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Model Number M00547020 |
Device Problems
Difficult to Advance (2920); Failure to Deflate (4060)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.
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Event Description
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It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, there was very strong resistance when the balloon was inserted into the bile duct.The balloon could be inflated without any problem, but could not be deflated, so it was removed from the bile duct by force.The procedure was completed with another extractor pro rx retrieval 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: imdrf device code a140101 captures the reportable event of balloon failure to deflate.Block h10: investigation results.The returned extractor pro rx retrieval balloon was analyzed, and a microscopic and functional inspection found the balloon was not capable of being inflated and deflated due to it was occluded most likely with dry contrast media, to remove the dry contrast media the device was submerged in warm water, and then the device was inspected again but the problem remained.A wire was introduced to see where the device was occluded and then cutting specifically in that location and after the destructive inspection, it was observed that the catheter has a lump of contrast media restricting the capability of the device to have its functionality tested.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon failure to deflate was unable to be confirmed.The results of the analysis performed on the returned device found some dry contrast media inside the catheter and the balloon, restricting the capability of the device to have its functionality tested.Therefore, the most probable root cause is cause not established.
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Event Description
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It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, there was very strong resistance when the balloon was inserted into the bile duct.The balloon could be inflated without any problem, but could not be deflated, so it was removed from the bile duct by force.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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