MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM930060
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
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.Initial reporter phone: (b)(6).The initial reporter email address is 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 procedure, the 3.00mm x 6.00cm galaxy g3 mini coil (glm930060 / l14479) was used but the coil was not able to exit from the introducer sheath.The coil was replaced.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3.00mm x 6.00cm galaxy g3 mini coil was returned and received contained inside a pouch.Visual inspection was performed.The resheathing tool was observed broken in two.The device underwent microscopic inspection.The embolic coil was inside the introducer tube; it had been mechanically separated from the delivery system and the coil was in stretched and kinked condition.No other damages were observed on the returned complaint device.A review of manufacturing documentation associated with this lot (l14479) 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 complaint reported that the coil could not exit from the introducer sheath.The issue was confirmed with the microscopic inspection of the returned device; the embolic coil was mechanically detached and observed to be in stretched and kinked condition.The condition of the coil (detached, kinked and stretched) would prevent it from being able to exit the introducer sheath.The likely cause of the reported issue is applied force.It is possible that during procedural handling of the complaint device, undue force was inadvertently applied which resulted in the coil becoming mechanically separated from the delivery system; the stretched and kinked condition could have been the result of the attempt to get the coil to exit the introducer sheath.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 3.00mm x 6.00cm galaxy g3 mini coil left the manufacturing facility with the damages observed on the embolic coil during the microscopic inspection.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 procedure, the 3.00mm x 6.00cm galaxy g3 mini coil (glm930060 / l14479) was used but the coil was not able to exit from the introducer sheath.The coil was replaced.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation.During the visual / microscopic inspection of the returned device, the embolic coil was observed mechanically detached in stretched and kinked condition inside the introducer tube.Based on the product analysis 2/24/2020, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: GALAXY G3 MINI 3MM X 6CM
• 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: 9753702
• Report Number: 3008114965-2020-00040
• Device Sequence Number: 13999616
• Product Code: KRD
• UDI-Device Identifier: 10886704080336
• UDI-Public: 10886704080336
• 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
• Report Date (Section B): 02/04/2020

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: GLM930060
• Device Catalogue Number: GLM930060
• Device Lot Number: L14479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1