MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD WOVEN; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number	M002000196270
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 19j18.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that the doctor of cardiovascular surgery pointed out that there was dirt on the fabric.The corresponding product was not used, and a spare fabric with the same part number was used for surgery.Defective product will be returned.The event occured before surgery and the surgery was not postponed.Complaint (b)(4).
Event or Problem Description
Complaint (b)(4).
Additional Manufacturer Narrative
(10/213) the involved device was returned to intervascular for examination, a visual inspection was performed by the quality assurance (qa) manager, the qa supervisor and two quality control technicians.It was concluded that the product is conform.Please note that the stains reported correspond to collagen which is, by design, part of the product coating.It as a known phenomenon where collagen is translucent at the time of manufacturing and turns yellow over time.(67) the conducted investigation concludes that the product is conform to the specification.

• Brand Name: HEMASHIELD WOVEN
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• 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: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 16121435
• Report Number: 1640201-2023-00002
• Device Sequence Number: 12395465
• Product Code: DXZ
• UDI-Device Identifier: 00384401018827
• UDI-Public: (01)00384401018827
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: M002000196270
• Device Catalogue Number: M002000196270
• Device Lot Number: 19J18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Prefer Not To Disclose