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

Model Number HGK25/150P (1)

Device Problem Defective Device (2588)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

The product is available for investigation and was returned to the manufacturer on (b)(6) 2022.On (b)(6) 2022, the qa manager concluded the following after performing the visual inspection of the returned product: "the product arrived out of its pouch and stained.The box, pouch and patient set labels match.The product does not have the dimensions indicated by the labeling (25mm x 150mm).Measurements taken indicate: 75mm length; minimum width 14mm; maximum width 17mm.It does not comply with product specifications (dimension & visual characteristics)." on (b)(6) 2022, the qa manager requested further information from the reporter to conclude on the investigation.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

It seems that the patch was way shorter than 150mm.Complaint # (b)(4).

Manufacturer Narrative

More information was requested to the initial reporter in order to clarify the event, however, no information will be obtained as the initial reporter did not want to respond.(4112/10/3221) on 23-march-2022, the qa manager visually inspected the returned patch a second time, following the discovery of the 2nd piece of the patch.The result is as follow: it is very difficult to have an explanation, the patch having been cut.The investigations carried out dhr analysis and review of manufacturing records (mfg operations traceability) do not show any anomaly related to the complaint.In addition, the customer did not want to communicate more elements, it is not possible to go to the end of the investigation." (67) no conclusion can be drawn on the exact origin of the defect since the product was manipulated and cut by the customer moreover the customer did not want to communicate more elements about the event.The cause of the event remains unknown, however, the conducted investigation suggests that the device was not defective at the time of manufacturing.

Event Description

Complaint (b)(4).

• Brand Name: HEMAGARD KNITTED
• 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: 13385461
• MDR Text Key: 295697829
• Report Number: 1640201-2022-00003
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401015116
• UDI-Public: (01)00384401015116
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

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
• Device Operator: Health Professional
• Device Model Number: HGK25/150P (1)
• Device Catalogue Number: HGK25/150P (1)
• Device Lot Number: 20B27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1