Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.A visual inspection found the device returned with the balloon fully detached at both the distal and proximal weld locations.Therefore, the investigation is confirmed for balloon detachment.Additionally, the inner lumen was noted to be stretched.Based on the detachment balloon and stretched inner lumen, the investigation is confirmed for retraction issues.The proximal marker band was returned dislodged on the inner lumen so the investigation is confirmed for dislodgement.The investigation is inconclusive for the reported balloon rupture as no obvious signs of balloon rupture were noted and as the device was unable to be functionally tested due to the detachment.The marker bands likely dislodged as the inner lumen stretched and as the balloon detached distally.It is likely that the balloon detachment resulted in the retraction issues through the sheath.It is also possible that balloon rupture could contribute to retraction issues through the sheath.However, the definitive root cause for the identified balloon detachment or reported balloon rupture could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 09/2021).
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