Catalog Number 80202 |
Device Problems
Detachment of Device or Device Component (2907); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2024 |
Event Type
malfunction
|
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: 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: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2026).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 via crossover approach, the device allegedly had no aspiration.It was further reported that the catheter was allegedly dislocated.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 catheter was returned for evaluation and it was physically investigated.During physical investigation, the test guidewire was not able to pass through the metal gearwheel.After working in the water nominal aspiration level was achieved.The reported mechanical jam can be confirmed.A detachment of the catheter was not observed during investigation and therefore, can not be confirmed.Therefore, the investigation is confirmed for the reported mechanical jam issue.However, the investigation is inconclusive for the reported detachment issue.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.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.
|
|
Event Description
|
It was reported that during a thrombectomy and atherectomy procedure in the superficial femoral artery via the crossover approach, the device alleged had no aspiration.It was further reported that the catheter was allegedly dislocated.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|