Investigation results: a visual examination of the complaint device revealed that there was a hole in front of the device pouch.The package bonds were noted to be continuous and intact.The complaint was likely caused by 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.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.(b)(4).
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It was reported to boston scientific corporation that a cre wireguided dilatation balloon was unpacked on an unknown date.According to the complainant, during unpacking, there were pinhole-like indentations on the device pouch packaging.Reportedly, this device was not used with a patient or procedure.
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