MAUDE Adverse Event Report: INTERVASCULAR SAS HEMACAROTID PATCH KNITTED ULTRATHIN; VASCULAR POLYESTER GRAFT

Model Number	HEK10/75CPUT (1)
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint device history records, indicated that the patch was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.A visual inspection of the returned product was performed by our quality assurance (qa) manager.The product box was opened (broken seal) and contained only the patient labels set and the instructions-for-use: the device and primary packaging were missing.The product, as it was received, was not meeting its specification.However, the cause of the event remains unknown.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.No conclusion could be drawn.The conducted investigation would tend to indicate that the device was not defective at the time of manufacturing.It is highly unlikely that an omission has occurred during the packaging stage because each component is scanned individually.However, a non-conformity report has been initiated in order to further investigate the event and take appropriate corrective actions if necessary.
Event or Problem Description
When the box was opened, the patch was missing, the only thing inside was the ifu and the labels.The box was not opened before, the customer is 100% sure and is using the product on a regular basis.No harm to patient involved and the surgeon was not aware of the incident, they had 4 more boxes on the shelf.

• Brand Name: HEMACAROTID PATCH KNITTED ULTRATHIN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8099914
• Report Number: 1640201-2018-00024
• Device Sequence Number: 11289229
• Product Code: DSY
• UDI-Device Identifier: 00384401001485
• UDI-Public: 00384401001485
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/23/2018

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: 04/30/2023
• Device Model Number: HEK10/75CPUT (1)
• Device Catalogue Number: HEK10/75CPUT (1)
• Device Lot Number: 18E31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1