Model Number M00555580 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an acquire needle was used in the liver during an endoscopic retrograde cholangiopancreatography performed on (b)(6), 2023.During the procedure, the needle was flushed with heparin prior to insertion for liver biopsy.The technician noticed black materials flushing out from the tip of the needle.The procedure was completed using another acquire needle.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 a180104 captures the reportable event of foreign material present in device.
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Event Description
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It was reported to boston scientific corporation that an acquire needle was used in the liver during an endoscopic retrograde cholangiopancreatography performed on (b)(6) 2023.During the procedure, the needle was flushed with heparin prior to insertion for liver biopsy.The technician noticed black materials flushing out from the tip of the needle.The procedure was completed using another acquire needle.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Imdrf device code (b)(4) captures the reportable event of foreign material present in device.Investigation results the returned acquire needle was analyzed and showed no visible damage.The stylet was not returned with the device.Based on media analysis of the photo provided by the customer, it is possible to see some black residue.A functional evaluation was performed, and black residue came from inside the needle when the device was flushed.Based on all the information available, the reported event was confirmed.An investigation to address this problem is in progress; therefore, the root cause of the event is conclusion not yet available.Report source has been corrected.
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Search Alerts/Recalls
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