MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR; VASCULAR POLYESTER GRAFT

Model Number	M002020851270
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to intervascular for content examination.The graft corresponding to the product box labeling was manufactured on august 2015 by intervascular (b)(4) in (b)(6), it was delivered to the consignment stock at (b)(6) hospital on (b)(6) 2016.The graft that was found inside the product box was manufactured by maquet cardiovascular llc in the united states and was delivered to the consignment stock at (b)(6) hospital on (b)(6) 2014.Therefore, it is assumed that the packaging transfer occurred during storage at the consignment stock.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
Staff opened the box and noticed that the graft inside did not match the box labeling.They thought they were opening a graft whose dimensions were 12mmx7mmx40cm, instead they found a graft whose dimensions were 14mmx7mmx40cm.A replacement device was used to complete the procedure.No patient was involved.It was reported that the event occurred some time ago but there was a reporting omission.The event date is unknown.
Additional Manufacturer Narrative
(10/3221) despite repetitive efforts, the involved product was never returned to intervascular for an evaluation of the packaging components.Device not available for evaluation has been modified accordingly (4308) the most likely cause of this event is a packaging mix-up during storage at the consignment stock.

• Brand Name: HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8260461
• Report Number: 1640201-2019-00005
• Device Sequence Number: 1306571
• Product Code: MAL
• UDI-Device Identifier: 00384401017691
• UDI-Public: 00384401017691
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: 07/31/2020
• Device Model Number: M002020851270
• Device Catalogue Number: M002020851270
• Device Lot Number: 15H26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1