MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120406
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
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.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).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (l13784) 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 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 procedure targeting an aneurysm at the internal carotid-posterior communicating artery junction (ic-pc), the 4mm x 6cm galaxy g3 xsft coil (glx120406 / l13784) was used as the tenth coil, but the green system ready light did not illuminate and the coil did not detach.The physician attempted several times, but the same issue continued.Prior to this coil, another 4mm x 6cm galaxy g3 xsft coil from the same lot was used as the ninth coil and it was implanted without any issue.The complaint coil was replaced with another coil, a 4mm x 8cm galaxy g3 xsft coil (glx120408) and this replacement coil detached and was implanted in the target aneurysm without any issue.The procedure was completed with twelve coils successfully implanted.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 submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure targeting an aneurysm at the internal carotid-posterior communicating artery junction (ic-pc), the 4mm x 6cm galaxy g3 xsft coil (glx120406 / l13784) was used as the tenth coil, but the green system ready light did not illuminate and the coil did not detach.It was reported that a pre-deployment electrical check was performed; all the connections fit properly without application of force.The physician attempted several times, but the same issue continued.Prior to this coil, another 4mm x 6cm galaxy g3 xsft coil from the same lot was used as the ninth coil and it was implanted without any issue.The complaint coil was successfully removed from the patient and was replaced with another coil, a 4mm x 8cm galaxy g3 xsft coil (glx120408) and this replacement coil detached and was implanted in the target aneurysm without any issue.The procedure was completed without procedural delay with twelve coils successfully implanted.There was no report of any patient adverse event or complication.The device was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4mm x 6cm galaxy g3 xsft coil was received contained in a pouch.Visual inspection was performed.The core wire was observed exposed and kinked.The marker band was observed at 41 cm from the distal end; this is within the specification.The returned device underwent microscopic inspection.The resistance heating (rh) coil did not show evidence it was heated; the embolic coil was observed still attached to the rh in good condition.There was no other damage observed.Functional test: the resistance of the returned device was measured with a multimeter.The readings were unstable.The device was then connected to a detachment control box (dcb) with a lab sample enpower control cable.The power was turned on.The system ready light did not illuminate.A review of manufacturing documentation associated with this lot: (l13784) 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 documented that the 4mm x 6cm galaxy g3 xsft coil was the 10th coil chosen to be used for the procedure, however, the green system ready light did not illuminate, and the coil did not detach was confirmed.The kinked and exposed core wire may have been a contributing factor to the reported issue, though this is not conclusively determined.The kinked condition of the core wire is likely due to force.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6) 2020.E.1: initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that during the coil embolization procedure targeting an aneurysm at the internal carotid-posterior communicating artery junction (ic-pc), the 4mm x 6cm galaxy g3 xsft coil (glx120406 / l13784) was used as the tenth coil, but the green system ready light did not illuminate and the coil did not detach.It was reported that a pre-deployment electrical check was performed; all the connections fit properly without application of force.The physician attempted several times, but the same issue continued.Prior to this coil, another 4mm x 6cm galaxy g3 xsft coil from the same lot was used as the ninth coil and it was implanted without any issue.The complaint coil was successfully removed from the patient and was replaced with another coil, a 4mm x 8cm galaxy g3 xsft coil (glx120408) and this replacement coil detached and was implanted in the target aneurysm without any issue.The procedure was completed without procedural delay with twelve coils successfully implanted.There was no report of any patient adverse event or complication.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 3/25/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 XSFT 4MM 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: 9842540
• Report Number: 3008114965-2020-00043
• Device Sequence Number: 13644300
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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,Followup,Followup
• Report Date (Section B): 02/24/2020

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: 09/30/2021
• Device Model Number: GLX120406
• Device Catalogue Number: GLX120406
• Device Lot Number: L13784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 03/26/2020; 03/27/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 03/25/2020; 03/26/2020; 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1