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Model Number BG UNK |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Dysfunction (2019); Post Operative Wound Infection (2446); Blood Loss (2597); Pseudoaneurysm (2605); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Multiple attempts for additional information were made without success.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
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Event Description
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According to the publication "bovine serum albumin-glutaraldehyde (bioglue) tissue adhesive versus standard renorrhaphy following renal mass enucleation: a retrospective comparison", retrospective review to compare operative and post-operative outcomes between patients who underwent tumor-bed closures with sutures compared with bioglue tissue sealant only.Methods - 507 patients met criteria 255 sealant group vs 252 suture group.Baseline characteristics showed similar distribution of the analyzed parameters.Rates of intraoperative and post-operative complications was not significantly different between both groups.In a table in the paper it lists the following complications: intraoperative complication: pleural injury - 9.Postoperative complication pulmonary -1.Urinary obstruction -1.Wound infection -1.Pseudoaneurysm -1.Other -2.
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Manufacturer Narrative
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Multiple requests to the publication author for additional clarifying information were made without success to acquire the following information: the dates of implant, any adverse events that occurred, lot numbers of the bioglue, amount of bioglue used, and the current status of the patients.No response was received. manufacturing records for the bioglue used in the study were not reviewed as lot numbers were not provided.The system could not be queried for potential lots shipped to the hospital as dates of implant were not provided.A review of the publication was performed.The rate of intraoperative and postoperative complication was not significantly different between both groups.The only intraoperative complication in the bioglue group was pleural injury.Postoperative complications were pulmonary (n=1), urinary obstruction (n=1), wound infection (n=1), pseudo aneurysm (n=1) and other unknown complications (n=2).All complications with the exception of wound infection occurred at a similar rate as in the suture group.This leads us to conclude that the root cause of the reported complications is more likely associated with the surgery itself and not with the use of bioglue.The publication conclusion indicates that closing the tumor bed with bioglue tissue adhesive is feasible, safe, can shorten ischemia time, and potentially reduce transfusion rate.The ifu lists vessel obstruction, injury to normal vessels or tissue as potential complications associated with the use of bioglue.This event does not identify additional hazards or modify the probability and severity of existing hazards.
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Event Description
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According to the publication "bovine serum albumin-glutaraldehyde (bioglue) tissue adhesive versus standard renorrhaphy following renal mass enucleation: a retrospective comparison", retrospective review to compare operative and post-operative outcomes between patients who underwent tumor-bed closures with sutures compared with bioglue tissue sealant only.Baseline characteristics showed similar distribution of the analyzed parameters.Rates of intraoperative and post-operative complications was not significantly different between both groups.In a table in the paper it lists the following complications: intraoperative complication: pleural injury - 9.Postoperative complication: pulmonary -1, urinary obstruction -1, wound infection -1, pseudoaneurysm -1, other -2.
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Search Alerts/Recalls
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