MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD CAROTID PATCH KNITTED ULTRATHIN; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HGKTP08/75CPUT(1)

Device Problem Inaccurate Information (4051)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.It was reported that the product is available for investigation, it should be returned to intervascular for examination.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

(b)(4).The customer ordered a patch hgktp08/75cput (1).The patch is the utrathin, the box is from a knitted and the sticker is from an ultrathin.

Event Description

See initial mfr report#1640201-2020-00009.Complaint # (b)(4).

Manufacturer Narrative

(10/3221) no investigation could be performed on the actual device.Indeed, the device involved in the event is available but not received by manufacturer at this date.The delay in returning the product is due to the current sanitary crisis.However, since the problem was a mismatch between box and product, we were able to investigate the issue with the use of pictures provided by the hospital.See codes 4112/4245 below.(4112/4245) the qa manager carried out an investigation based on pictures provided by the hospital and our traceability data.The main conclusions are: the most probable origin of the event is an error occurring during a defective box replacement taking place either during the preparation of the packaging components or either during the final packaging process itself.No other product has been impacted.(25) the conducted investigation concluded that the origin of the event is a punctual error occurring during the manufacturing process and confirmed that the product does not conform to the specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.

• Brand Name: HEMAGARD CAROTID PATCH KNITTED ULTRATHIN
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9937990
• MDR Text Key: 195922419
• Report Number: 1640201-2020-00009
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401015208
• UDI-Public: 00384401015208
• Combination Product (y/n): N
• PMA/PMN Number: K983819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HGKTP08/75CPUT(1)
• Device Catalogue Number: HGKTP08/75CPUT (1)
• Device Lot Number: 20B20
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1