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

Model Number HGK12/75CPUT (1)

Device Problems Component Missing (2306); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported to intervascular that when the sister opened a sealed box, it was empty inside.Hgk12-75cput, lot: 21l25, s/n: (b)(4).Complaint #(b)(4).

Manufacturer Narrative

(4109/213) as the occurrence of this type of event is low, it was decided to perform an additional review of historical data over the last five years (from january 2017 to may 2022) which indicated that another similar complaint was reported.Regarding this complaint, the conducted investigation indicated that the device was not defective at the time of manufacturing.It was noted that it was highly unlikely that an omission had occurred during the packaging stage because each component is scanned individually.(4110/213) occurrence rate was calculated for similar events on the same manufacturing line (intergard/hemagard) for a 5 years period from 1- jan-2017 to 31-may-2022.The occurrence rate was inferior to (b)(4)%, which is below the anticipated occurrence rate (maximum) of (b)(4)%.(10/4248) a visual inspection of the returned product was performed by the quality assurance (qa) supervisors: "the box is very damaged.Only the leaflet accompanies the box.None of the following elements were present: outer shell, inner shell, product and patient set.Note that the 2 tamper-evident labels are positioned on the sides of the box.".They concluded that, considering its condition, it seems very likely that the product was lost when the box was opened.(19) no conclusion can be drawn on the exact origin of the defect since the product was manipulated by the user.However, based on the qa supervisors assessment, it seems very likely that the the cause of the event is related to the user.

Event Description

See mfg reports #1640201-2022-00013.Complaint #(b)(4).

• Brand Name: HEMAGARD CAROTID KNITTED UT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 14073482
• MDR Text Key: 298598783
• Report Number: 1640201-2022-00013
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014935
• UDI-Public: (01)00384401014935
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K983819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HGK12/75CPUT (1)
• Device Catalogue Number: HGK12/75CPUT (1)
• Device Lot Number: 21L25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose