Model Number GWH3505R |
Device Problem
Unraveled Material (1664)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/14/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned to olympus for evaluation.In addition, insufficient information was provided by the user facility.Multiple follow ups were made by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.The cause of the event cannot be determined at this time.However, the instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire." inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc.Carefully and slowly withdraw the guidewire from the patient to avoid any damage.The tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating material be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.¿.
|
|
Event Description
|
Olympus was informed that during procedure, the doctor had placed a urology stent and when the doctor went to remove the device it became caught on the stent and the device became ¿unwound¿.There was no injury reported.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide the results of the dhr review.A review of the dhr for the concerned device showed that the production has been done according to the valid specifications.There were no irregularities or deviations found during the manufacturing of the device.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide the device evaluation results.A visual inspection of the received condition noted that the distal pebax tip remained attached to the coil which was stretched off over the fractured corewire.The corewire was fractured at approximately 20mm from the distal tip at approximately 0.0065" diameter.The distal 30mm of the failed corewire remained within the pebax tip was intact, undamaged and firmly attached to the failed section of the corewire.The proximal sleeve and coil section were intact over the corewire with the coil secured at the transition.Based on the evaluation and similar reported events, the most probable cause can be attributed to overloading.The initial point of failure likely occured at the distal pebax tip section adjacent to the coil transition.Procedural details were not provided, however, the ultratrack's prebax tip likely became unbound within a deployed stent while attempting to retract the ultratrack guidewire.Continued retraction force applied to the ultratrack while attempting to remove the guidewire within a deployed stent likely resulted in the tensile failure of the corewire within the prebax tip.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to make a correction on the aware date.
|
|
Search Alerts/Recalls
|