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

Model Number	M002000196240
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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.(4109/3233) the review of historical data indicated that one other similar complaint (#1131040) was reported by the same customer, involving nine other products with same product reference and from the same lot number 24f19.There were reported to fda via 9 emdrs from #1640201-2024-0000016 to #1640201-2024-0000024 already submitted.The investigation is still ongoing.(11/213) two retention samples were selected from the same sterilization lot number with the same fabric type (woven) and the same coating parameters as the involved product.A visual inspection of the retention samples was performed by a qualified quality control technician and the team manager.It was concluded that the product is in compliance with the product specifications.(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 a hemashield patch had the same "water marks" on the fabric issue as the other 9 patches with the same reference (m002000196240) and from the same lot number (24f19).The patch was never opened or used on a patient, and was requested to return it for a replacement.
Additional Manufacturer Narrative
(10/213) the involved device was returned to intervascular.A visual inspection was performed by the team lead of quality control, production supervisor and the quality assurance supervisor.The inspection results are the following: the patch sn (b)(6) was received sealed and was opened during the inspection.The patch showed slight yellow and shiny collagen marks without thickening.It was concluded that the inspected device is conform to the product specifications.(4109/213) the review of historical data indicated that another similar complaint (#(b)(4), mfg 9 emdrs from #1640201-2024-0000016 to #1640201-2024-0000024) about stain on the patch was reported by the same customer on a different date for nine other patches from lot number 24f19.The investigation of complaint #(b)(4) concluded that the products are in compliance with the product specifications.(67) the conducted investigation concludes that the returned product is in compliance with the product specifications.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: HEMASHIELD WOVEN DOUBLE VELOUR FABRIC
• 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: 20618946
• Report Number: 1640201-2024-0000027
• Device Sequence Number: 7553751
• Product Code: DXZ
• UDI-Device Identifier: 00384401018810
• UDI-Public: (01)00384401018810
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K955349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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 Model Number: M002000196240
• Device Catalogue Number: M002000196240
• Device Lot Number: 24F19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown