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

Model Number M00202175126P0

Device Problem Product Quality Problem (1506)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported to intervascular that when the doctor opened the product, he found there were some yellow spots on the surface of the graft.He change another graft instead.The event occured prior to use, the surgery was not delayed and no hazard issue occurred.Complaint # (b)(4).

Manufacturer Narrative

(10/3233) the involved device is available and will be returned to intervascular for examination.A visual inspection will be performed.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22b02.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(4102/3233) a retention sample from another sterilization lot number 22b09 was selected based on the same coating parameter as the involved device.A visual inspection will be performed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(10/213) the involved device was returned to intervascular and inspected by the qa supervisor and a qualified quality control technician on 14-dec-2022.Their observations are as follows: "compared to the reported variation, the product shows the usual yellow halos of collagen after sterilization.A more shiny spot is present in one area and corresponds to an excess of collagen that does not go beyond the crimps and is well attached to the greige and therefore does not correspond to a cluster." in conclusion, the device is conform to the product specifications.(67) the conducted investigation concludes that the product is conform to the specification.

Event Description

Complaint #(b)(4).Mfg report #1640201-2022-00032.

Manufacturer Narrative

(4102/213) a retention sample from another sterilization lot number 22b09 was selected based on the same coating parameter as the involved device.A visual inspection was performed on (b)(6) 2022 by the quality assurance superviseur, which concluded that : the prosthesis is uniformly yellow, no collagen excess.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint # (b)(4).

• 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: 15575941
• MDR Text Key: 302095982
• Report Number: 1640201-2022-00032
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 00384401018063
• UDI-Public: (01)00384401018063
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00202175126P0
• Device Catalogue Number: M00202175126P0
• Device Lot Number: 22B02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1