Model Number M00558220 |
Device Problems
Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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Premarket / 510(k) #: k163248 & k151895.
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Event Description
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It was reported to boston scientific corporation that an expect pulmonary needle was used in the #4r, #7 and #4l lymph nodes in the trachea during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2022.During the procedure, the distal tip of the needle detached inside the patient after puncture.The tip was not removed since they could not find it.The procedure was completed using another expect pulmonary needle.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block g4: premarket / 510(k) #: (b)(6).Block h6: device problem code a0501 captures the reportable event of needle detachment.Block h10: investigation results: the returned expect pulmonary needle was analyzed.The visual evaluation found that the needle broke off and it was observed bent.The broken part of the needle was not returned.In addition, the working length was observed kinked.During microscope inspection, the broken end of the needle had an irregular shape/bent.No other problems were noted.The reported event was confirmed.Product analysis identified that the needle was bent before the break, this bent could have led the break, and this bent could have been caused by some technique applied by the customer during the procedure and/or some interaction within another device could have also contributed on this issue, once the needle was bent some tough movement could have caused the break off.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure.
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Event Description
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It was reported to boston scientific corporation that an expect pulmonary needle was used in the #4r, #7 and #4l lymph nodes in the trachea during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2022.During the procedure, the distal tip of the needle detached inside the patient after puncture.The tip was not removed since they could not find it.The procedure was completed using another expect pulmonary needle.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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