The used device was returned for evaluation with original product packaging.Ref and lot numbers were verified for this product.Visual inspection found the spring tip on the device to be damaged and was partially unwound near the proximal end of the spring joint between the spring and guidewire, which may indicate excess tensile force applied to the spring.Potential causes of the damage may be deterioration of the spring tip joint caused by overuse of the device, as well as excessive force during cleaning, handling, and use of the device.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.Risk assessment found this issue to be consistent with current risk documents.Due to breakage and detachment of the guidewire spring tip a process verification was performed and no issues were found.This failure mode is mitigated during manufacturing by a 100% pull force test of the joint between the spring and guidewire.A historical review of complaint data revealed (b)(4) similar complaints of which (b)(4) devices were confirmed in the past two years.In the same timeframe (b)(4) units have been sold worldwide, making the rate of occurrence of this (b)(4) percent.The instructions for use advise the user of the following.Since the marked guidewire is a reusable device that is subjected to varied use and cleaning environments, the life span of the product cannot be guaranteed.In particular, less than (b)(4) of the spring tips have been reported to have become dislodged during reuse or cleaning.Dislodgement of the spring tip during use may require endoscopic removal of the spring tip." carefully inspect the guidewire after each use.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Inspect the soldered joints and discard the wire if the soldered joints appear discolored, loose or cracked.Avoid using excessive force on the wire and spring top while cleaning.Do not bend or twist the spring tip as it may cause the soldered joints to deteriorate.Since the marked guidewire is a reusable device that is subject to varied use and cleaning environments, the life span of the product cannot be guaranteed.This issue will continue to be monitored through the complaint system to assure patient safety.
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