Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported perforation is a known risk associated with malleable penile prosthesis implant procedures and is noted as such in the tactra instructions for use.Device history record (dhr): review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the tactra instructions for use (ifu) was reviewed.Perforation was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.
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It was reported that the patient experienced both proximal and distal perforations during a procedure to implant a tactra malleable penile prosthesis.Initial dilation was completed and the physician attempted to insert a 13 mm device but was not able to fit it in the corpora.The physician began downsizing the implant until the nitinol core became exposed and elected to implant an alternate 11 mm device instead.When sizing the 11 mm implant, the cylinders were trimmed until the nitinol core was exposed once more.The physician continued to trim the cylinders to a length of 12 cm with a 1 cm rear tip extender and was able to successfully place the implant.Per the physician, it was during the process of attempted implant and eventual insertion of the implants that the perforations occurred due to stiffness of the cylinders.It was noted that no additional intervention was required to treat the perforations.No additional patient complications were reported.
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