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Model Number M00565050 |
Device Problems
Break (1069); Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex colonic stent was to be implanted in the sigma-colon to treat a stenosis during a colonoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, resistance was felt during attempted stent deployment and the handle of the stent delivery system broke.The stent was fully covered by the outer sheath when removed from the patient.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
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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 problem 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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Manufacturer Narrative
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Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the wallflex enteral colonic stent and delivery system were returned for analysis.The stent was received fully covered and undeployed.Visual examination of the returned device found the outer clear sheath was kinked, the outer blue sheath was detached from the hub and the stainless steel handle was returned kinked and broken.A dimensional inspection of the delivery system was performed and found the length of the blue sheath was out of specification.Functional inspection could not be performed due to the broken handle.No other issues were noted to the stent and delivery system.The reported event of handle break and stent failure to deploy were confirmed.The damages noted of the returned device were most likely due to procedural factors encountered during the procedure.It may be that handling of the device, the techniques used by the user, tortuous anatomy and normal procedural difficulties, limited the performance of the device and contributed to the reported and observed failures.It is possible that factors and/or conditions related to patient anatomy during the use of the device could have affected its performance and its intended purpose.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.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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Event Description
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It was reported to boston scientific corporation on february 18, 2022 that a wallflex colonic stent was to be implanted in the sigma-colon to treat a stenosis during a colonoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, resistance was felt during attempted stent deployment and the handle of the stent delivery system broke.The stent was fully covered by the outer sheath when removed from the patient.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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