Product analysis #: 705010735: equipment used: video inspection system (m-81805), ruler (m-83360), pin gauge sets (m-84083, m-84081), camera (panasonic lumix dmc-zs5), in-house 0.0160¿ mandrel drawing(s) referenced: dwgsfg11xxx-yyyy-zz rev.F as found condition: the phenom-17 micro catheter were returned for analysis within a shipping box and within two resealable plastic biohazard pouches.The unknown non-medtronic guidewire used in the event was not returned for analysis.Visual inspection/damage location details: no damages were found with the phenom-17 micro catheter hub.The phenom-17 micro catheter was found kinked at ~0.4cm from the distal end.The distal tip and marker band was found intact.Testing/analysis: the phenom-17 micro catheter total length was measured to be ~158.5cm and the usable length was measured to be ~151.0cm, which is within specification (specification: total (ref) = 156.5cm, usable: 150cm ± 5cm).The phenom-17 micro catheter inner diameter was measured to be 0.017¿at both ends, which is within specification.The micro catheter was flushed with water; however, water did not exit the distal end as the catheter was found occluded.An in-house 0.0160¿ mandrel was inserted into the phenom-17 micro catheter hub, through the catheter and became stuck at ~4.3cm from the proximal end.The catheter was cut, and damaged inner liner was found to occlude the stuck location.The mandrel was inserted into the distal end of the micro catheter and resistance was encountered at the kinked location.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter occlusion¿ and ¿catheter resistance¿ were confirmed.The cause of the resistance and occlusion was found to be the damaged inner liner.The cause of the damage could not be determined.Possible causes for damage are incompatible guidewire, advancing the guidewire against resistance, or device not hydrated prior to use.As the unknown guidewire used in the event was not returned for analysis, any contribution of the guidewire towards resistance and catheter occlusion could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The distal micro catheter was found kinked, which potentially could contribute towards resistance and damage.Possible causes for catheter kink are patient vessel tortuosity, guidewire/delivery system removed aggressively, incompatible guidewire, catheter entrapment or user advances device against resistance.Ngod10 2022-07-10 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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