|
|
| Model Number GLM910020 |
| Device Problems
Break (1069); Failure to Advance (2524)
|
| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 06/07/2023 |
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.Based on the pre-shipment pictures received for the galaxy g3 mini 1mm x 2cm, it was noted that the core wire has three kinked conditions.The kinked conditions noted in the core wire are not originally reported in the complaint.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - 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.Pre-shipment pictures were attached to the complaint file in which it was noted that the core wire has three kinked conditions; two of them were noted in the proximal section.The coil was noted partially inside of the introducer, and it was noted that it is folded.It was not able to determine if, in the folded section, the coil had some damage (i.E., kinked or stretched).The coil remains attached to the resistance heating (rh).No other damages or abnormalities were able to be seen in the pictures.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.The issue regarding a coil being impeded was confirmed based on the folded condition noted in the coil; this condition may be the result of the impeding condition experienced during the coil advancement, where the device was retracted and then moved forward.However, the issue regarding an introducer being damaged was not able to be confirmed since no damage was observed in the introducer.The kinked conditions noted in the core wire are not originally reported in the complaint, and they may have appeared during the insertion of the device into the hoop dispenser.This investigation was performed based only on the photos provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00398.
|
| |
|
Event Description
|
|
As reported by the field, this was a coil embolization of ruptured right middle cerebral artery aneurysm, subarachnoid hemorrhage (sah) case.An 8fr launcher, guidepost and phenom17 were delivered, and the coil embolization was initiated.After a 3mm x 6cm galaxy xsft was implanted as a first coil, a galaxy g3 mini 1mm x 2cm coil (glm910020, 30704815) was used as a second coil, and became stuck inside the microcatheter, which could not be delivered even pushing.The sheath was damaged because the coil was pushed too hard.Then the user opened a new galaxy g3 mini 1mm x 2cm coil (glm910020, 30838866) which became stuck as well and unraveled or early detached inside the microcatheter during retrieval.The microcatheter was then pulled out and replaced with another new phenom17.The embolization was completed with using the new phenom17 and a new galaxy g3 mini 1mm x 3cm.(the new galaxy g3 mini_1x2 was not available, so 1x3 was used).There was no negative impact to the patient.A continuous flush was done.Other concomitant devices are phenom microcatheter, guidepost catheter, 8frlauncher.Based on the pre-shipment pictures received for the galaxy g3 mini 1mm x 2cm, it was noted that the core wire has three kinked conditions.The kinked conditions noted in the core wire are not originally reported in the complaint.
|
| |
|
Manufacturer Narrative
|
|
Product complaint # (b)(4).Complaint conclusion: as reported by the field, this was a coil embolization of ruptured right middle cerebral artery aneurysm, subarachnoid hemorrhage (sah) case.An 8fr launcher, guidepost and phenom17 were delivered, and the coil embolization was initiated.After a 3mm x 6cm galaxy xsft was implanted as a first coil, a galaxy g3 mini 1mm x 2cm coil (glm910020, 30704815) was used as a second coil, and became stuck inside the microcatheter, which could not be delivered even pushing.The sheath was damaged because the coil was pushed too hard.Then the user opened a new galaxy g3 mini 1mm x 2cm coil (glm910020, 30838866) which became stuck as well and unraveled or early detached inside the microcatheter during retrieval.The microcatheter was then pulled out and replaced with another new phenom17.The embolization was completed with using the new phenom17 and a new galaxy g3 mini 1mm x 3cm.(the new galaxy g3 mini_1x2 was not available, so 1x3 was used).There was no negative impact to the patient.A continuous flush was done.Other concomitant devices are phenom microcatheter, guidepost catheter, 8frlauncher.Additional information received confirmed that the devices could not be advanced.There was no evidence of physical material within the devices.A 3x6 galaxy g3 was implanted successfully prior to the encountered resistance.Excessive force was applied to the device.There were no procedural delays due to the event.Additional information was received on 10-aug-2023 indicating that no torque was applied.No torqueing device was used.The resistance was felt at the microcatheter¿s shaft proximal about one-third.The event was prolonged for about 20 minutes.There was no report of the delay being clinically significant.No calcification or stenosis.Normal tortuosity.The aneurysm was 2.5×3.5mm sah on rt/mca bifurcation.Pre-shipment pictures were attached to the complaint file in which it was noted that the device was inside the dispenser hoop.The core wire has three kinked conditions; two of them were noted in the proximal section.The coil was noted partially inside of the introducer, and it was noted that it is folded.It was not able to determine if, in the folded section, the coil had some damage (i.E., kinked or stretched).The coil remains attached to the resistance heating (rh).No other damages or abnormalities were able to be seen in the pictures.A non-sterile galaxy g3 mini 1mm x 2cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the device was not returned inside the dispenser hoop.Two (2) kinked conditions were found on the core wire; the first right next to the connector, and the second at 121.5 cm from the proximal end of the device.Two (2) slits were observed on the introducer sheath causing the core wire to protrude.The embolic coil was found still inside the introducer sheath.Microscopic inspection was performed on the embolic coil and the tip of the embolic coil was noted outside the introducer sheath.Three (3) kinked conditions were noted on the embolic coil, and it was noted to still be attached to the resistance heating (rh) coil.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the embolic coil being impeded in the microcatheter could not be evaluated due to the damaged conditions of the embolic coil inside the introducer sheath; however, this damaged may had been the result of the impeded condition experienced during the coil advancement, where the device was retracted and then moved forward.According to the risk documentation, a damaged coil is a potential failure mode that can occur during the coil placement into the microcatheter and position in aneurysm.Due to this, the impeded condition of the embolic coil and damages on the introducer sheath were confirmed.Normal tortuosity was reported; however, with the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.The kinked conditions noted in the core wire are not originally reported in the complaint, and they may have appeared during the insertion of the device into the hoop dispenser.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following indication: ¿ if unusual friction is noted 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 back-flow of blood.Visually inspect the alignment of the introducer tip and the microcatheter hub to ensure they have not slipped apart.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
|
| |
|
Manufacturer Narrative
|
|
Product complaint # (b)(4).Section b5: additional information was received on 10-aug-2023 indicating that no torque was applied.No "torquing" device was used.The resistance was felt at the microcatheter¿s shaft proximal about one-third.The event was prolonged for about 20 minutes.There was no report of the delay being clinically significant.No calcification or stenosis.Normal tortuosity.The aneurysm was 2.5×3.5mm sah on rt/mca bifurcation.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.
|
| |
|
Search Alerts/Recalls
|
|
|
