Device Problems
Use of Device Problem (1670); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an unknown snare was used during a stent removal procedure performed on (b)(6) 2023.During the procedure, the stent became lodged in the working channel, causing the loop of the snare to break away from the wire.The procedure was completed with a olympus 190.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block d4, h4: the suspect device upn and lot number is not reported; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of loop detached.
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Manufacturer Narrative
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Block d4, h4: the suspect device upn and lot number is not reported; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of loop detached.Block d1 and block d2a have been updated based on additional information received august 14, 2023.
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Event Description
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It was reported to boston scientific corporation that an unknown snare was used during a stent removal procedure performed on (b)(6) 2023.During the procedure, the stent became lodged in the working channel, causing the loop of the snare to break away from the wire.The procedure was completed with a olympus 190.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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