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(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the product lot number of the device is not available / not reported.[conclusion]: the healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting a basilar artery (ba) tip aneurysm, the pulserider aneurysm neck reconstruction device (anrd) (catalog / lot# unknown) was being delivered for implantation first using the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown), but there was resistance felt at the distal part and it was difficult to be handled.The microcatheter was replaced with a 45 tip 150cm x 5cm prowler select plus microcatheter (606s255fx / 30545428) but the resistance was worse than with the first microcatheter; and the pulserider became stuck.The priming was done without any issue.It was reported that the pulserider device was replaced with another device and the physician used the first microcatheter (606s255x) with the replacement device to complete the procedure.There was no report of any patient adverse event or complication.The complaint documented that the device is not available to be returned for evaluation and analysis.During the same procedure, the 6mm x 15cm galaxy g3 coil (gly120615 / 30401372) was used as the framing coil, but it did not fit the lesion.The concomitant sl-10® microcatheter (stryker) kicked back, therefore, the coil had to be resheathed but it could not be resheathed.There was no report of any patient adverse event or complication.The complaint documented that the devices are not available to be returned for evaluation and analyses.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.In addition, without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00311, 3008114965-2021-00312.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a pulserider-assisted coil embolization procedure targeting a basilar artery (ba) tip aneurysm, the pulserider aneurysm neck reconstruction device (anrd) (catalog / lot# unknown) was being delivered for implantation first using the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown), but there was resistance felt at the distal part and it was difficult to be handled.The microcatheter was replaced with a 45 tip 150cm x 5cm prowler select plus microcatheter (606s255fx / 30545428) but the resistance was worse than with the first microcatheter; and the pulserider became stuck.The priming was done without any issue.It was reported that the pulserider device was replaced with another device and the physician used the first microcatheter (606s255x) with the replacement device to complete the procedure.There was no report of any patient adverse event or complication.The complaint documented that the device is not available to be returned for evaluation and analysis.During the same procedure, the 6mm x 15cm galaxy g3 coil (gly120615 / 30401372) was used as the framing coil, but it did not fit the lesion.The concomitant sl-10® microcatheter (stryker) kicked back, therefore, the coil had to be resheathed but it could not be resheathed.There was no report of any patient adverse event or complication.The complaint documented that the devices are not available to be returned for evaluation and analyses.
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 15 september 2021.[additional information]: the healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting a basilar artery (ba) tip aneurysm, the pulserider aneurysm neck reconstruction device (anrd) (catalog / lot# unknown) was being delivered for implantation first using the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown), but there was resistance felt at the distal part and it was difficult to be handled.The microcatheter was replaced with a 45 tip 150cm x 5cm prowler select plus microcatheter (606s255fx / 30545428) but the resistance was worse than with the first microcatheter; and the pulserider became stuck.The priming was done without any issue.It was reported that the pulserider device was replaced with another device and the physician used the first microcatheter (606s255x) with the replacement device to complete the procedure.There was no report of any patient adverse event or complication.The complaint documented that the device is not available to be returned for evaluation and analysis.During the same procedure, the 6mm x 15cm galaxy g3 coil (gly120615 / 30401372) was used as the framing coil, but it did not fit the lesion.The concomitant sl-10® microcatheter (stryker) kicked back, therefore, the coil had to be resheathed but it could not be resheathed.There was no report of any patient adverse event or complication.The complaint documented that the devices are not available to be returned for evaluation and analyses.On 15 september 2021, additional information was received.The information indicated that no further information was provided on the catalog and lot number of the pulserider anrd.The lot number of the first microcatheter used with the pulserider anrd could not be obtained.The pulserider anrd was used with the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) but it was in the second microcatheter, a 45 tip 150cm x 5cm prowler select plus microcatheter (606s255fx / 30545428) that the pulserider anrd got stuck in.Continuous flush was maintained through both microcatheters.No information was available about the pulserider anrd replacement device that was used with the first microcatheter, the 150cm x 5cm prowler select plus microcatheter (606s255x) to complete the procedure.The additional information also indicated that there was no difficulty positioning the 6mm x 15cm galaxy g3 coil (gly120615 / 30401372) in the target site; no difficulty getting the coil to conform to the aneurysm wall.The coil was still attached to the delivery system when it was removed.No damage was observed on the coil used in this procedure.There was no clinically significant delay in the procedure due to the reported issue.E.1: initial reporter phone: (b)(6).This is one of three products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00311 and 3008114965-2021-00312.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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