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(b)(4).Based on the product analysis completed on (b)(6) 2018, this product event now meets the criteria for medical device reporting (mdr).Date of event: the event occurred in 2017; however, the month and day were not reported.Procode: krd/hcg.Physical manufacturer name: (b)(4)., dba depuy synthes products, inc.((b)(6)).The product lot number was not reported.Concomitant medical products due to character limitation: 3mm x 6cm deltapaq detachable coil system (dcs) (cdf10030630/unk lot), 5mm x 15cm deltapaq detachable coil system (dcs) (cdf10051530/unk lot).Complaint conclusion: as reported by a healthcare professional, a total of three thermo-mechanical coils, one 3mm x 6cm deltapaq (cdf10030630/unk lot), one 3mm x 8cm deltapaq (cdf10030830/unk lot), and one 5mm x 15cm deltapaq (cdf10051530/unk lot), failed to re-sheath during the procedure.The coils were replaced and the procedure was completed successfully.There was no report of consequence or impact to the patient.No further information was provided.Three devices were returned for this complaint.One of the devices has the embolic coil detached, and the other two are approximately the same length (approximately 15 cm).The devices documented in the complaint are 6 cm long, 8 cm long, and 15 cm long.Since 2 devices are approximately the correct length for cdf10051530/unk lot, none of the devices are demonstrably the correct length for cdf10030630/unk lot or cdf10030830/unk lot, and one of the devices has no attached embolic coil to measure, none of the devices could be clearly associated with any one of the impacted products in the complaint record.Multiple attempts to obtain clarification regarding the returned devices were unsuccessful.Since no further information could be obtained relating any returned item to any of the complaint devices, they were identified as device a, device b, and device c and arbitrarily assigned to the complaint devices for evaluation and conclusion purposes.The 3 devices were evaluated together.All 3 devices were evaluated with respect to the code ¿zipping difficulty-rezipping¿, which was assigned to all 3 products in the complaint.Device b (cdf10030830/unk lot): the distal end of the embolic coil was located in the middle of the green introducer.The embolic coil had protruded from the skive of the translucent introducer sheath.The protruded embolic coil was stretched.The device was almost fully sheathed.There were bends in the device positioning unit (dpu) core wire approximately 86 cm, 95 cm, and 147 cm from the proximal end.The bend at 147 cm from the proximal end was sheathed.The resheathing tool was broken.The length of the embolic coil was estimated with ruler 70007-02ex.While the original embolic coil length could not be determined because the returned embolic coil was stretched and coiled up where it protruded from the skive of the translucent introducer sheath, the embolic coil was at least 12 cm long.The ball tip was intact.There was blood on the embolic coil.The embolic coil was kinked where it exited through the skive of the translucent introducer sheath.The exposed embolic coil was kinked and stretched.The articulating joint was compressed longitudinally.The resistance heating (rh) coil had not heated.While the resheathing tool was broken, its v-notch was undamaged.The device was partially unsheathed and an attempt was made to resheathe the device.The device resheathed successfully until a bend in the translucent introducer sheath was reached approximately 10 cm from the proximal end of the translucent introducer sheath.At this point, the dpu core wire protruded from the skive of the translucent introducer sheath.The lot number of the device is unknown.Without the lot number, manufacturing information cannot be reviewed.The complaint of rezipping difficulty was confirmed.While the device was returned almost fully sheathed, the proximal section of embolic coil was protruding from the skive of the translucent introducer sheath.In addition, when zipping was tested, the dpu core wire protruded from the skive of the translucent introducer sheath.The broken resheathing tool could have contributed to the protrusion of the dpu core wire during functional evaluation.The entire resheathing tool is required to properly unsheathe the device.The translucent introducer sheath passes into the resheathing tool with the dpu core wire and then passes out of the resheathing tool through the side opening.The dpu core wire passes out of the resheathing tool through the proximal end.Sliding the resheathing tool distally along the dpu causes the translucent introducer sheath to be separated from the dpu core wire.In this instance, the resheathing tool is broken at the distal end of the side opening.As a result, sliding the remaining section of resheathing tool distally does not automatically unsheathe the device.In order to test resheathing, the translucent introducer sheath was manually pulled away from the dpu core wire.This is likely to have created a bend in the translucent introducer sheath, which then resulted in the protrusion of the core wire during the resheathing attempt.The protrusion of the embolic coil from the skive of the translucent introducer sheath is evidence that the resheathing tool was passed over the embolic coil while the device was being unsheathed.The 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 inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil will be unsheathed and pass through the resheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.In the returned device, the exposed embolic coil was kinked and stretched.The exposed articulating joint is also damaged.The broken resheathing tool and bends in the dpu core wire are indicative of the application of excessive force to the device, which may have occurred as the resheathing tool was being passed proximally over the exposed embolic coil.This event is likely the cause of the damage to the exposed embolic coil.With review of the device analysis, there is no indication of any manufacturing issues related to the reported event or damages noted on the returned system.Although a definitive conclusion cannot be made, based on the analysis it appears that procedural and handling factors addressed in the instructions for use related to the unsheathing/advancement process may have contributed to the reported failure to re-sheath and damages noted on the returned device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00606.
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As reported by a healthcare professional, a total of three thermo-mechanical coils, one 3mm x 6cm deltapaq (cdf10030630/unk lot), one 3mm x 8cm deltapaq (cdf10030830/unk lot), and one 5mm x 15cm deltapaq (cdf10051530/unk lot), failed to re-sheath during the procedure.The coils were replaced and the procedure was completed successfully.There was no report of consequence or impact to the patient.No further information was provided.
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