Model Number M00550340 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block e1: the initial reporter healthcare facility is: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
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Event Description
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It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the bronchus during a bronchoscopic balloon dilation procedure performed on (b)(6) 2023.During the procedure, the balloon burst at 8 atm, 12mm.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with a different 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 stable.
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Event Description
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It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the bronchus during a bronchoscopic balloon dilation procedure performed on (b)(6) 2023.During the procedure, the balloon burst at 8 atm, 12mm.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with a different 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 stable.
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Manufacturer Narrative
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The initial reporter healthcare facility is: the fourth affiliated hospital of (b)(4).Imdrf device code (b)(4).Captures the reportable event of balloon burst.Block h10: investigation results the returned cre pulmonary dilatation balloon was analyzed, and a visual examination found that the balloon was burst, and the catheter of the device had no damages.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was confirmed.The results of the analysis performed on the returned device showed that the balloon was ruptured.It is possible that the rupture of the balloon occurred due to procedural factors such as excess of pressure, interaction with other devices like a sharp surface during or previous the procedure, or even the patient's anatomical conditions could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
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Search Alerts/Recalls
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