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Model Number M00510880 |
Device Problems
Separation Failure (2547); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block d4, h4: the complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f2301 captures the reportable event of another device was used to rescue the situation.
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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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a stone, however, upon trying to crush the stone, the device failed to break, and the handle failed to open again to release the stone.Another device was used to rescue the situation.The procedure was completed with a different device.There were no patient complications a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Block d4 (lot number and expiration date) and h4 has been updated based on additional information received on june 15, 2023.Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f2301 captures the reportable event of another device was used to rescue the situation.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection noted that the handle cannula was detached and was not returned.The working length was detached in two parts.The thumb ring shows stress marks.The proximal section of the sheath was torn.The pull wire was separated from the working length, kinked, and detached from the cannula.The tip of the basket was detached and not returned.The distal and proximal screw depth were measured and found within specification.The basket was returned without the tip, suggesting that it could be released as expected.Therefore, the reported event of tip failure to separate and basket failure to release stone was not confirmed.However, the device was returned with multiple damages.Based on all available information, it is most likely that procedural factors and handling of the device affected its performance.The stress marks on the thumb ring are evidence of over manipulation.It is possible that due to the size of the stone while attempting to crush it could have led to the marks on the thumb ring and the damaged to the sheath.Additional force applied to the device could have ended detaching the handle cannula and the pull wire, and as consequence kinking it.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during procedure and the device had no influence on event.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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a stone, however, upon trying to crush the stone, the device failed to break, and the handle failed to open again to release the stone.Another device was used to rescue the situation.The procedure was completed with a different device.There were no patient complications a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Search Alerts/Recalls
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