MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; VASCULAR POLYESTER GRAFT

Model Number	IGW0018-15
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to the manufacturer for evaluation.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Delivery of damaged packaging.
Additional Manufacturer Narrative
(10/193) the involved product was returned to intervascular and was inspected by our quality assurance (qa) supervisor for an evaluation of the damage extent.His observations are as follows: the product box has arrived damaged and sealed with tape.There is a match between the labelling of the box and the external tyvek.The product contained in the shell corresponds to the labelling.There are no instructions-for-use or patient labels.In conclusion, the product does not comply with the specifications due to a damaged outer packaging and missing labelling documents.Based on the traceability of the device, it appears that it was delivered in 2014 to a consignment stock in frankfurt, kept in storage for 4 years and then delivered to the hospital in homburg in 2018.It is assumed that the cause of the event is related to inappropriate storage conditions.(4308) the most likely cause of this event is an inappropriate storage of the device at the consignment stock.Because of that, the situation was reported to the sales and service unit (ssu) in order to investigate its cause and take the appropriate corrective actions.

• Brand Name: INTERGARD WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8099920
• Report Number: 1640201-2018-00025
• Device Sequence Number: 13931994
• Product Code: DSY
• UDI-Device Identifier: 00384401000136
• UDI-Public: 00384401000136
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: IGW0018-15
• Device Catalogue Number: IGW0018-15
• Device Lot Number: 14E29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1