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Model Number M0061902230 |
Device Problems
Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteroscopy procedure in the ureter.The event date was not reported.During the procedure, while inserting the stent inside the patient, the stent was accordion and split from the sensor wire when it became bound.The stent was completely removed as one piece from the patient.The procedure was successfully completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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Search Alerts/Recalls
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