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Model Number M00565050 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2022 |
Event Type
malfunction
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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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Event Description
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It was reported to boston scientific corporation on may 05, 2022 that a wallflex colonic stent was to be used in the colon to treat an intestinal obstruction during stent implantation procedure performed on (b)(6) 2022.During unpacking and outside patient, the physician noticed that the inner sterile packaging was damaged.The device was not used on the patient.The procedure was completed with another wallflex colonic 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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Block h6: medical device problem code a020503 captures the reportable issue of seal compromised.A wallflex colonic stent and delivery system were received for analysis; the package of the device was not returned.Visual examination of the returned device found the stent was not deployed.The length of the outer clear and blue sheath were measured to be within specification.Microscopic examination revealed the outer clear sheath was kinked.No other issues were noted to the stent and delivery system.The damaged observed to the outer clear sheath were likely due to factors encountered during shipment of the device to the complaint site.It may be how the box was handled or manipulated contributed to the outer clear sheath kinked.Excessive manipulation of the box without enough care could have induced the defect found.The reported event of packaging seal compromised could not be confirmed because packaging of the device was not returned.Due to lack of evidence and without proper evaluation of the packaging, the most probable cause of the reported issue cannot be established.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.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 may 05, 2022 that a wallflex colonic stent was to be used in the colon to treat an intestinal obstruction during stent implantation procedure performed on (b)(6) 2022.During unpacking and outside patient, the physician noticed that the inner sterile packaging was damaged.The device was not used on the patient.The procedure was completed with another wallflex colonic 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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Search Alerts/Recalls
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