Model Number HGKAX0808 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
Event Type
Injury
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Event Description
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It was reported to intervascular that a hemagard knitted graft appeared to be misshaped.Ill fitted.It was explanted an another graft had to be used.The device not used.The hemagard graft was beveled, and anastomosed to the common femoral and onto the sfa with a running 5-0 prolene suture.At which time they attempted to flush the graft and kept getting resistance.Multiple attempts made to straighten it out but was deemed inadequate and would not hold its shape.The surgery was not delayed because of the event since they had a second one on the shelf ready for use.
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Manufacturer Narrative
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It was indicated that the device is available, the device will be returned to intervascular for examination.The analysis is pending.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21k14.The device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.A retention sample from same sterilization lot 21k14 and coated on the same day and under the same conditions as the involved device was selected.A visual inspection will be performed by the qa supervisor.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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Event Description
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See mfg initial report 1640201-2022-00025.Complaint #(b)(4).
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Manufacturer Narrative
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Code (10) is replaced by code (4115).(4115) it was initially indicated that the device was available to be returned.However, the information was received that the product was discarded by accident by the hospital and thus irretrievably lost for testing.(11/213) a visual inspection has been performed by the qa supervisor on the retention sample.His observations are as follows: "the graft shows no abnormalities, the embossing is regular.It reacts correctly when handled.No non-conformity related to the event described in complaint #(b)(4) was observed on this product.It complies with the specifications." (4118/3233) more information is being sought regarding the event.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.H3 other text: 4115 - the actual device involved in the adverse event had been discarded by accident by the hospital and thus irretrievably lost for testing.
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Event Description
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Complaint #(b)(4).
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Manufacturer Narrative
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(4119/213) more details about the event description was requested to the surgeon, unfortunately no relevant information was received.It should be noted that the product reference affected was already ordered by the hospital.(4112/213) the case and its investigation have been reviewed by the medical affairs manager who concluded that based on the limited information provided in this complaint record and without knowing the surgical details regarding the implantation of the intergard (hemagard) vascular graft, it is difficult to ascertain the exact cause of the misshaping of graft or the cause of the resistance during flushing of the graft.(4315) the investigation concluded that no conclusion can be drawn since the product was discarded and the limited information provided.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.
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Search Alerts/Recalls
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