examination.(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number 24e01.(4121/3233) 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.
Additional Manufacturer Narrative
(10/3233) the involved product was returned to intervascular for examination.Product analysis by the quality assurance department is pending.(4121/213) the device history records review concluded that there was no non-conformance in relation with the event reported.(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 product was returned to intervascular for examination.A visual inspection was performed was performed by a quality control technician, the production supervisor and the quality assurance engineer.It was concluded that the involved device is conform to the product dimensional specifications.The length measured of the product under tension is 61 cm (67) based on the investigation findings, in particular the product visual inspection, it was concluded that the product is conform to the product dimensional specifications.It should be noted that, as per the instructions-for-use of hemashield gold knitted graft, the total graft length printed on the product label is the minimum usable length.According to our procedures and in accordance with the applicable international standard iso 7198, the usable length of vascular grafts is measured when graft is stretched at a medium tension without completely eliminating the embossing rings.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: HEMASHIELD GOLD KNITTED STRAIGHT
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• 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: jessica hinostroza ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 21736765
• Report Number: 1640201-2025-0000005
• Device Sequence Number: 9002385
• Product Code: MAL
• UDI-Device Identifier: 00384401017615
• UDI-Public: (01)00384401017615
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: M002020952080
• Device Catalogue Number: M002020952080
• Device Lot Number: 24E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 05/09/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/29/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown