Catalog Number 80202 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/08/2023 |
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide 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 pending return.
|
|
Event Description
|
It was reported that during a recanalization procedure, while pulling back the catheter, the guidewire allegedly got broken in the catheter inside the patient's body.It was further reported that the middle of the guidewire allegedly got detached.Reportedly, the guidewire was snared.There was no reported patient injury.
|
|
Event Description
|
It was reported that during a recanalization procedure, while pulling back the catheter, the guidewire allegedly got broken in the catheter inside the patient's body.It was further reported that the middle of the guidewire allegedly got detached.Reportedly, the guidewire was snared.There was no reported patient injury.
|
|
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: manufacturing review: a manufacturing review for the catheter was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation and a guidewire and a catheter were physically investigated.During physical investigation, it was noted that catheter was delivered with the guidewire inside.The guidewire was broken at 43 cm from the tip of it.The test guidewire passed though until the gearwheel and after running in the water slightly lower than nominal aspiration level was achieved.No further physical damages were found.Therefore, the investigation is confirmed for the reported guidewire break.A clear root cause could not be identified but a damaged guidewire 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.H10: g3.H11: d4(medical device lot number), h6 (method, result, conclusion).H11: section a through f ¿ the information provide 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 : see h10.
|
|
Search Alerts/Recalls
|
|