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

Model Number	M00202175208P0
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, it is unknown if the product is available for return and examination.A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests including a 100% visual inspection.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
During preparation for surgery for an aortic dissection, a hair was found inside the product.The customer finished the operation with another available product from same lot.
Additional Manufacturer Narrative
(10/170) the involved product was returned to intervascular and was inspected by the quality assurance (qa) manager for evaluation.His observations are as follows: "-the box came with a tamper-evident label cut off.-there is a match between the product, the labeling of the box and the patient set.There is no notice ifu or graftsizer.-the product shows: a purple stain at one of its ends ; the presence of 2 fibers outside the graft.-regarding the purple stain, it does not come from our manufacturing process.Regarding the fiber, it could be a dark fiber from the reference line, attached or not to it, and located outside the fabric or a foreign body.The fiber exceeds a surface area of 0.03mm2 according to tappi chart mes 19-037.The "hair found" inside the product by the customer was not found.As the product has been manipulated, it is not possible to know if the fiber was generated during the process.The product, as it was received, is not conform due to a foreign matter found on the graft.".(4315) no conclusion can be drawn.The product as it was received does not conform to the specification.However, the conducted investigation suggests that the device was not defective at the time of manufacturing.The cause of the event remains unknown since the graft has been manipulated by the user.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 8757537
• Report Number: 1640201-2019-00036
• Device Sequence Number: 19492504
• Product Code: MAL
• UDI-Device Identifier: 00384401018148
• UDI-Public: 00384401018148
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 10/31/2023
• Device Model Number: M00202175208P0
• Device Catalogue Number: M00202175208P0
• Device Lot Number: 18L28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/16/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1