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

Model Number IGW0018-15

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2018

Event Type  malfunction  

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 Description

Delivery of damaged packaging.

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
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8099920
• MDR Text Key: 128209069
• Report Number: 1640201-2018-00025
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000136
• UDI-Public: 00384401000136
• Combination Product (y/n): N
• PMA/PMN Number: K970843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1