As reported by the field, during a coil embolization, a 3mmx8cm deltapaq cere coil (cdf10030830, s11444) was being used as the second coil.The physician didn't like the shape of the coil deployment and decided to pull it out.During resheathing the coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.
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Product complaint # = > pc-(b)(4).Updated sections on this report: d10, g4, g7, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, a 3mmx8cm deltapaq cere coil (cdf10030830, s11444) was being used as the second coil.The physician didn't like the shape of the coil deployment and decided to pull it out.During resheathing the coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.A non-sterile unit deltapaq cere 3mmx8cm was received inside of a pouch.The device was inspected, and it was found that the dpu is kinked at 165 cm from proximal, also the introducer was not returned with the device.The embolic coil was inspected under a microscope and it was found with a stretch condition.No other damages or anomalies were observed during the microscopic inspection.The functional analysis could not be performed due to the introducer was not returned with the rest of the device.A manufacturing record evaluation was performed for the finished device s11444 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - zipping difficulty-rezipping¿ could not be evaluated due the introducer was not returned with the rest of the device, also during the microscopic inspection, it was noted that the embolic coil has a stretched condition.This condition could be related to the customer¿s complaint; however, this cannot be conclusively determined.Based on the findings during the analysis, the customer¿s complaint was confirmed.The complaint reported by the customer ¿coil - positioning difficulty-poor conformability¿ could not be evaluated because the event is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.The stretch condition noted on the embolic coil may have been related with compliant reported by the customer, however, this cannot be conclusively determined.The stretched condition noted on the embolic coil could be related with the event, the embolic stretch appears to might have been caused by excessive force and handling is applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.The ifu also instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
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