MAUDE Adverse Event Report: SEE H.10 GALAXY G3 3.5MM X 9CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY123509
Medical Device Problem Codes	Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(4).Concomitant med products: sheath introducer (7f long), guidewire (chikai 10, asahi intecc), guide catheter (fubuki 7fr hard, asahi intecc), microcatheter (sl10, stryker), y-connector (sheen-man), enpower control cable (cerenovus), and detachment control box (dcb2, cerenovus).Initial reporter information such as the name, phone and email address are unknown.[conclusion]: the healthcare professional reported that during the coil embolization procedure of an unruptured aneurysm at the anterior communicating artery (acom), the guide catheter (cerulean, medikit) and the microcatheter (sl10, stryker) were inserted into the target site to make a frame using a galaxy g3 4 x 10 coil, but the size of the coil did not fit and the coil was re-sheathed.The galaxy g3 3.5 mm x 9 cm coil (gly123509 / l11078) was introduced into the microcatheter and the size also did not fit.The physician attempted to resheath the coil but the coil was kinked / knotted and became unraveled.The coil and the microcatheter were removed and the target soft 3 x 8 coil were implanted.The procedure was completed and the aneurysm was filled with coils.There were no further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.Based on complaint information, the galaxy g3 3.5 mm x 9 cm coil was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l11078) 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.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of causes and possible contributing factors could be made.As such the investigation will be closed.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.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure of an unruptured aneurysm at the anterior communicating artery (acom), the guide catheter (cerulean, medikit) and the microcatheter (sl10, stryker) were inserted into the target site to make a frame using a galaxy g3 4 x 10 coil, but the size of the coil did not fit and the coil was re-sheathed.The galaxy g3 3.5 mm x 9 cm coil (gly123509 / l11078) was introduced into the microcatheter and the size also did not fit.The physician attempted to resheath the coil but the coil was kinked / knotted and became unraveled.The coil and the microcatheter were removed and the target soft 3 x 8 coil were implanted.The procedure was completed and the aneurysm was filled with coils.There were no further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.

• Brand Name: GALAXY G3 3.5MM X 9CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7666993
• Report Number: 3008114965-2018-00651
• Device Sequence Number: 13857831
• Product Code: KRD
• UDI-Device Identifier: 10886704077442
• UDI-Public: 10886704077442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: GLY123509
• Device Lot Number: L11078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1