Catalog Number 821676 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Injury (2348)
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Event Date 08/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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It was reported that the device was implanted on (b)(6) 2016 and explanted on (b)(6) 2019.Fragments in right pulmonary artery.
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Manufacturer Narrative
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Additional information received: medwatch report (b)(4): "a young patient with history of right porencephalic cyst with communication to his ventricular system & subsequent shunted hydrocephalus.In past, he failed both ventriculoperitoneal shunt (vps) & ventriculopleural shunt due to pseudocyst formation/ malabsorption.Most recent shunt revision was conversion to right side ventriculoatrial shunt.Patient was evaluated through physical medicine clinic & had x-rays to evaluate for potential scoliosis, which incidentally revealed that ventriculoatrial shunt had fractured with tubing dislodge into his left pulmonary artery branch.Echo showed fragment of catheter in left pulmonary artery.A few weeks later, cardiology removed the fragmented piece successfully in cath lab." between (b)(6) 2019 and (b)(6) 2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period (b)(6) 2019 through (b)(6) 2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
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Event Description
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N/a.
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Manufacturer Narrative
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Complaint sample was not returned to codman therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Udi (b)(4).Manufacturing date 24th november 2014.Expiration date: 30th november 2016.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
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Search Alerts/Recalls
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