Model Number BML-V442QR-30 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/18/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information is not yet available for this event.There are two associated medwatches submitted for the two devices of this event with patient identifiers (b)(6) (first device) and (b)(6) (second device).This medwatch is for the patient identifier (b)(6).The device is returned but the device evaluation is not yet completed.As such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
|
|
Event Description
|
As reported by the customer, the device distal tip, where the plastic piece is and the guidewire is inserted, broke during an unknown therapeutic procedure.A second device was opened and the tip of the second device also broke.The procedure was completed with a third similar device.The tips of neither device fell into the patient.There is no reported harm or adverse impact to the patient.
|
|
Manufacturer Narrative
|
This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
|
|
Search Alerts/Recalls
|