MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2.5MM X 4.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM925045
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization with the target aneurysm at the basilar artery, when the complaint coil a 2.50mm x 4.50cm galaxy g3 mini (glm925045 / l15548) was being inserted into the concomitant sl-10® microcatheter (stryker), there was a little resistance felt between the coil and the microcatheter.The physician proceeded as he/she was thinking it would be fine.However, the complaint coil came out of the peel away / introducer sheath.The delivery wire was pulled back in attempt to restore the introducer sheath, but it was not successful and the complaint coil unraveled.The complaint coil became unstable and was removed.A new coil was implanted and the procedure was successfully complete without any patient adverse event or complication.
Additional Manufacturer Narrative
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 coil embolization with the target aneurysm at the basilar artery, when the complaint coil a 2.50mm x 4.50cm galaxy g3 mini (glm925045 / l15548) was being inserted into the concomitant sl-10® microcatheter (stryker), there was a little resistance felt between the coil and the microcatheter.The physician proceeded as he/she was thinking it would be fine.However, the complaint coil came out of the peel away / introducer sheath.The delivery wire was pulled back in attempt to restore the introducer sheath, but it was not successful and the complaint coil unraveled.The complaint coil became unstable and was removed.A new coil was implanted and the procedure was successfully complete without any patient adverse event or complication.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l15548) 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.Coil unraveling / stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling for the device to prevent such issue from occurring.The embolic coil can become unraveled or stretched during attempts to withdraw it against resistance.With the information provided but without the complaint coil and the concomitant microcatheter available for analyses, the reported issue could not be confirmed through functional evaluation.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint device.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 11-jan-2022.The healthcare professional reported that during a coil embolization with the target aneurysm at the basilar artery, when the complaint coil a 2.50mm x 4.50cm galaxy g3 mini (glm925045 / l15548) was being inserted into the concomitant sl-10® microcatheter (stryker), there was a little resistance felt between the coil and the microcatheter.The physician proceeded as he/she was thinking it would be fine.However, the complaint coil came out of the peel away / introducer sheath.The delivery wire was pulled back in attempt to restore the introducer sheath, but it was not successful and the complaint coil unraveled.The complaint coil became unstable and was removed.A new coil was implanted and the procedure was successfully complete without any patient adverse event or complication.[additional information]: on 11-jan-2022, additional information was received.The information indicated that the target was an internal carotid-posterior communicating artery (icpc) about 5mm.There was no resistance between the guidewire and the microcatheter when the target was being accessed.The information indicated that prior to the complaint coil, no other coils went through the microcatheter; that there was no resistance felt when the next coil was inserted.The resistance issue reported was encountered when the coil was being inserted through the microcatheter, before exiting the microcatheter.The microcatheter was repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter (the coil was used like a guidewire to reposition the microcatheter).There was a one-to-one relationship between the coil and the delivery wire verified with fluoro piro to repositioning.Coil entanglement with previously placed coil was not suspected as a contributing factor to the reported coil unraveled issue.Additional intervention was not required.Aside from the reported unraveled condition of the coil, no other additional damage was reported.The information indicated that after the coil unraveled, it was removed by applying negatige pressure to the microcatheter; it was removed normally.There was no report of any blood flow restriction / reduction as a result of the reported issue.The reported issue did not result in a clinically significant delay in the procedure.E.1: the initial reporter phone: (b)(6).The initial reporter email address is not available / reported.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.

• Brand Name: GALAXY G3 MINI 2.5MM X 4.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13142894
• Report Number: 3008114965-2021-00740
• Device Sequence Number: 1533801
• Product Code: KRD
• UDI-Device Identifier: 10886704080275
• UDI-Public: 10886704080275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 03/31/2022
• Device Model Number: GLM925045
• Device Catalogue Number: GLM925045
• Device Lot Number: L15548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAUNCHER ¿ GUIDE CATHETER (MEDTRONIC); SL-10® MICROCATHETER (STRYKER); TRAXCESS® GUIDEWIRE (MICROVENTION-TERUMO)
• Patient Sex: Unknown