MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD CAROTID PATCH KNITTED ULTRATHIN; VASCULAR POLYESTER GRAFT

Model Number	HGKTP06/75CPUT (1)
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional 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 is ongoing, results are pending.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 or Problem Description
The reference line of the involved patch was not straight, implantation of the device was not possible.The same happened with another patch of the same lot (see manufacturer report 1640201-2019-00025 for the other involved device).Another product was used instead.
Additional Manufacturer Narrative
(10/213) the involved product was returned to intervascular and was inspected by our quality assurance (qa) manager.It appears that the product is on the limit of acceptability regarding the straightness of the reference line but nevertheless complies with the specifications.(3331/213) a review of the complaint device history records, indicated that the product was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, this review showed that the quality control (qc) technician rejected part of the same patch strip due to a reference line problem.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
(25) the conducted investigation indicated that the involved product was on the limit of acceptability regarding the straightness of the reference line.Nevertheless, the product is not defective and complies with the current specifications.The cause of the event is related to a miscutting of the patch strip resulting in a shift of the central reference line.Individual patches containing an unacceptable reference line were indeed rejected during manufacturing.As a preventive measure, awareness was raised among all qc technicians of the potential risk of releasing patches with non-straight reference lines.

• Brand Name: HEMAGARD CAROTID PATCH KNITTED ULTRATHIN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8510437
• Report Number: 1640201-2019-00026
• Device Sequence Number: 1962744
• Product Code: DSY
• UDI-Device Identifier: 00384401015192
• UDI-Public: 00384401015192
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2019

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
• Operator of Device: No Information
• Device Expiration Date: 09/30/2023
• Device Model Number: HGKTP06/75CPUT (1)
• Device Catalogue Number: HGKTP06/75CPUT (1)
• Device Lot Number: 18K11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 07/05/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/07/2019; 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1