Product analysis: the nanocross device was returned to medtronic investigation lab for evaluation.Also returned with the device was the label card which indicated that the returned device was a 4.0mm nanocross elite.No ancillary devices or images returned for evaluation.The returned device was a 4.0 x 150mm.Nanocross elite catheter.A red blood-like substance was noted within the y-manifold, catheter, and balloon chamber.The balloon was received in a post-inflation profile.Inspection of the device revealed that the blue inner guide wire lumen was outside of the outer assembly/balloon.A 10cc syringe was attached to the proximal hub and the guide wire lumen was flushed, a red liquid, consistent with blood was observed exiting the lumen.A 0.014¿ guide wire was then loaded through the lumen, no resistance was encountered during advancement of the guide wire.The 10cc syringe was then attached to the inflation port of the manifold and the balloon chamber was inflated.The proximal initiation point of the longitudinal tear was noted during inflation.The tear initiated approximately 11.3cm proximal to the catheters distal tip and continued to the end of the balloon assembly.The balloon was flushed/cleaned, and the tear was inspected microscopically.It was noted that the distal bond remained intact.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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