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Model Number M00510860 |
Device Problem
Break (1069)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 09/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a complete endoscopic sphincterotomy procedure performed on (b)(6) 2022.During the procedure, the trapezoid rx basket captured a stone.However, the metal sheath tore and there was difficulty removing the device.By force of manipulation, the basket was successfully extracted.The procedure was continued by a new catheterization.Bleeding on the sphincterotomy orifice was noted and a self-expanding metal stent was placed to stop the bleeding.There was an increased procedural time of about 1 hr to 1hr 30 mins.No other patient complications were reported.
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Manufacturer Narrative
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Block h6: patient code e0506 captures the reportable event of major hemorrhage.Device code a0401 captures the reportable event of pull wire break.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the sheath was cut off, the handle cannula was detached from the pull wire and did not return.In addition, the working length was very kinked, and the sheath was buckled/accordion (including coil assembly).The reported event was confirmed.Based on all available information, it is possible that an intense manipulation of device, technique used, or patient's anatomical condition could have contributed to this event.Since the handle and cannula did not return, it was not possible to carry out a more thorough investigation.Therefore, the most probable root cause for the investigation findings is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Event Description
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a complete endoscopic sphincterotomy procedure performed on (b)(6) 2022.During the procedure, the trapezoid rx basket captured a stone.However, the metal sheath tore and there was difficulty removing the device.By force of manipulation, the basket was successfully extracted.The procedure was continued by a new catheterization.Bleeding on the sphincterotomy orifice was noted and a self-expanding metal stent was placed to stop the bleeding.There was an increased procedural time of about 1hr to 1hr 30 mins.No other patient complications were reported.
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Manufacturer Narrative
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Block h6: patient code e0506 captures the reportable event of major hemorrhage.Device code a0401 captures the reportable event of pull wire break.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the sheath was cut off, the handle cannula was detached from the pull wire and did not return.In addition, the working length was very kinked, and the sheath was buckled/accordion (including coil assembly).The reported event was confirmed.Based on all available information, it is possible that an intense manipulation of device, technique used, or patient's anatomical condition could have contributed to this event.Since the handle and cannula did not return, it was not possible to carry out a more thorough investigation.Therefore, the most probable root cause for the investigation findings is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: block h6 component code has been corrected.Block h6 evaluation result code has been corrected.
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Event Description
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a complete endoscopic sphincterotomy procedure performed on (b)(6), 2022.During the procedure, the trapezoid rx basket captured a stone.However, the metal sheath tore and there was difficulty removing the device.By force of manipulation, the basket was successfully extracted.The procedure was continued by a new catheterization.Bleeding on the sphincterotomy orifice was noted and a self-expanding metal stent was placed to stop the bleeding.There was an increased procedural time of about 1hr to 1hr 30 mins.No other patient complications were reported.
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Search Alerts/Recalls
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