| Model Number GLY120925 |
| Device Problems
Entrapment of Device (1212); Stretched (1601); Positioning Problem (3009)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/20/2022 |
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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, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an unruptured basilar artery tip aneurysm via the trans-cell technique, an 8fr slim guide® (medikit co, ltd) was introduced into the left subclavian artery, and a sofia¿ 6f intermediate catheter (microvention) was introduced from the left vertebral artery (va) to the proximal basilar artery (ba).The headway® duo microcatheter (microvention) was placed near the left va union, and the headway® 27 microcatheter (microvention) was placed under the aneurysm neck.After the introduction of the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3069219303) via the headway® 27 microcatheter and externally expanding the bilateral posterior cerebral artery (pca), the headway® 27 microcatheter made an approach into the aneurysm via trans-cell technique.The complaint coil, a 9mm x 25cm galaxy g3 (gly120925 / 30715068) was introduced via the headway® duo microcatheter as the first coil.When the coil was inserted to the detachment marker, imaging was performed for confirmation.There was a gap in the aneurysm wall, and the physician attempted to resheath the coil once, but the coil had unraveled.It was reported that there was no resistance at all and the coil had already been pulled before the front, therefore the device positioning unit (dpu) had already been removed from the patient¿s body.The physician commented that, ¿i was well aware of the possibility that the coil got entangle with the pulserider, so i collected the coil carefully, but i did not recognize the unraveled happened immediately because there was no resistance during collection at all.¿ there was no device malfunction associated with the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd).The complaint documented that the distal access catheter (dac), the microcatheter, and the pulserider were all replaced and the procedure was continued.The replacement pulserider was expanded and coil insertions were performed.The following twenty-six (26) cerenovus coils were implanted: galaxy g3 8mm x 24cm, galaxy g3 8mm x 24cm, galaxy g3 6mm x 15cm, galaxy g3 6mm x 15cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1mm x 3cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1mm x 3cm, and galaxy g3 mini 1mm x 3cm.The pulserider was detached and the procedure was completed.There was no patient adverse event or patient complication reported.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30715068) 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.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.Unraveling/stretching and positioning difficulty are mentioned in the instructions for use (ifu).Coil positioning difficulty due to poor conformability could result in compartmentalization and incomplete packing of the aneurysm.This poses a risk of a bleed and/or the need for additional intervention at a later date.Unraveling or stretching during use could cause premature detachment, separation, protrusion, or herniation into the parent vessel, which could result in non-target site embolization, ischemia, or infarct.Also, if the operator wanted to reposition or remove the coil and the coil became entangled with other coils that were previously placed, it could stretch or displace the previously placed coils if removed.Based on the information provided, these events meet mdr reportability criteria.With the limited information available and without the product available for analysis, the reported issue documented in the complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device 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 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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00479.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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Event Description
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The healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an unruptured basilar artery tip aneurysm via the trans-cell technique, an 8fr slim guide® (medikit co, ltd) was introduced into the left subclavian artery, and a sofia¿ 6f intermediate catheter (microvention) was introduced from the left vertebral artery (va) to the proximal basilar artery (ba).The headway® duo microcatheter (microvention) was placed near the left va union, and the headway® 27 microcatheter (microvention) was placed under the aneurysm neck.After the introduction of the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d/3069219303) via the headway® 27 microcatheter and externally expanding the bilateral posterior cerebral artery (pca), the headway® 27 microcatheter made an approach into the aneurysm via trans-cell technique.The complaint coil, a 9mm x 25cm galaxy g3 (gly120925/30715068) was introduced via the headway® duo microcatheter as the first coil.When the coil was inserted to the detachment marker, imaging was performed for confirmation.There was a gap in the aneurysm wall, and the physician attempted to resheath the coil once, but the coil had unraveled.It was reported that there was no resistance at all and the coil had already been pulled before the front, therefore the device positioning unit (dpu) had already been removed from the patient¿s body.The physician commented that, ¿i was well aware of the possibility that the coil got entangle with the pulserider, so i collected the coil carefully, but i did not recognize the unraveled happened immediately because there was no resistance during collection at all.¿ there was no device malfunction associated with the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd).The complaint documented that the distal access catheter (dac), the microcatheter, and the pulserider were all replaced and the procedure was continued.The replacement pulserider was expanded and coil insertions were performed.The following twenty-six (26) cerenovus coils were implanted: galaxy g3 8mm x 24cm, galaxy g3 8mm x 24cm, galaxy g3 6mm x 15cm, galaxy g3 6mm x 15cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1mm x 3cm, galaxy g3 mini 1mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 2mm x 6cm, galaxy g3 mini 1.5mm x 4cm, galaxy g3 mini 1mm x 3cm, and galaxy g3 mini 1mm x 3cm.The pulserider was detached and the procedure was completed.There was no patient adverse event or patient complication reported.
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Manufacturer Narrative
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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 11-jul-2022.Additional information: on 11-jul-2022, additional information was received.The information indicated that there was no resistance between the guidewire and the microcatheter when accessing the target site.No other damages were noticed on the complaint coil other than the reported unraveled condition.There was no report that the procedure was prolonged.E.1: initial reporter phone: (b)(6).This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00472 and 3008114965-2022-00479.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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