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

Model Number M00202175132P0

Device Problem Product Quality Problem (1506)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

(10/3233) the involved device was returned to intervascular for examination on october 4th, 2022.A visual inspection by the qa department is pending.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21d07.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(11/3233) a retention sample from the same sterilization lot number 21d07 was selected, based on the same coating parameter as the involved device.A visual inspection is pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

It was reported to intervascular that cardiothoracic consultant / team were in the operating theatre.Upon the graft being opened the consultant / team have noticed yellow patches both on the inner and outer side of the hemasheild platinum woven graft.Consequently the consultant was not happy / comfortable to implant.Chief perfusionist attending the case has contacted getinge to explain the situation.Images have been obtained of the graft and it has been put aside at the hospital should the product require collection and further investigation.There were no adverse events subsequent to the issue with the graft.There was only a minor delay with the surgery whilst another of our grafts (of the same size) was opened and used for implantation.Complaint # (b)(4).

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(10/213) the involved device was returned to intervascular for examination.A visual inspection was performed on 20-oct-2022 by the quality supervisor, a confirmed quality control (qc) technician and a hemashield packaging lead operator, they concluded that : the product has on the left section yellow spots that are similar to collagen excess that are routinely accepted according to the acceptance criteria defined in our specification.This defect is an aesthetic defect.Please note that however the collagen turns yellow over time and is not necessarily visible to the qc and that the excess does not exceed the crimps of the product.(11/213) a retention sample from the same sterilization lot number 21d07 was selected, based on the same coating parameter as the involved device.A visual inspection was performed on 20-oct-2022 by the quality supervisor, it conclude that : the graft is uniformly yellow without collagen excess.(67) the conducted investigation concludes that the product was conform to the specification.

• Brand Name: HEMASHIELD PLATINUM WOVEN STRAIGHT
• Type of Device: 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 15571559
• MDR Text Key: 307083623
• Report Number: 1640201-2022-00030
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 00384401018094
• UDI-Public: (01)00384401018094
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00202175132P0
• Device Catalogue Number: M00202175132P0
• Device Lot Number: 21D07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1