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

Catalog Number	GLX120406
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physical manufacturer: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a health care professional, during a coil embolization to retreat an aneurysm of the middle cerebral artery (mca), ¿a lot¿ of resistance was felt while pushing the last 1cm of a galaxy g3 xsft (glx120406, l10709), causing the headway duo microcatheter (mc) to kick back.The mc did come out of the aneurysm and there was loss of cerebral target position.This was the first coil and was successfully detached.Then the third coil, an orbit galaxy g3 mini (glm915030, s15107) did not detach on the first and second trial.The third coil was placed.There was no report of patient injury or additional intervention required.The procedure was successfully completed.There were no surgical delayed due to the reported event.A galaxy g3 mini coil (glm920040) was also implanted as the second coil with no issues.Pre-deployment electrical check was performed with the unknown type of detachment control box (dcb) and connecting cable.The same dcb and connecting cable was used to detach subsequent coils.Additional information clarified that the headway duo mc was pushed out of the aneurysm by the stiffness of the coil.The coil did not kink or bend at any time prior to the resistance/friction.The same mc was used with subsequent coils.There was no excessive forced used at any time during the procedure.There were no issues with the second coil implanted.(b)(4).The galaxy g3 xsft product was not returned for investigation as it was implanted.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Without the return of the device for analysis, the reported event could not be confirmed.The ifu warns to never advance or withdraw an intraluminal device against resistance.Movement or force of catheter or guide wire against resistance could dislodge a clot, perforate a vessel wall, or severely damage the catheter and/or guide wire.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.
Event or Problem Description
As reported by a health care professional, during a coil embolization to retreat an aneurysm of the middle cerebral artery (mca), ¿a lot¿ of resistance was felt while pushing the last 1cm of a galaxy g3 xsft (glx120406, l10709), causing the headway duo microcatheter (mc) to kick back.The mc did come out of the aneurysm and there was loss of cerebral target position.This was the first coil and was successfully detached.Then the third coil, an orbit galaxy g3 mini (glm915030, s15107) did not detach on the first and second trial.The third coil was placed.There was no report of patient injury or additional intervention required.The procedure was successfully completed.There were no surgical delayed due to the reported event.The devices will not be returned as they were implanted.A galaxy g3 mini coil (glm920040) was also implanted as the second coil with no issues.Pre-deployment electrical check was performed with the unknown type of detachment control box (dcb) and connecting cable.The same dcb and connecting cable was used to detach subsequent coils.Additional information clarified that the headway duo mc was pushed out of the aneurysm by the stiffness of the coil.The coil did not kink or bend at any time prior to the resistance/friction.The same mc was used with subsequent coils.There was no excessive forced used at any time during the procedure.There were no issues with the second coil implanted.

• 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: 7307557
• Report Number: 3008114965-2018-00549
• Device Sequence Number: 11077929
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 10/31/2020
• Device Catalogue Number: GLX120406
• Device Lot Number: L10709
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1