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

Model Number	M00202175928P0-PLATINUM WOVEN AORTIC ARCH 4B
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation, the value was left blank because the name of the initial reporter and his occupation are unknown.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number (20m16) (3331/4245) a review of manufacturing records (mfg operations traceability) allowed us to make the assumption that a possible inversion occurred at the primary packaging step between product ref (b)(4) (lot 20m16, sn(b)(4)) and product ref (b)(4) (lot 20m16, sn(b)(4)), leading to a mislabeling of both products.As requested in the product non-conformity report opened for this issue, a health hazard evaluation (hhe) has been initiated concerning the second product involved by the issue.(10/4245) the complaint returned product was inspected.The conclusion confirmed that the product blister inside the box does not match the identification of the box, the identification of the patient label set and the identification of the graft sizers.(25) the conducted investigation concluded that the product involved in the complaint was not conform due to a product mislabeling occurring because instructions were not strictly followed at primary packaging and final packaging check steps.A capa has been initiated in order to take appropriate actions.
Event or Problem Description
Customer complaint #(b)(4) was mentioning a mislabeling as described below: when the box was opened before use for the patient, it was confirmed that a different product was packaged.Label on the box is ref (b)(4) (lot 20m16, sn(b)(4)), but the actual product inside was ref (b)(4) (lot 20m16, sn1(b)(4)).The product was returned back to the distributor from end user site.We have received confirmation that no patient was harmed by the incident.
Event or Problem Description
See mfg report(s) # 1640201-2021-00026.Complaint #(b)(4).
Additional Manufacturer Narrative
A recall was initiated on (b)(6) 2022 to withdraw two inverted products from the market.One mislabeled product is located in the us (corresponding to complaint #(b)(4).Mfg report number 1640201-2021-00034).One mislabeled product is located in china (corresponding to this complaint #(b)(4) - mfg report number 1640201-2021-00026).

• Brand Name: HEMASHIELD PLATINUM WOVEN
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: philip gaillard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 12232633
• Report Number: 1640201-2021-00026
• Device Sequence Number: 5403557
• Product Code: MAL
• UDI-Device Identifier: 00384401018650
• UDI-Public: (01)00384401018650
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 11/30/2025
• Device Model Number: M00202175928P0-PLATINUM WOVEN AORTIC ARCH 4B
• Device Catalogue Number: M00202175928P0
• Device Lot Number: 20M16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown