MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 3.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX122535
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
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 initial reporter name and email address are not available / reported.The initial reporter phone: (b)(6).[conclusion]: the healthcare professional reported that during a coil embolization procedure, the 2.5mm x 3.5cm galaxy g3 xsft coil (glx122535 / 30670805) was inserted into the concomitant excelsior® sl-10® microcatheter (stryker), but resistance between the complaint coil and the microcatheter was encountered.It was reported that a continuous flush was not maintained through the microcatheter.The complaint coil was removed and replaced with a competitor coil and the procedure was completed.There was no report of any patient adverse event or complication.On 10-jun-2022, additional information was received.The information indicated that the concomitant microcatheter was not removed when the complaint coil was removed.The complaint device did not appear damage.The device could still be moved when the resistance was encountered.Nothing was noted to be obstructing the microcatheter.The complaint device was returned for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 2.5mm x 3.5cm galaxy g3 xsft coil was received contained in a decontamination pouch.Visual inspection was performed.Part of the embolic coil was observed outside of the introducer and in a visibly stretched condition.No other damages were observed during the visual inspection.Microscopic inspection was performed.Under magnification, the portion of the embolic coil that was noted outside of the introducer was also observed in stretched condition.The embolic coil is still attached to the resistance heating (rh) coil.A functional test could not be performed due to the condition in which the device was returned, however, the stretched condition noted on the embolic coil could be the result of the resistance/friction encountered during the procedure.It is possible that the embolic coil was stretched when it was being removed, since according to the information provided, the microcatheter was not removed from the patient and only the embolic coil was removed from the microcatheter.A review of manufacturing documentation associated with this lot (30670805) 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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Coil stretching is known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue as stretching from occurring.The coil stretched condition was not originally reported in the complaint.Stretching can occur during procedure handling where force may have been inadvertently applied.The complaint documented that continuous flush was not maintained, the most likely cause is that inadequate flush might have caused resistance / friction during the removal of the coil, which resulted in the coil stretching.With the limited information available, an assignment of a root cause is not possible, however, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 2.5mm x 3.5cm galaxy g3 xsft coil left the manufacturing facility with the embolic coil in stretched condition as noted during the visual and microscopic inspections.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.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.
Event or Problem Description
The healthcare professional reported that during a coil embolization procedure, the 2.5mm x 3.5cm galaxy g3 xsft coil (glx122535 / 30670805) was inserted into the concomitant excelsior® sl-10® microcatheter (stryker), but resistance between the complaint coil and the microcatheter was encountered.It was reported that a continuous flush was not maintained through the microcatheter.The complaint coil was removed and replaced with a competitor coil and the procedure was completed.There was no report of any patient adverse event or complication.On 10-jun-2022, additional information was received.The information indicated that the concomitant microcatheter was not removed when the complaint coil was removed.The complaint device did not appear damage.The device could still be moved when the resistance was encountered.Nothing was noted to be obstructing the microcatheter.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on 30-jun-2022, the event has been deemed reportable as a "malfunction.".

• Brand Name: GALAXY G3 XSFT 2.5MM X 3.5CM
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14881829
• Report Number: 3008114965-2022-00475
• Device Sequence Number: 5062565
• Product Code: KRD
• UDI-Device Identifier: 10886704077619
• UDI-Public: 10886704077619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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: 09/30/2024
• Device Model Number: GLX122535
• Device Catalogue Number: GLX122535
• Device Lot Number: 30670805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: EXCELSIOR® SL-10® MICROCATHETER (STRYKER)
• Patient Sex: Unknown