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Product complaint #
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> (b)(4).Based on the product damage reported on 10/15/2018, this event meets the required criteria for mdr reporting.Information regarding patient date of birth, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(4).Lot - the product lot number provided - c35483 - does not belong to a presidio coil from catalog number pc410062630.Therefore, the correct lot number is unknown at this time.Clarification has been requested.Concomitant med products due to character limitation: prowler select plus (606s255x/17674174) microcatheter (b)(6).(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2018-00778, & 3008114965-2018-00779.
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As reported by a healthcare professional, during a coil embolization of an anterior communicating artery aneurysm, the user encountered resistance while advancing the 6mm x 26cm presidio 10 cere (pc410062630/c35483), 7mm x 30cm presidio 10 cere (pc410073030/s10163), and the 7mm x 20cm micrusphere xl (ssr10072020/s13782) through the proximal shaft of the prowler select plus (606s255x/17674174) microcatheter.The issue required that the coils be removed and replaced.The same microcatheter was used to complete the procedure.No patient complications occurred as a result of the event.The procedural delay was less than 30 minutes.The devices were prepped and used according to the instructions for use (ifu).An adequate continuous flush was maintained through the microcatheter.No visible product damage was noted prior to the event.The concomitant microcatheter did not kink or bend at any time.A 10mm x 34cm presidio coil and competitor coils were used successfully with the concomitant microcatheter prior to and following the encountered resistance.Additional information received indicated that the distal portion of the 6mm x 26cm presidio embolic coil was kinked, the distal portion of the 7mm x 30cm presidio embolic coil was stretched, and the distal portion of the 7mm x 20cm micrusphere embolic coil was bent when the products were removed from the patient.The complaint products will be returned for analysis.The concomitant microcatheter is not available for return.No further information was provided.
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Product complaint # (b)(4).[complaint conclusion] as reported by a healthcare professional, during a coil embolization of an anterior communicating artery aneurysm, the user encountered resistance while advancing the 6mm x 26cm presidio 10 cere (pc410062630/s10208), 7mm x 30cm presidio 10 cere (pc410073030/s10163), and the 7mm x 20cm micrusphere xl (ssr10072020/s13782) through the proximal shaft of the prowler select plus (606s255x/17674174) microcatheter.The issue required that the coils be removed and replaced.The same microcatheter was used to complete the procedure.No patient complications occurred as a result of the event.The surgery was delayed less than 30 minutes due to the event.The devices were prepped and used according to the instructions for use (ifu).An adequate continuous flush was maintained through the microcatheter.No visible product damage was noted prior to the event.The concomitant microcatheter did not appear damaged.A 10mm x 34cm presidio coil and competitor coils were used successfully with the concomitant microcatheter prior to and following the encountered resistance.Additional information received indicated that the distal portion of the 6mm x 26cm presidio embolic coil was kinked, the distal portion of the 7mm x 30cm presidio embolic coil was stretched, and the distal portion of the 7mm x 20cm micrusphere embolic coil was bent when the products were removed from the patient.No further information could be obtained.The 6mm x 26cm presidio 10 was returned with its original label, which matched the complaint information.Kinks were observed on the device positioning unit (dpu) core wire approximately 59 cm and 90 cm from the proximal end of the device.The distal end of the embolic coil was seen in the translucent introducer.The dpu core wire was seen protruding from the introducer skive.The resheathing tool was seen slightly bent.The introducer proximal to the resheathing tool had a very short length and could not be pulled out without tweezers.The device was inspected under a microscope.The embolic coil distal ball tip was present and intact.The embolic coil was seen undamaged with no kinks.The proximal end of the embolic coil was seen pressed into the distal end of the distal outer sheath, damaging the articulating joint.The v-notch of the resheathing tool was seen damaged as there was a fracture that progressed down its center indicating that the device was not properly unlocked.An attempt was made to advance the device, but the coil was impeded in the introducer sheath.Pressure from the dpu side of the joint was translated into motion of the embolic coil towards and against the wall of the introducer, creating friction and impeding progress.A review of manufacturing documentation associated with lot s10208 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported customer complaint that the embolic coil was kinked/bent was not confirmed.No damage was seen on the embolic coil.The reported customer complaint of resistance/friction during advancement through the microcatheter could not be confirmed since the coil was impeded in the introducer.The coil could not advance through the introducer because of the damage to the articulating joint; therefore, its ability to advance through a microcatheter could not be tested.However, since description of coil damage was reported by the customer, the device had initially exited the introducer to visualize the embolic coil.When manufactured, the two components of the articulating joint are aligned.Pressure from the dpu side of the joint is translated into motion of the embolic coil straight through the introducer.In this case, the embolic coil was slightly offset and angled away from the joint.Pressure from the dpu side of the joint is translated into motion of the embolic coil towards and against the wall of the introducer, creating friction and impeding progress.The concomitant microcatheter used in the procedure was not returned for failure analysis.There is not enough information to identify the cause of the observed failure.However, it is likely that excessive force was applied to the device.The articulating joint was compressed, indicating that force was applied while the device was prevented from advancing.100% of devices are inspected in-process for the ability to advance through the introducer and retract back, as well as inspection at the articulating joint.Damage to the articulating joint sufficient to prevent advancement of the embolic coil would be observed at this inspection.Thus, it is unlikely that the observed issue was present when the device left the manufacturing facility.Resistance/friction during advancement and damage to the embolic coil are known potential product failures associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Per the ifu, ¿if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve,and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.Loosen the rhv main valve and fully re insert the introducer tip into the infusion microcatheter hub.Gently tighten the rhv main valve around the introducer sheath to prevent backflow of blood.Visually inspect the alignment of the introducer tip and the microcatheter hub to ensure they have not slipped apart.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.¿ the returned device does not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and the evidence presented by the sample article; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure.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.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2018-00777, 3008114965-2018-00778, & 3008114965-2018-00779.
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