Device evaluation under a microscope, slight bunching is noted at the proximal balloon bond.The balloon returned partially inflated.Both marker bands are visible and intact.A 10ml syringe was filled with water and connected to the guidewire port and attempted to flush but resistance was noted, and the device was unable to be flushed.A 0.014¿ guidewire from the lab was front loaded via the tip and a blockage was noted at approx.12.5cm proximal to the distal tip.The guidewire was loaded via the gw port of the luer and became stuck at the same location in the catheter.This was possibly due to contrast or biologic within the guidewire lumen.An indeflator was connected to the device and an attempt was made to inflate the balloon to nominal pressure (7atm) and rated burst pressure (15atm) however the balloon failed to inflate.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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