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

Model Number	HEK08/75CPUT (1)
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because the awareness date for this incident is 01/30/2020, we should have submitted this report at least on 02/29/2020.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Complaint (b)(4).Event description: the surgeon asked for a carotid patch of 8m, the nurse suggested the hek08/75cput.When he took the patch in hand he realized that it was not the right size (wider (about 11 or 12 mm)).He cut out a piece of the patch and set it aside for testing.Note that the sample is clean.He used the rest of the patch for the patient.Note that the surgeon had to re-cut the patch whereas he usually uses 8 mm patches because he does not want to retouch and cut the patch.
Additional Manufacturer Narrative
(3331/170) in view of supporting the identification of possible causes, an additional investigation has been performed consisting of: the observation of the concerned work station.The review of manufacturing records by date.Following this additional investigation, the most probable root cause was identified as follows: error in using the wrong cutting tool, without checking the width measurement afterwards.As a result, a patch of 8 mm width was mistakenly declared in the computer system, resulting in the creation of a finished product label associated to the product but not corresponding to the product.(143) the conducted investigation concluded that the product was defective.There was a quality control deficiency (lack of verification of the width) due to an isolated human error.A reminder to the involved employee was required, in the non-conformity report associated to the complaint, as a corrective action.
Event or Problem Description
See mfr report # 1640201-2020-00006.Complaint #: (b)(4).
Additional Manufacturer Narrative
(3331/213) the device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.(10/170) the involved product was returned to intervascular and was inspected by our quality supervisor.Conclusion is as follows: "after having measured the defective patch, we can actually confirm that it is not an 08mm patch, we mesure more a 10mm patch.".(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
See initial mfr report # 1640201-2020-00006.Complaint #(b)(4).

• Brand Name: HEMACAROTID KNITTED ULTRATHIN PATCH
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9775441
• Report Number: 1640201-2020-00006
• Device Sequence Number: 2216652
• Product Code: DSY
• UDI-Device Identifier: 00384401001478
• UDI-Public: 00384401001478
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: HEK08/75CPUT (1)
• Device Catalogue Number: HEK08/75CPUT (1)
• Device Lot Number: 19K24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/06/2020; 04/23/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/01/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1