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Manufacturer¿s ref.No: (b)(4).Information regarding patient weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.A review of manufacturing documentation associated with this lot (l16397) 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.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.Additional information will be submitted within 30 days of receipt.
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The healthcare professional reported that during the embolization procedure targeting an aneurysm that is 3.5mm in width and 5.5mm in length on the posterior communicating artery (pcom) with mild vessel tortuosity, the first two loops of the 3.00mm x 6.00cm galaxy g3 mini coil (glm930060 / l16397) were placed into the aneurysm and the coil was advanced, the next coil loop would not form/break and it pushed the concomitant sl-10® 45° tip microcatheter (stryker) back.The physician felt that the coil was defective, and he attempted to remove the coil and it became hung up within the microcatheter.Part of the coil was still in the aneurysm; the physician tried to advance the coil and retrieve it again and the coil became prematurely detached from the delivery wire at the detachment zone.The physician then removed the microcatheter with the detached coil.A new microcatheter and coil were used, and the procedure was successfully completed.There was no report of any patient adverse event or complication.
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the embolization procedure targeting an aneurysm that is 3.5mm in width and 5.5mm in length on the posterior communicating artery (pcom) with mild vessel tortuosity, the first two loops of the 3.00mm x 6.00cm galaxy g3 mini coil (glm930060 / l16397) were placed into the aneurysm and the coil was advanced, the next coil loop would not form/break and it pushed the concomitant sl-10® 45° tip microcatheter (stryker) back.The physician felt that the coil was defective, and he attempted to remove the coil and it became hung up within the microcatheter.Part of the coil was still in the aneurysm; the physician tried to advance the coil and retrieve it again and the coil became prematurely detached from the delivery wire at the detachment zone.The physician then removed the microcatheter with the detached coil.A new microcatheter and coil were used, and the procedure was successfully completed.There was no report of any patient adverse event or complication.Additional information was requested from the sales representative on (b)(6) 2020.The information provided is as following: the embolic coil did become fracture and separated as the physician was trying to take it out of the aneurysm and the coil became stuck in the microcatheter causing the premature detachment.The coil did appear stretched as part of the premature detachment.Heparinized saline was running through the line with the pressure bag to ensure continuous flush was maintained.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3.00mm x 6.00cm galaxy g3 mini coil and the concomitant sl-10® 45° tip microcatheter were returned contained in a pouch.Visual inspection was performed on the returned device.The device positioning unit (dpu) was observed kinked.A microscopic inspection was performed.The marker band was found at 40.9cm from the distal end.This is within specification.The coil was observed strained / stretched and fragmented.Only part of the coil was found.The concomitant microcatheter was inspected and part of the coil was found in the microcatheter with residues of dried blood.A review of manufacturing documentation associated with this lot (l16397) 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 complaint documented that during the embolization procedure targeting a 3.5mm x 5.5mm pcom aneurysm with mild vessel tortuosity, after the first two loops of the 3.00mm x 6.00cm galaxy g3 mini coil were placed into the target lesion, the coil was further advanced but the next loop would not form.As a result, the concomitant microcatheter was pushed back.The physician attempted to remove the coil when it became hung up within the microcatheter with part of the coil still in the aneurysm.During the attempt to advance the coil to retrieve it, it became prematurely detached from the delivery wire at the detachment zone.The microcatheter and coil were removed.The embolic coil component of the returned device was stretched, part of the coil was found in the concomitant sl-10® 45° tip microcatheter.There were also residues of dried blood noted on the portion of the coil that was in the concomitant microcatheter.Additional information received on 17 september 2020 indicated that the embolic coil did become fracture and separated as the physician was trying to take it out of the aneurysm and the coil became stuck in the microcatheter causing the premature detachment as reported.The coil did appear stretched as it became prematurely detached.There was heparinized saline was running through the line with the pressure bag to ensure continuous flush was maintained.The issues reported in the complaint were confirmed.The stretched and fractured conditions of the embolic coil were confirmed with the additional responses provided by the sales representative on 17 september 2020.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched and fractured conditions of the coil in this complaint were due to the attempt to remove the coil from the aneurysm as the coil became stuck in the microcatheter.Applied force during procedural handling also resulted in the observed kinked dpu.Heparinized saline was delivered through the line with the pressure bag to ensure that adequate and continuous flush was maintained, however, the residues of dried blood suggest that the amount of flush may not have been enough.This may have been a contributing factor to the issue encountered during the attempt to withdraw the coil.Positioning difficulty is also a known potential issue associated with the use of the device.Characteristics of the target aneurysm can factor into the positioning of the coil loop when it is in the target position.Two coil loops were already in the aneurysm when the physician encountered difficulty with the formation of the subsequent coil loop.It is possible that the two loops already in position within the aneurysm and the aneurysm characteristics may have resulted in the difficulty in the formation of the subsequent loop.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.Additional information will be submitted within 30 days of receipt.
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