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	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other similar complaint concerning an inner lid not completely sealed was reported on the same sterilization lot.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.The involved product was returned to intervascular and was visually inspected by our quality assurance supervisor.His observations are as follows: "the product arrived in its box but damaged and torn.The outer lid is open, the inner lid is partially open.There is a match between the product, the labelling of the box and the patient set.After manual peeling of the inner lid of the blister, it appears that the sealing area is 100% visible without defect found according to the internal list of acceptance/rejection criteria for primary packaging (b)(4).This whitish area confirms that the transfer between the coating of the lids and the blisters was 100% done on the sealing area because, if this was not the case, we would have transparent areas on the sealing area." the cause of the event remains unknown.However, the conducted investigation and inspection performed suggest that the product was not defective.
Event or Problem Description
When the doctor opened outer packing, they found the inner packing is not completely sealed.And then they change another one for 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
• MDR Report Key: 9316484
• Report Number: 1640201-2019-00083
• Device Sequence Number: 14107351
• Product Code: DSY
• UDI-Device Identifier: 00384401000235
• UDI-Public: 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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: 07/31/2022
• Device Model Number: IGW0028-15
• Device Catalogue Number: IGW0028-15
• Device Lot Number: 17H31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1