MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	IGW0030-30
Medical Device Problem Codes	Flaked (1246); Product Quality Problem (1506); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that when an intergard woven straight graft 30cm x 30cm was prepared for use, the customer noticed that it was not suitable for use due to the color change observed on the graft.In addition, it was reported that a hair was observed on the graft.¿ moreover, it was reported that particles in the graft were spilled.The customer wanted to prevent the spillage by cutting a portion of it.However, the particles continued to fall out from the cut parts.
Additional Manufacturer Narrative
(10/3233) it was reported that the product is available.Currently, the shipping process is ongoing.A visual product inspection is scheduled.(4109/3233) the review of historical data indicated that one other similar complaint (b)(6) was reported by the same customer for the same sterilization lot number 21h19 and at the same date.Refer to initial mdr mfg report #(b)(4).The investigation is still ongoing.(3331/213) the device history records review concluded that there was no non conformance/planned deviation in relation with the event (11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.Evaluation anticipated but not yet begun.
Additional Manufacturer Narrative
(10/4248) the involved device was returned to intervascular.A visual inspection was performed by two quality control (qc) technicians.They observed that the returned product has been manipulated and cut.The observation results were analyzed by the quality assurance supervisor, who concluded that given the condition of the returned graft, it is not possible to investigate further.(4109/213) the review of historical data indicated that another similar complaint (b)(4) about stain on the graft for lot number 21h19 was reported by the same customer and at the same date.The investigation findings of complaint #(b)(4).Concluded that the involved device was in compliance with the product specifications.(4315/19) based on the investigation findings, no conclusion can be drawn on the exact origin of reported incident.Following the inspection results of returned device, it was observed that the customer had handled and cut the product.Considering its condition, it is not possible to determine the cause of the customer's observation and no further investigation can be carried out.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT
• 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: 16975686
• Report Number: 1640201-2023-00013
• Device Sequence Number: 2290526
• Product Code: DSY
• UDI-Device Identifier: 00384401000266
• UDI-Public: (01)00384401000266
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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 Expiration Date: 07/31/2026
• Device Model Number: IGW0030-30
• Device Catalogue Number: IGW0030-30
• Device Lot Number: 21H19
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown