Model Number M00558790 |
Device Problems
Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code: a0402, captures the reportable event of a balloon burst.
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Event Description
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It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a procedure performed on (b)(6) 2024.During the procedure, the balloon burst.The procedure was completed with a different model device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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Event Description
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It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a procedure performed on (b)(6) 2024.During the procedure, the balloon burst.The procedure was completed with a different model device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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Manufacturer Narrative
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Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h10: investigation results the returned cre pro gi wireguided dilatation balloon was analyzed, and it was found that the balloon had a pinhole located approximately at 14 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure 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.Block h11: additional information: block e1 (initial reporter first name).
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Search Alerts/Recalls
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