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Model Number M0063903200 |
Device Problems
Difficult to Open or Close (2921); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a rigid laser ureterolithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was inspected and found it was able to straighten.However, when the device was inserted into the patient, the coil failed to close in a spiral when activated to catch a stone.Several attempts were made but all were unsuccessful.The device was removed, and the procedure was not completed as a result of this event.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.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 h6: problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: visual analysis of the returned device found the white inner working length was torn and accordioned.This prevented the blue outer sheath from being able to retract and expose the coil entirely.The reported complaint of the device being unable to close into a coil was confirmed.Based on all available information, it is likely that excessive force during handling was applied while testing the device before the procedure, which caused the white inner working length to tear and accordion when inserted into the scope.This prevents the coil from being able to be used effectively.The instructions for use (ifu) warns against using excessive force when resistance is encountered while attempting to withdraw the coil.Therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.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 stone cone nitinol retrieval coil was used in the ureter during a rigid laser ureterolithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was inspected and found it was able to straighten.However, when the device was inserted into the patient, the coil failed to close in a spiral when activated to catch a stone.Several attempts were made but all were unsuccessful.The device was removed, and the procedure was not completed as a result of this event.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.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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