INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Model Number IGW0030-30 |
Device Problems
Flaked (1246); Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2023 |
Event Type
malfunction
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Event Description
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¿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.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.¿.
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Manufacturer Narrative
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(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for visual inspection.(4109/3233) the review of historical data indicated that one other similar complaint b)(6) was reported by the same customer with the same sterilization lot number 21h19 and at the same date.Refer to initial mdr report 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.
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Event Description
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Complaint #(b)(4).
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Manufacturer Narrative
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Corrected data: on block h6, the medical device problem code "1246" was removed following the testing results of involved device as described below.(10/213) the involved device was returned to intervascular.A visual inspection was performed by two quality control (qc) technicians.The observation results were analyzed by the quality assurance supervisor, who concluded that the stained appearance observed throughout the length of the product, is attributed to collagen, which is accepted in regard to the current acceptance and rejection standards applied during the qc inspection.(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) suggested that the product was not defective at the time of manufacturing.(67) the conducted investigation concludes that the returned product is in compliance with the product specifications.
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