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

Model Number	HEK08/75CP (1)
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	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) it was indicated that the actual device involved was available for testing.It will be returned for analysis.(4109/213) the review of historical data indicated that no similar complaint was reported for the same sterilization lot number 23f29.(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 a hemacarotid patch was being opened for the scrub nurse and the circulating nurse noticed that the packaging looked wet/greasy.Product was not given to the scrub nurse and the charge nurse was notified.No effect - did not reach patient - detected before use.Complaint #(b)(4).
Additional Manufacturer Narrative
Corrected data: block h6, medical device problem "2975" was updated to "1506".Addtl mfg narrative: (10/213) the involved device was returned and inspected by the quality assurance department.The inspection allowed to conclude that that the product is conform to the product specifications.It should be noted that the internal tyvek lid had a translucent stain.This stain corresponds to a glycerol stain, which does not affect the quality nor the sterility of the product.(67) the investigation based on the product analysis concluded that the product conforms to product specifications.
Event or Problem Description
Complaint # (b)(4).

• Brand Name: HEMACAROTID KNITTED
• 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: 19537477
• Report Number: 1640201-2024-00008
• Device Sequence Number: 17748608
• Product Code: DSY
• UDI-Device Identifier: 00384401001416
• UDI-Public: (01)00384401001416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: HEK08/75CP (1)
• Device Catalogue Number: HEK08/75CP (1)
• Device Lot Number: 23F29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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