MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM; VASCULAR POLYESTER GRAFT

Model Number	M00202175210P0
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint device history records indicated that the graft was processed and inspected according to established tests and procedures and no anomaly was found.The investigation is still ongoing.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The hospital reported that during preparation for a case, a (b)(4) hemashield platinum woven box was opened.The box was intact and was properly labeled and had the plastic tray inside the box but no graft.
Additional Manufacturer Narrative
The involved device was received by intervascular and was inspected by the quality assurance supervisor.The product was returned with its outer blister unsealed, without moisture pouch, without inner blister and without graft.The product, as it was returned, does not conform to the specification.Considering the condition in which the product was returned (pouch and sealing open), the cause of the reported event can not be identify.No conclusion can be drawn.The investigation performed would tend to indicate that the product was not defective at the time of manufacturing.However, a non-conformance report has been initiated to further investigate the event and take appropriate corrective actions if necessary.

• Brand Name: HEMASHIELD PLATINUM
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7258601
• Report Number: 1640201-2018-00005
• Device Sequence Number: 112382
• Product Code: MAL
• UDI-Device Identifier: 00384401018155
• UDI-Public: 00384401018155
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021213
• 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,Followup
• Report Date (Section B): 03/06/2018

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: 07/31/2022
• Device Model Number: M00202175210P0
• Device Catalogue Number: M00202175210P0
• Device Lot Number: 17H02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1