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

Model Number M002000196270

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

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 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 Description

Complaint (b)(4).

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
• Type of Device: 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
• MDR Text Key: 308715454
• Report Number: 1640201-2023-00002
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00384401018827
• UDI-Public: (01)00384401018827
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M002000196270
• Device Catalogue Number: M002000196270
• Device Lot Number: 19J18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Sex: Prefer Not To Disclose