MAUDE Adverse Event Report: CERENOVUS, INC. GALAXY G3 MINI 2MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLM920040

Device Problems Stretched (1601); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section b3 ¿ date of event: the date of the event was not reported.Section d4- expiration date not available at time of reporting.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Section h4- device manufactured date not available at time of reporting.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

Event Description

As reported by the field, during a coil embolization, after a galaxy g3 mini 2mm x 4cm coil (glm920040, 30836570) entered the headway microcatheter (mc), it cannot be delivered.It is suspected that it is rolled up in the catheter.Because it cannot be pushed forward, the coil stretches.Because it is stuck in the micro catheter, it cannot enter or exit, so the product cannot be retrieved.Additional information received indicated that the galaxy g3 mini was ¿stuck¿ in the mc.The resistance was felt at the near the distal tip.The coil was removed with the mc.No additional intervention was needed to remove the device form the patient.The microcatheter did not kink.An adequate flush was maintained through the devices.There was about a 20 minute procedural delay due to the event.The delay was not clinically significant.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, b3, g3, g6, h2 and h10.Section b3.Date of event: 6/26/2023 a supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a coil embolization, after a galaxy g3 mini 2mm x 4cm coil (glm920040, 30836570) entered the headway microcatheter (mc), it cannot be delivered.It is suspected that it is rolled up in the catheter.Because it cannot be pushed forward, the coil stretches.Because it is stuck in the micro catheter, it cannot enter or exit, so the product cannot be retrieved.Additional information received indicated that the galaxy g3 mini was ¿stuck¿ in the mc.The resistance was felt at the near the distal tip.The coil was removed with the mc.No additional intervention was needed to remove the device form the patient.The microcatheter did not kink.An adequate flush was maintained through the devices.There was about a 20-minute procedural delay due to the event.The delay was not clinically significant.One video was attached, and the review was made by an independent physician and the results are shown below: ¿the full situation is not totally clear from the video, but it seems like there is a limited forward and backward movement of the coil with coil stretching.It cannot be assessed from the video provided whether this is due to narrowing in the microcatheter, or outside icad indenting on the catheter, or failure of the device.Analysis of the coil and catheter, if available, may lead to a better understanding of the occurrence¿.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.A manufacturing record evaluation was performed for the finished device 30830570 number, and no non-conformances related to the malfunction were identified.This investigation was performed based only on the video provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: GALAXY G3 MINI 2MM X 4CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17316787
• MDR Text Key: 319890763
• Report Number: 3008114965-2023-00506
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080305
• UDI-Public: 10886704080305
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K171862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2023

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
• Device Operator: Health Professional
• Device Model Number: GLM920040
• Device Catalogue Number: GLM920040
• Device Lot Number: 30830570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/24/2023; 08/11/2023
• Supplement Dates FDA Received: 07/24/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEADWAY MICROCATHETER.