MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120410
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
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 (b)(4).The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.The healthcare professional reported that during a coil embolization of a superior mesenteric artery aneurysm and middle colic artery aneurysm, an approach was made with the catheter toward the middle colic artery aneurysm.The embolization was performed by packing and returning branches.The first and second branches were embolized with target xl coils (stryker).The 4mm x 10cm galaxy g3 xsft coil (glx120410 / 30419315) was used as the third coil.The coil was taken out.When the coil was used by pressing against the hub of the excelsior® sl-10® microcatheter (stryker) and rewound several times, the complaint coil unraveled.The complaint coil was removed with the microcatheter; the microcatheter gained access to the embolization point and imaging revealed that the flow had stopped.The procedure was completed.It was reported that continuous flush was maintained.There was no problem with the patient.On (b)(6)2022, additional information was received.The information indicated that there was no resistance was reported between the guidewire and the microcatheter when the target site was being accessed.The reported issue occurred during the repositioning in the aneurysm (withdrawal / re-withdrawal).The microcatheter was not repositioned over the coil while the coil was deployed out of the distal end of the microcatheter; the coil was not used like a guidewire to reposition the microcatheter.There was no additional damage noted on the complaint coil aside from the reported unraveled condition when it was removed.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30419315) 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 stretching / unraveling is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Coil stretching / unraveling can occur during attempts to withdrawal the coil against resistance.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot 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 sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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 of a superior mesenteric artery aneurysm and middle colic artery aneurysm, an approach was made with the catheter toward the middle colic artery aneurysm.The embolization was performed by packing and returning branches.The first and second branches were embolized with target xl coils (stryker).The 4mm x 10cm galaxy g3 xsft coil (glx120410 / 30419315) was used as the third coil.The coil was taken out.When the coil was used by pressing against the hub of the excelsior® sl-10® microcatheter (stryker) and rewound several times, the complaint coil unraveled.The complaint coil was removed with the microcatheter; the microcatheter gained access to the embolization point and imaging revealed that the flow had stopped.The procedure was completed.It was reported that continuous flush was maintained.There was no problem with the patient.On (b)(6) 2022, additional information was received.The information indicated that there was no resistance was reported between the guidewire and the microcatheter when the target site was being accessed.The reported issue occurred during the repositioning in the aneurysm (withdrawal / re-withdrawal).The microcatheter was not repositioned over the coil while the coil was deployed out of the distal end of the microcatheter; the coil was not used like a guidewire to reposition the microcatheter.There was no additional damage noted on the complaint coil aside from the reported unraveled condition when it was removed.

• Brand Name: GALAXY G3 XSFT 4MM X 10CM
• 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: 15004393
• Report Number: 3008114965-2022-00468
• Device Sequence Number: 1880312
• Product Code: KRD
• UDI-Device Identifier: 10886704077718
• UDI-Public: 10886704077718
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: 07/31/2023
• Device Model Number: GLX120410
• Device Catalogue Number: GLX120410
• Device Lot Number: 30419315
• 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: 06/28/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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: 4 FR COBRA GUIDING CATHETER (MERIT MEDICAL); ENPOWER DCB 2; EXCELSIOR® SL-10® MICROCATHETER (STRYKER); TARGET XL COILS (STRYKER)
• Patient Sex: Unknown