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

Model Number	IGW0028-15
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number 23f29.Moreover, there is no other similar complaint for hole in the tyvek lid between 1-jan-2023 to 12-mar-2024.(10/213/4248) the involved device was visually inspected by the quality assurance supervisor.The visual inspection confirmed the presence of a hole on the inner tyvek lid of the involved product.It was concluded that the product is non compliant with the product specification, the sterile barrier has been broken.It should be noted that at the primary packaging stage, no thin and sharp object is present on the production line.The historical data review results were provided to the qa supervisor to determine the cause of the event.It was concluded that the most likely root cause of the incision was accidental handling of the product packaging when unpacking the prosthesis.(4315) based on the evaluation of the returned product and the investigation findings, no conclusion can be drawn of the exact origin of the defect.One hypothesis is that the incision leading to the hole may have been caused during packaging handling after the outer lid was removed at the time of unpackaging the prosthesis.
Event or Problem Description
It was reported to intervascular that after opening the product packaging, a pinhole was observed on the surface of the internal tyvek lid.The product was was not used and was replaced to complete the operation.

• 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: 18902875
• Report Number: 1640201-2024-00002
• Device Sequence Number: 7876144
• Product Code: DSY
• UDI-Device Identifier: 00384401000235
• UDI-Public: (01)00384401000235
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984294
• 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
• Report Date (Section B): 03/14/2024

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: IGW0028-15
• Device Catalogue Number: IGW0028-15
• Device Lot Number: 23F29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2024
• Initial Report FDA Received Date: 03/14/2024
• 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
• Patient Sex: Unknown