MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175126P0
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: the event date was set on (b)(6) 2020 as it was the day the damage was found.However the parcel was in transit from (b)(6) to (b)(6) 2020, therefore the event may have occurred between these two dates.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Compaint #(b)(4) - this mdr is part of a series of 5 mdrs involving the 5 products in the parcel.The customer refused the parcel as it was damaged: crushed and wet.
Additional Manufacturer Narrative
(10/3236) the damaged parcel containing the five involved products was returned to intervascular and the content was inspected by the quality assurance manager for an evaluation of the damage extent.He observed that among the five products, two products showed a product package damaged and the three other were not damaged.The origin of the damage was evaluated as probably due to a shock during transportation because one of the product box was ripped off.The product involved in this mdr was one of the 2 damaged products.(4308) the most likely cause of this event is an inappropriate handling of the parcel during transport.An internal non-conformity report has been initiated in order to take appropriate actions if necessary.Please note the presence of the following mention on the instructions for use, "if the graft is inadvertently rendered non-sterile, or the package is opened or damaged, discard the graft".
Event or Problem Description
See initial mfr report # 1640201-2020-00017.Complaint # (b)(4).

• Brand Name: HEMASHIELD PLATINUM WOVEN
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 10289442
• Report Number: 1640201-2020-00017
• Device Sequence Number: 1020291
• Product Code: MAL
• UDI-Device Identifier: 00384401018063
• UDI-Public: 00384401018063
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 02/28/2025
• Device Model Number: M00202175126P0
• Device Catalogue Number: M00202175126P0
• Device Lot Number: 20C25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1