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Model Number M00569690 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation on december 15, 2021 that a wallstent biliary rx partially covered stent was to be implanted to treat a malignant stenosis in the upper common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the stent deployed prematurely.The stent was removed from the patient and the procedure was completed with another wallstent biliary stent.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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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 december 15, 2021 that a wall stent biliary rx partially covered stent was to be implanted to treat a malignant stenosis in the upper common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2021.During the procedure, the stent deployed prematurely.The stent was removed from the patient and the procedure was completed with another wallstent biliary stent.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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Medical device problem code a150103 captures the reportable event of stent prematurely deployed.A wallstent biliary rx partially covered stent and delivery system were received for analysis.The stent was received fully deployed.Visual inspection found the outer clear sheath was kinked.The outer sheath at the gas section was inspected and the inner sheath was found misaligned with the outer sheath.Also, the gas ramp was found lifted.No other issues with the stent and delivery system were noted.The reported event of stent premature deployment could not be not confirmed as this failure occurred during the procedure and could not be functionally/visually verified.It is most likely that procedural factors encountered during the procedure limited the performance of the device.Handling and manipulation of the device during procedure could have caused the observed damages of the device.However, there is no indication of what the customer reported because the stent was returned completely deployed and the reported event could not be functionally/visually verified.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Search Alerts/Recalls
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