Model Number M00550320 |
Device Problems
Burst Container or Vessel (1074); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 cre pulmonary dilatation balloon was used in the airway during a diagnostic bronchoscopy procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon ruptured around 2 atm.The procedure was completed with another cre pulmonary balloon.There were no patient complications reported as a result of this event.
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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 airway during a diagnostic bronchoscopy procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon ruptured around 2 atm.The procedure was completed with another cre pulmonary balloon.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter of the device did not have any damages.The balloon had some friction marks in the distal side.Functional evaluation was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located in the distal section on the body of the balloon.This does not confirm the reported event of balloon burst; however, the pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.The pinhole problem is likely due to factors encountered during the procedure, such as the interaction between the balloon and the scope or any other surface during the procedure that could have created friction, resulting in the found failure of balloon pinhole.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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