Catalog Number 80202 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/03/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a: through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
It was reported that during a recanalization procedure, the catheter allegedly stopped after sudden abnormal sound.It was further reported that the tip of the catheter was allegedly found to be separated.Reportedly, the coil spring was allegedly found to be broken.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation and hence physical investigation was not possible.Images were provided for review.The user report and provided image contains information regarding helix break.Therefore, the investigation is confirmed with reported break issue.A clear root cause could not be established.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
|
|
Event Description
|
It was reported that during a thrombectomy and atherectomy procedure in the femoral-popliteal artery via heterolateral femoral popliteal artery, the catheter allegedly stopped after sudden abnormal sound.It was further reported that the tip of the catheter was allegedly found to be separated.Reportedly, the coil spring is found to be broken.The procedure was completed using another device.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|