Catalog Number XXX- BACTISEAL CATHETER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Type
Injury
|
Manufacturer Narrative
|
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Event Description
|
In the literature article, " surgical management of giant retrocerebellar arachnoid cysts with a cystoventricular stent after long-term." by amir kershenovich, sheela vivekanandan, xin s.Xin and caitlin davenport.It was reported that one patient out of the five had surgical complications with the codman bactiseal ventricle catheter.Per the article: "background: outcomes of surgical treated patients with giant retrocerebellar arachnoid cysts with the available typically preferred techniques frequently are unsatisfactory.Objectives: we hypothesized that a pressure gradient may exist between the cyst and the ventricular system that may be responsible for the posterior fossae-related symptoms and headaches, and, if so, that connecting both cavities by means of a shunt catheter (i.E., cystoventricular stent), the pressure differences would equilibrate and the symptoms resolve.To prove our hypothesis, we decided to simultaneously monitor the intracyst pressure and the intraventricular pressure.Methods: this was a retrospective chart review analysis of 5 consecutive patients with giant retrocerebellar arachnoid cysts treated between 2014 and 2016.Results: four patients underwent 3 days of continuous intracranial pressure monitoring, and 1 patient was monitored in the surgical suit.Cyst and ventricular pressures tended to be within normal accepted values in all patients, and a pressure gradient was noticed only in the 2 patients with previous cyst surgeries.All patients were treated with a cystoventricular stent, and overall, had long-term sustained good outcomes, with resolution of symptoms in 3 and significant improvement in 2.Conclusions: patients with symptomatic large retrocerebellar arachnoid cysts do not seem to have increased intracranial pressure, and regardless of the presence or absence of a pressure gradient between the cyst and the ventricles, a cystoventricular stent seems to be effective and the best first surgical option to offer.Patient harm: patient 5, age (b)(6) female, had surgical complications.The patient had ventricle catheter malposition and thalamic hemorrhage.There were no reports of product malfunction.
|
|
Manufacturer Narrative
|
Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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.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 (b)(4) 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)(6), director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
|
|
Search Alerts/Recalls
|
|