Model Number M00516920 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2015 that a wallflex partially covered esophageal stent was received by the customer on (b)(6) 2015.According to the complainant, upon inspection, the device packaging was damaged and the sterile seal was compromised.No visible damages were noted to the stent system.There was no patient or procedure involved.
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Manufacturer Narrative
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A wallflex partially covered esophageal stent was returned inside its packaging tray and inner pouch for analysis; however, the outer box was not returned.Visual examination of the returned device found that the manufacturing seal of the inner pouch was open; however, there was evidence of a seal along this end of the pouch.It was noted that the vendor seal was intact.No issues were noted with the profile of the device or the packaging tray.Device analysis determined that the condition of the returned device was consistent with the complaint incident as the manufacturing seal of the inner pouch was open.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping.Therefore, the most probable root cause is handling damage.
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Event Description
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It was reported to boston scientific corporation on (b)(4) 2015 that a wallflex partially covered esophageal stent was received by the customer on (b)(6) 2015.According to the complainant, upon inspection, the device packaging was damaged and the sterile seal was compromised.No visible damages were noted to the stent system.There was no patient or procedure involved.
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Manufacturer Narrative
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Reported event of seal compromised.The device has been received for analysis; however, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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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Search Alerts/Recalls
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