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Catalog Number DF8006SC |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Pseudoaneurysm (2605)
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Event Date 06/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2027).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
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Event Description
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It was reported that three months post a surgical graft placement procedure, graft material allegedly had a hole.It was further reported that the patient allegedly experienced pseudoaneurysm.The current status of the patient was unknown.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported material puncture/hole issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 08/2027), g3, h6 (method).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that three months post-surgical graft placement procedure, graft material allegedly had a hole.It was further reported that the patient allegedly experienced pseudoaneurysm.Furthermore, attempt was made at endovascular repair of the pseudoaneurysm, but the defect appeared to be too proximal for comfortable coverage with a stent graft.Reportedly, pseudoaneurysm was resected and as the entire graft was extremely well incorporated, so interposition was performed using a fusion bioline graft to the distaflow, and the graft-graft anastomosis stented with a covered stent graft.The current status of the patient was unknown.
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Search Alerts/Recalls
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