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Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Preliminary photo images of the complaint device were captured by the j&j (b)(4)affiliates and included in the complaint file on 29 july 2021.The photos were reviewed by the product analysis lab and is documented below.[photo analysis]: based on the photos provided, it can be determined that the embolic coil component of the 3mm x 4cm galaxy g3 xsft coil has several areas where the coil is in stretched and tangled condition.The coil is still attached to the resistance heating (rh) coil.The distal outer sheath of the rh coil did not show evidence of softening; indicating that the rh coil had not been heated.The device positioning unit (dpu) can be observed kinked.No other additional damage was observed.The reported issue in the complaint that the coil introducer on the 3mm x 4cm galaxy g3 xsft coil was damaged could not be confirmed based on the photos provided.There were no damage observed on the coil introducer sheath.The reported issue related to the failure to detach also could not be evaluated based on the photos provided.Further investigation will be performed once the device returns for analysis.A review of the manufacturing documentation associated with this lot (l16036) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This is one of two (2) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00322.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 coil embolization procedure with the target at the anterior communicating artery (acom), the physician prepped the device in accordance with the instructions for use (ifu).It was confirmed that the connecting cable was energized.It was reported that the 3mm x 4cm galaxy g3 xsft coil (glx120304 / l16036) failed to detach.It was replaced with another coil and the replacement coil was used without any issue.On 19 july 2021, additional information was received, the information indicated that the introducer sheath of the 3mm x 4cm galaxy g3 xsft coil was also damaged.During the same procedure, a 1.00mm x 2.00cm galaxy g3 mini coil (glm910020 / 30513162) was used as a finishing coil, but this coil also failed to detach.It was removed from the coil mass and the procedure was reported as completed without issues.There was no report of any patient adverse event or complication.Preliminary photo images of the complaint device were captured by the j&j (b)(4)affiliates and included in the complaint file on (b)(6) 2021.
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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 23 august 2021.[additional information]: the healthcare professional reported that during a coil embolization procedure with the target at the anterior communicating artery (acom), the physician prepped the device in accordance with the instructions for use (ifu).It was confirmed that the connecting cable was energized.It was reported that the 3mm x 4cm galaxy g3 xsft coil (glx120304 / l16036) failed to detach.It was replaced with another coil and the replacement coil was used without any issue.On 19 july 2021, additional information was received, the information indicated that the introducer sheath of the 3mm x 4cm galaxy g3 xsft coil was also damaged.During the same procedure, a 1.00mm x 2.00cm galaxy g3 mini coil (glm910020 / 30513162) was used as a finishing coil, but this coil also failed to detach.It was removed from the coil mass and the procedure was reported as completed without issues.There was no report of any patient adverse event or complication.Preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file on 29 july 2021.The photos were reviewed by the product analysis lab.Based on the photos provided, it can be determined that the embolic coil component of the 3mm x 4cm galaxy g3 xsft coil has several areas where the coil is in stretched and tangled condition.The coil is still attached to the resistance heating (rh) coil.The distal outer sheath of the rh coil did not show evidence of softening; indicating that the rh coil had not been heated.The device positioning unit (dpu) can be observed kinked.No other additional damage was observed.The reported issue in the complaint that the coil introducer on the 3mm x 4cm galaxy g3 xsft coil was damaged could not be confirmed based on the photos provided.There were no damage observed on the coil introducer sheath.Further investigation will be performed once the device returns for analysis.On 23 august 2021, additional information was received.The information indicated that it is not known what malfunction was associated with the introducer sheath of the 3mm x 4cm galaxy g3 xsft coil.The microcatheter used was the sl-10® microcatheter (stryker).It was not known if the same microcatheter were used for both coils.A pre-deployment electrical check was performed.All connections appeared to fit properly without application of excessive force.The reported event did not result in a clinically significant procedure "delay".The procedure was completed when the complaint devices were removed from the coil mass.E.1: initial reporter phone: +(b)(6).This is one of two (2) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00322 and 3008114965-2021-00361.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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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 a coil embolization procedure with the target at the anterior communicating artery (acom), the physician prepped the device in accordance with the instructions for use (ifu).It was confirmed that the connecting cable was energized.It was reported that the 3mm x 4cm galaxy g3 xsft coil (glx120304 / l16036) failed to detach.It was replaced with another coil and the replacement coil was used without any issue.On 19 july 2021, additional information was received, the information indicated that the introducer sheath of the 3mm x 4cm galaxy g3 xsft coil was also damaged.During the same procedure, a 1.00mm x 2.00cm galaxy g3 mini coil (glm910020 / 30513162) was used as a finishing coil, but this coil also failed to detach.It was removed from the coil mass and the procedure was reported as completed without issues.There was no report of any patient adverse event or complication.Preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file on 29 july 2021.The product analysis lab reviewed the photos.Based on the photos provided, it can be determined that the embolic coil component of the 3mm x 4cm galaxy g3 xsft coil has several areas where the coil is in stretched and tangled condition.The coil is still attached to the resistance heating (rh) coil.The distal outer sheath of the rh coil did not show evidence of softening; indicating that the rh coil had not been heated.The device positioning unit (dpu) can be observed kinked.No other additional damage was observed.The reported issue in the complaint that the coil introducer on the 3mm x 4cm galaxy g3 xsft coil was damaged could not be confirmed based on the photos provided.There were no damage observed on the coil introducer sheath.On 23 august 2021, additional information was received.The information indicated that it is not known what malfunction was associated with the introducer sheath of the 3mm x 4cm galaxy g3 xsft coil.The microcatheter used was the sl-10® microcatheter (stryker).It was not known if the same microcatheter were used for both coils.A pre-deployment electrical check was performed.All connections appeared to fit properly without application of excessive force.The reported event did not result in a clinically significant procedure delay.The procedure was completed when the complaint devices were removed from the coil mass.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3mm x 4cm galaxy g3 xsft coil was returned contained in a pouch.Visual inspection was performed.The device positioning unit (dpu) was observed kinked at 16 inches from the proximal end.This is consistent with the preliminary photo images of the complaint device, which showed that the dpu was kinked.The embolic coil is observed protruding from the introducer.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection was performed.Under magnification, the embolic coil was observed to be in stretched condition while protruding from the introducer.This observation is consistent with the preliminary photo images of the complaint device that were captured by the j&j japan affiliates.The photos showed that the 3mm x 4cm galaxy g3 xsft coil has several areas where the coil is in stretched and tangled condition.The embolic coil was still attached to the rh coil which did not show evidence of softening.This indicated that the rh coil had not been heated.Functional test was performed.The resistance of the device was measured with a multimeter.The initial resistance was measured to be 53.1 o; this is within the specification range of 48.5 o ¿ 56.0 o.The device was connected to a lab sample detachment control box dcb2000500 (dcb) with a lab sample enpower control cable and the power was turned on.The system ready light illuminated.The detach button was pressed and the embolic coil was immediately detached.A review of the manufacturing documentation associated with this lot (l16036) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint reported that during the embolization procedure, the 3mm x 4cm galaxy g3 xsft coil was prepped in accordance with the ifu, it was confirmed that the connecting cable was energized, but the complaint coil failed to detach.Additional information also indicated that the introducer sheath of the complaint device was damaged, but it was not known what the malfunction was associated with the introducer sheath.The returned device underwent visual inspection and the dpu was observed kinked and the embolic coil was protruding from the introducer.The observations may be related to the reported issue with the damaged introducer sheath reported in the complaint.Based on the observations, the reported issue with the damaged introducer sheath was confirmed.Functional evaluation was performed.The resistance of the complaint device was measured and confirmed to be within the specification range.The complaint device was connected to lab samples dcb and enpower control cable.When the power was turned on, the system ready light illuminated and the embolic coil detached without issue when the detach button was pressed.The reported issue that the complaint device failed to detach was not confirmed through the functional analysis of the returned complaint device.There may have been other factors during the procedure that may have resulted in the reported failure to detach issue; these factors cannot be replicated during the functional testing in the laboratory environment.Coil stretching is known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue as stretching from occurring.The coil stretched condition observed in the photo of the complaint device but was not originally reported in the complaint.Stretching can occur during procedure handling where force may have been inadvertently applied.The exact cause of the observed stretched condition could not be conclusively determined; however, it may have been the result of inadvertent force that may have been applied during the procedure that resulted in the coil in the observed stretched condition.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 3mm x 4cm galaxy g3 xsft coil left the manufacturing facility with the embolic coil in stretched condition and protruding from the introducer as noted during the visual and microscopic inspections.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil as described in the following section, re sheathing the microcoil system, and replace with a new microcoil system.Do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.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 code ¿no device problem found¿ code was used in investigation findings to indicate that the issue reported related to the failure to detach issue reported in the complaint was not confirmed.The code ¿no problem detected¿ was used in investigation conclusions is corresponding to the code ¿no device problem found.¿ this is one of two (2) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00322 and 3008114965-2021-00361.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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