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Model Number M00570610 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The wallflex biliary stent has not been received for analysis.Upon receipt and completion of the device analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex biliary rx uncovered stent was to be implanted in the bile duct to treat a 3.5cm biliary obstruction during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the wallflex biliary stent deployed prematurely and 2/3 of the stent was still inside the scope.The wallflex biliary stent was removed together within the scope and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Event Description
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It was reported to boston scientific corporation on june 22, 2022 that a wallflex biliary rx uncovered stent was to be implanted in the bile duct to treat a 3.5cm biliary obstruction during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the wallflex biliary stent deployed prematurely and 2/3 of the stent was still inside the scope.The wallflex biliary stent was removed together within the scope and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: medical device problem code a150103 captures the reportable event of wallflex biliary stent deployed prematurely.Block h10: the wallflex biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer clear sheath was accordioned near the tip.No other issues were noted to the delivery system.The damage observed to the delivery system was most likely due to procedural factors.It may be that the lesion characteristics, handling of the device, the technique used by the user, and/or normal procedural difficulties encountered during the procedure, limited the performance of the device, and contributed to outer sheath accordioned.However, the reported event of stent prematurely deployed could not be confirmed.This problem occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
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Search Alerts/Recalls
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