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Model Number M00558440 |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during esophageal procedure performed on (b)(6)2022.During preparation, it was noticed that the balloon was leaking liquid after injecting the liquid.The procedure was completed with another cre wireguided dilatation balloon.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.
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Manufacturer Narrative
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(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found the balloon had a pinhole, which confirms the reported event.The guidewire of the device was noted to be bent.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section on the body of the balloon.It is possible that interaction with any surface during the procedure could create friction on the balloon, causing the balloon leak during the procedure.Additionally the guidewire bent likely occurred due to the manipulation of the catheter during the procedure.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.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as the balloon was pre-inflated.
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Event Description
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It was reported to boston scientific corporation that a cre balloons - wireguided was used in the esophagus during esophageal procedure performed on (b)(6) 2022.During the procedure, it was noticed that the balloon was leaking liquid after injecting the liquid.The procedure was completed with another cre balloons - wireguided device.There were no patient complications reported as a result of this event investigation results revealed that the balloon had a pinhole and the device was used in the esophagus; therefore, this is now an mdr reportable event per (b)(4), dilatation balloons pinholes quality plan.
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Manufacturer Narrative
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Block h2: correction: block h6 (device codes) and block h10 (additional mfr narrative) block h6: device code a041001 captures the reportable investigation result of balloon pinhole.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found the balloon had a pinhole, which confirms the reported event.The guidewire of the device was noted to be bent.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section on the body of the balloon.Based on the evidence, it was reported that the physician pre-inflated the balloon before inserting in the working channel, this can provoke the pinhole found in the balloon, this problem can occur due to misuse of the ifu.Taking all available information into consideration, the most probable root cause is failure to follow instructions, since it was determined that the problems with the device can be traced to the user not following the manufacturer instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as the balloon was pre-inflated.
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Search Alerts/Recalls
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