MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD WOVEN DOUBLE VELOUR CARDIOVASCULAR FABRIC; 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	08/27/2021
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.(4109/213) the device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.(3331/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.(4102/213) one retention sample from an another sterilization lot, coating on the same day with the same coating parameter as the involved device, was visually inspected by the qa supervisor on (b)(6) 2021.His conclusion is as follows: "no stain was found on the two faces of the patch." (11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Details of the problem: scheduled to be used as a patch during heart surgery at the above facility on (b)(6) 2021.When i took it out of the box, i saw something like a stain on the surface.The staff asks for analysis on suspicion of product defects.Other than the relevant part is used, and there is no effect on surgery.I will attach a photo of the product.Case, place of use : a patch was used in the lumen of the left chamber in left ventricular reduction.Request for future response: we will return the unused part, so we request a close examination and analysis.Are there any reports on the same lot? is it possible to check safety at the same lot? also, have there been similar bug reports in the past? we request a letter for the customer with the contents such as.Complaint #(b)(4).
Additional Manufacturer Narrative
Corrected data : on block d2b : the product code was corrected.(10/4247) fragment of the patch was returned to intervascular for examination and was visually inspected by the quality assurance supervisor and two experienced operators.The conclusions of the inspection are as follows: "the stains on the extremity of the patch are not conform : these stains should not have passed and would have been normally stopped at the stages following the quality control.They may come from the intervention." (4315) no conclusion can be drawn on the exact origin of the defect.The conducted investigation suggests that the device was not defective at the time of manufacturing.However, the product, as it was returned to intervascular, does not conform to the specification.The product having been opened and manipulated by the user it is not possible to rule on the origin of the event.We remain very attentive, if this type of event occurs again.
Event or Problem Description
See mfg report(s): 1640201-2021-00031.Complaint #: (b)(4).

• Brand Name: HEMASHIELD WOVEN DOUBLE VELOUR CARDIOVASCULAR 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: philip gaillard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 12546867
• Report Number: 1640201-2021-00031
• Device Sequence Number: 16422320
• 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
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2022
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2025
• Device Model Number: M002000196270
• Device Catalogue Number: M002000196270
• Device Lot Number: 20F10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose