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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number IGW0030-30
Device Problems Flaked (1246); Product Quality Problem (1506); Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2023
Event Type  malfunction  
Event Description
It was reported to intervascular that when an intergard woven straight graft 30cm x 30cm was prepared for use, the customer noticed that it was not suitable for use due to the color change observed on the graft.In addition, it was reported that a hair was observed on the graft.¿ moreover, it was reported that particles in the graft were spilled.The customer wanted to prevent the spillage by cutting a portion of it.However, the particles continued to fall out from the cut parts.
 
Manufacturer Narrative
(10/3233) it was reported that the product is available.Currently, the shipping process is ongoing.A visual product inspection is scheduled.(4109/3233) the review of historical data indicated that one other similar complaint (b)(6) was reported by the same customer for the same sterilization lot number 21h19 and at the same date.Refer to initial mdr mfg report #(b)(4).The investigation is still ongoing.(3331/213) the device history records review concluded that there was no non conformance/planned deviation in relation with the event (11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.Evaluation anticipated but not yet begun.
 
Manufacturer Narrative
(10/4248) the involved device was returned to intervascular.A visual inspection was performed by two quality control (qc) technicians.They observed that the returned product has been manipulated and cut.The observation results were analyzed by the quality assurance supervisor, who concluded that given the condition of the returned graft, it is not possible to investigate further.(4109/213) the review of historical data indicated that another similar complaint (b)(4) about stain on the graft for lot number 21h19 was reported by the same customer and at the same date.The investigation findings of complaint #(b)(4).Concluded that the involved device was in compliance with the product specifications.(4315/19) based on the investigation findings, no conclusion can be drawn on the exact origin of reported incident.Following the inspection results of returned device, it was observed that the customer had handled and cut the product.Considering its condition, it is not possible to determine the cause of the customer's observation and no further investigation can be carried out.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.
 
Event Description
Complaint #(b)(4).
 
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Brand Name
INTERGARD WOVEN STRAIGHT
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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 Key16975686
MDR Text Key316008565
Report Number1640201-2023-00013
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00384401000266
UDI-Public(01)00384401000266
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K984294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/07/2023
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
Device Operator Health Professional
Device Model NumberIGW0030-30
Device Catalogue NumberIGW0030-30
Device Lot Number21H19
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/27/2023
Initial Date FDA Received05/22/2023
Supplement Dates Manufacturer Received07/03/2023
Supplement Dates FDA Received07/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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