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	Separation Failure (2547); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
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, ethnicity, and medical history were not provided.Procode: krd/hcg.The name, phone and email address of the initial reporter are not available / reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).[conclusion]: the healthcare professional reported that during the coil embolization of an aneurysm at the internal carotid-posterior communicating artery (icpc) with subarachnoid hemorrhage (sah), the 2.5mm x 4.5cm galaxy g3 mini coil (glm925045 / l14416) was used; there was no issue during the pre-deployment electrical check.However, there was strong resistance when it was delivered to the target lesion, due to the detachment marker on the delivery wire being too stiff.The coil was inserted with some difficulty, and the detachment cycle was initiated.The green light did not illuminate, and the coil did not detach.The coil was replaced with another coil.The procedure was completed with a competitor product.There was no report of any patient adverse event or complication.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the 2.5mm x 4.5cm galaxy g3 mini coil was received contained in a pouch.Visual inspection was performed.The introducer was observed kinked and partially zipped.The marker band was found at 39cm from the distal end.This is within specification.Microscopic inspection was performed.The embolic coil was found outside of the introducer and in kinked condition.No other damages were observed.Functional analysis: the resistance of the device was measured with multimeter and a lab sample enpower control cable.The resistance was measured to be 50.2 o, which is in of the specification range between 48.5 o ¿ 56.0 o the 2.5mm x 4.5cm galaxy g3 mini coil was connected to detachment control box (dcb) with a lab sample enpower control cable and the power was turned on.The system ready light was illuminating.A detachment cycle was initiated when the detach button was pressed.The embolic coil was detached from the device.A review of manufacturing documentation associated with this lot (l14416) 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.The reported issue related to resistance and difficulty when the coil was delivered to the target lesion could not be confirmed through functional analysis as the coil introducer was kinked and the embolic coil was also in kinked condition.The returned device underwent evaluation for the reported detachment issue; the failure to detach issue was not confirmed through functional evaluation.The returned device has its resistance measured and was connected to the lab sample enpower control cable and detachment control box, the detachment cycle was initiated, and the coil detached without issue.Coil kinking is a known potential issue associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as kink from occurring.The coil kinked condition was not originally reported with the complaint.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the observed kinked embolic coil on the returned device could not be conclusively determined, however, it is possible that force was inadvertently applied when the issue related to the strong resistance encountered when the coil was delivered to the target lesion due to the detachment marker on the delivery wire being too stiff.The coil was reportedly inserted with some difficulty.The kinked condition of the coil could have been the result of the difficulty issue encountered during the coil insertion.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 2.5mm x 4.5cm galaxy g3 mini coil left the manufacturing facility with the embolic coil in a kinked condition as observed on the returned device.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 of an aneurysm at the internal carotid-posterior communicating artery (icpc) with subarachnoid hemorrhage (sah), the 2.5mm x 4.5cm galaxy g3 mini coil (glm925045 / l14416) was used; there was no issue during the pre-deployment electrical check.However, there was strong resistance when it was delivered to the target lesion, due to the detachment marker on the delivery wire being too stiff.The coil was inserted with some difficulty, and the detachment cycle was initiated.The green light did not illuminate, and the coil did not detach.The coil was replaced with another coil.The procedure was completed with a competitor product.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr is to include the additional event information received on 1/21/2020.E.1: the initial reporter phone: (b)(6).Updated sections: (b)(6).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
• MDR Report Key: 9498157
• Report Number: 3008114965-2019-01293
• Device Sequence Number: 10827685
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 11/30/2021
• Device Model Number: GLM925045
• Device Catalogue Number: GLM925045
• Device Lot Number: L14416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1