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

Model Number	M00202175632P0
Medical Device Problem Codes	Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
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 similar complaint was reported for the same sterilization lot number 23g05.(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
It was reported that prior to use the customer observed little dots inside the packaging and the product was not used.Complaint # (b)(4).
Additional Manufacturer Narrative
Corrected data: on block h6, the medical device problem code "2975" was updated to "1506".Addtl mfg narrative: (10/213) the involved device was returned to intervascular for examination.A visual inspection was performed by the quality assurance engineer, manufacturing supervisor and manufacturing lead operator.It was concluded that the involved product is conform to the product specifications.Indeed, the little dots observed by the customer are translucent particles identified as collagen filament which are inherent part of the product.(67) based on the visual inspection the product is conform to the product specifications.Indeed, the little dots observed by the customer are translucent particles identified as collagen filament which are inherent part of the product and, per acceptance criteria, small collagen particles are routinely accepted.
Event or Problem Description
Complaint#: (b)(4).

• Brand Name: HEMASHIELD PLATINUM WOVEN 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: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 21738588
• Report Number: 1640201-2025-0000006
• Device Sequence Number: 14454919
• Product Code: MAL
• UDI-Device Identifier: 00384401018391
• UDI-Public: (01)00384401018391
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K021213
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: M00202175632P0
• Device Catalogue Number: M00202175632P0
• Device Lot Number: 23G05
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown