MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM FINESSE ULTRA-THIN KNITTED; VASCULAR POLYESTER GRAFT

Model Number M00202019579P0

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the product is available for investigation, it should be returned to intervascular for examination.A review of the complaint device history records, indicated that the patch was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests including a 100% visual inspection of the patch.Specifically, no anomaly was evidenced in the collagen coating records.A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified.A visual inspection by the qa department will be performed.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

The event occurred during preparation for a procedure.Upon opening the package, the patch was found to have a "sticky brown gunk" down the midline.There was enough of it to contaminate the tech's gloves from touching the patch.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

The involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor and two quality control (qc) technicians.The deficiency reported was confirmed and identified as an excess of collagen.One retention sample from same lot and coated on the same day and under the same conditions as the involved device was visually inspected by our qa supervisor and the two same qc technicians.No anomaly was found.The conducted investigation suggests that the issue was an isolated event probably related to human errors during manufacturing steps.It has been decided to raise awareness of this type of defect among all manufacturing operators concerned, or likely to be concerned.

• Brand Name: HEMASHIELD PLATINUM FINESSE ULTRA-THIN KNITTED
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8383489
• MDR Text Key: 139341529
• Report Number: 1640201-2019-00015
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00384401017950
• UDI-Public: 00384401017950
• Combination Product (y/n): N
• PMA/PMN Number: K962342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2023
• Device Model Number: M00202019579P0
• Device Catalogue Number: M00202019579P0
• Device Lot Number: 18J26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1