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| Model Number 201-D |
| Device Problems
Unstable (1667); Separation Failure (2547)
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| Patient Problems
Aneurysm (1708); Hemostasis (1895); Perforation (2001); No Code Available (3191)
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| Event Date 09/07/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.A review of manufacturing documentation associated with this lot (w3471-05) 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.Failure to detach, device movement, recapture difficulty, and aneurysm perforation are known potential procedural complications associated with the pulserider anrd.Per the pulserider instructions for use (ifu): when the implant is in position and deployed at the desired location, ensure the microcatheter has been sufficiently retracted to allow the implant to unsheath fully.Verify the implant is fully deployed by confirming that the delivery wire marker is distal to the microcatheter tip marker.Place the coil delivery microcatheter through the pulserider implant and into the sac of the aneurysm.Proceed carefully with coiling the aneurysm.The pulserider implant should remain attached to the delivery wire until a sufficient basket of coils has been placed within the aneurysm to prevent the pulserider implant from being unintentionally advanced into the aneurysmal sac.Use fluoroscopy to confirm that the implant has remained in the desired position and that the delivery wire marker is distal to the microcatheter tip (this ensures that the predetermined delivery wire detachment zone is exposed and ready for detachment).The physician reportedly attempted to detach the anrd without exposing the predetermined delivery wire detachment zone from the concomitant microcatheter.Assignment of root cause remains speculative and inconclusive; however, it appears that clinical and procedural factors may have contributed to the reported event.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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Event Description
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The healthcare professional reported that during the stent-assisted coil embolization procedure targeting a basilar tip aneurysm, the pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / w347105) was deployed and the first coil (unspecified brand) was placed inside the target aneurysm, when the pulserider detachment controller showed an error when the physician attempted to detach the device.The controller was rebooted but the error remained.The controller and accessory cables (prdsacd / 30393939) were replaced but the same issue continued.The physician suspected the possibility of device detachment and attempted to remove the device, but the pulserider device ¿fell down because it was not able to be detached.¿ the physician attempted to resheath the pulserider device, but the coiling catheter was ¿in the inside, so the pulserider strut was as if it sandwiched the microcatheter and became stuck.¿ the physician noticed the situation with the catheter and attempted to unlock the catheter by slightly retracting the pulserider device, but the pulserider device ¿jumped into the aneurysm¿ and bleeding was confirmed on subsequent imaging.Hemostasis was achieved when heparin was reversed.Subsequent verification of the recording revealed that the pulserider was not in the ¿proper exposure state¿ before the physician attempted the detachment, the physician recognized this issue as user error.The procedure will be re-attempted in two weeks.Additional information was received on 14 september 2020.The information indicated that at the time of the incident, one coil was inside the aneurysm, and the pulserider device was being manipulated.Neither the coil nor the pulserider device were detached at the time of the reported event, even though there were multiple attempts to detach the pulserider device were made.After the discovery of the rupture, the coil and the pulserider device were both removed.The coil was initially wrapped around one arch of the pulserider device, but the physician was able to free the coil from the device.No products were left inside the patient.It was reported that the patient will be brought back on (b)(6) 2020 for another attempt to implant the coils and the pulserider.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the slide presentation of the detachment test of a sample pulserider device.The test was performed by the japan pulserider product team.The presentation was included in the complaint on 02 october 2020.The test included four conditions: 1) with the pulserider fully retracted into the prowler select plus microcatheter; 2) only with the body markers exposed; 3) exposed to the leg; 4) delivery wire moarkers are exposed.The result was that only condition 4 passed; conditions 1 to 3 failed.The slide presentation was reviewed by the product analysis lab.A monopolar circuit was configured with saline solution; tested catheter position when pushing the button.1.Pulserider fully covered with microcatheter; twice.2.Until core exposed; 3 times.3.Just until anchor marker exposed.All tests resulted in the shedding process failure.Except for when the until anchor marker exposed, in this position the detachment process was successful.A review of manufacturing documentation associated with this lot (w3471-05) 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.Further investigation is pending the evaluation and analysis of the returned device.Updated sections: g.4, g.7, h.2, h.6, and h.10.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 Narrative
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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.The device was received on 23 september 2020 for evaluation.The product investigation and analysis were completed on 07 october 2020.The investigational finding is documented below.[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization procedure targeting a basilar tip aneurysm, the pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / w3471-05) was deployed and the first coil (unspecified brand) was placed inside the target aneurysm, when the pulserider detachment controller showed an error when the physician attempted to detach the device.The controller was rebooted but the error remained.The controller and accessory cables (prdsacd / 30393939) were replaced but the same issue continued.The physician suspected the possibility of device detachment and attempted to remove the device, but the pulserider device ¿fell down because it was not able to be detached.¿ the physician attempted to resheath the pulserider device, but the coiling catheter was ¿in the inside, so the pulserider strut was as if it sandwiched the microcatheter and became stuck.¿ the physician noticed the situation with the catheter and attempted to unlock the catheter by slightly retracting the pulserider device, but the pulserider device ¿jumped into the aneurysm¿ and bleeding was confirmed on subsequent imaging.Hemostasis was achieved when heparin was reversed.Subsequent verification of the recording revealed that the pulserider was not in the ¿proper exposure state¿ before the physician attempted the detachment, the physician recognized this issue as user error.The procedure will be re-attempted in two weeks.Additional information was received on 14 september 2020.The information indicated that at the time of the incident, one coil was inside the aneurysm, and the pulserider device was being manipulated.Neither the coil nor the pulserider device were detached at the time of the reported event, even though there were multiple attempts to detach the pulserider device were made.After the discovery of the rupture, the coil and the pulserider device were both removed.The coil was initially wrapped around one arch of the pulserider device, but the physician was able to free the coil from the device.No products were left inside the patient.It was reported that the patient will be brought back on 25 september 2020 for another attempt to implant the coils and the pulserider.Additional information received on 01 october 2020.The information indicated that the heparin reversal stopped the bleeding.When the detachment button was pressed, the error appeared and remained on the display.It was reported that when switching on the detachment system power switch, a self-test of all indicators was performed ¿ green and red flashes with both leds.When switched on, the battery indicator remained constantly lit indicating a charged battery.When the start button was pressed, a steady acoustic signal emitted and the steady red indicator displayed signifying unsuccessful cycle initiation.The steady acoustic signal emitted with flashing red indicator display (interrupt cycle, open circuit) when the detachment cycle was initiated.The pulserider accessory cable was reported as an impacted product because the physician wants to confirm that the product was functioning as expected and without anomaly.It was confirmed that there was proper connection between the detachment power supply and the delivery wire or patient¿s groin (return electrode).The concomitant microcatheter functioned as intended.Additional information received on 04 october 2020 indicated that the patient was successfully re-treated with a pulserider 8t device on (b)(6) 2020 without any complication.Investigation summary: a non-sterile pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device was received contained in a pouch.Visual inspection was performed.It was observed that the introducer is separated from the rest of the device and was without any damages.No other damage was observed during the visual inspection.A microscopic inspection was performed.The pulserider device was observed in good, normal condition under microscopic magnification.Functional evaluation: a lab sample detachment controller was prepared for the detach cycle, the returned concomitant pulserider accessory cable was connected to the detachment controller.The black cable was connected to a suitable conductive electrode and immersed in saline solution.The red cable was connected to the proximal end of the returned pulserider t, 3mm, 8mm arch and immersed in saline solution.The detach button was pressed and the green light began flashing; then the green light remained illuminated and the implant was detached.A review of manufacturing documentation associated with this lot (w3471-05) 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.The complaint documented that during the stent-assisted coil embolization procedure targeting a basilar tip aneurysm, the pulserider t, 3mm, 8mm arch arnd had detachment issue, was unstable and was difficult to recapture.The recapture issue could not be confirmed.The device was received with the introducer separated from the device; this condition would prevent the device from undergoing functional testing for the reported re-capturability of the device as reported in the complaint.The issue related to the stability of the device was not confirmed as it is dependent on the procedure and the patient¿s anatomy at the time the issue encountered.The product analysis lab cannot replicate the environment in which the issue was encountered.The failure to detach issue was not confirmed based on the functional evaluation performed.The returned pulserider device underwent functional evaluation with the returned concomitant pulserider accessory cable.The implant detached without any issue.Failure to detach, device movement, recapture difficulty, and aneurysm perforation are known potential procedural complications associated with the pulserider anrd.Per the pulserider instructions for use (ifu): when the implant is in position and deployed at the desired location, ensure the microcatheter has been sufficiently retracted to allow the implant to unsheath fully.Verify the implant is fully deployed by confirming that the delivery wire marker is distal to the microcatheter tip marker.Place the coil delivery microcatheter through the pulserider implant and into the sac of the aneurysm.Proceed carefully with coiling the aneurysm.The pulserider implant should remain attached to the delivery wire until a sufficient basket of coils has been placed within the aneurysm to prevent the pulserider implant from being unintentionally advanced into the aneurysmal sac.Use fluoroscopy to confirm that the implant has remained in the desired position and that the delivery wire marker is distal to the microcatheter tip (this ensures that the predetermined delivery wire detachment zone is exposed and ready for detachment).The physician reportedly attempted to detach the anrd without exposing the predetermined delivery wire detachment zone from the concomitant microcatheter.Based on the review of manufacturing documentation, there is no indication that the event is related to the device manufacturing process.Root case of the reported issues remain speculative and inconclusive.The reported issue related to detachment was not confirmed based on the functional evaluation performed on the returned device.The issue related to stability or instability of the device is procedurally dependent on the patient¿s anatomy and clinical factors.Recapturability of the device could not be confirmed as the introducer was returned separated from the 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.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 10/1/2020 and on 10/4/2020.[additional event information]: the healthcare professional reported that during the stent-assisted coil embolization procedure targeting a basilar tip aneurysm, the pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / w3471-05) was deployed and the first coil (unspecified brand) was placed inside the target aneurysm, when the pulserider detachment controller showed an error when the physician attempted to detach the device.The controller was rebooted but the error remained.The controller and accessory cables (prdsacd / 30393939) were replaced but the same issue continued.The physician suspected the possibility of device detachment and attempted to remove the device, but the pulserider device ¿fell down because it was not able to be detached.¿ the physician attempted to resheath the pulserider device, but the coiling catheter was ¿in the inside, so the pulserider strut was as if it sandwiched the microcatheter and became stuck.¿ the physician noticed the situation with the catheter and attempted to unlock the catheter by slightly retracting the pulserider device, but the pulserider device ¿jumped into the aneurysm¿ and bleeding was confirmed on subsequent imaging.Hemostasis was achieved when heparin was reversed.Subsequent verification of the recording revealed that the pulserider was not in the ¿proper exposure state¿ before the physician attempted the detachment, the physician recognized this issue as user error.The procedure will be re-attempted in two weeks.Additional information was received on (b)(6) 2020.The information indicated that at the time of the incident, one coil was inside the aneurysm, and the pulserider device was being manipulated.Neither the coil nor the pulserider device were detached at the time of the reported event, even though there were multiple attempts to detach the pulserider device were made.After the discovery of the rupture, the coil and the pulserider device were both removed.The coil was initially wrapped around one arch of the pulserider device, but the physician was able to free the coil from the device.No products were left inside the patient.It was reported that the patient will be brought back on (b)(6) 2020 for another attempt to implant the coils and the pulserider.Additional information received on (b)(6) 2020.The information indicated that the heparin reversal stopped the bleeding.When the detachment button was pressed, the error appeared and remained on the display.It was reported that when switching on the detachment system power switch, a self-test of all indicators was performed ¿ green and red flashes with both leds.When switched on, the battery indicator remained constantly lit indicating a charged battery.When the start button was pressed, a steady acoustic signal emitted and the steady red indicator displayed signifying unsuccessful cycle initiation.The steady acoustic signal emitted with flashing red indicator display (interrupt cycle, open circuit) when the detachment cycle was initiated.The pulserider accessory cable was reported as an impacted product because the physician wants to confirm that the product was functioning as expected and without anomaly.It was confirmed that there was proper connection between the detachment power supply and the delivery wire or patient¿s groin (return electrode).The concomitant microcatheter functioned as intended.Additional information received on (b)(6) 2020 indicated that the patient was successfully re-treated with a pulserider 8t device on (b)(6) 2020 without any complication.H.6: patient codes: the fda code: no code available fda 3191; c64343 was chosen to capture the surgical procedure delay as the original procedure was stopped; it was successfully re-attempted on (b)(6) 2020.Updated sections: e.1, e.3, g.4, g.7, h.2, h.6, and h.10.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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Search Alerts/Recalls
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