MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 3.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX122535
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00037.Additional procode krd.(b)(4).The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
As reported by a healthcare professional, during the procedure it was discovered that a galaxy g3 xsft coil was stretched.The coil was partially deployed into an aneurysm through a competitor¿s aneurysm.The coil was removed and upon removal the coil appeared to have stretched.The coil was successfully removed and the procedure was completed.There were no serious injuries to the patient.There were no medical interventions or surgical delays due to the reported event.The catheter and the complaint is available for investigation.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00037.As reported by a healthcare professional, during the procedure it was discovered that a galaxy g3 xsft coil was stretched.The coil was partially deployed into an aneurysm through a competitor¿s aneurysm.The coil was removed and upon removal the coil appeared to have stretched.The coil was successfully removed and the procedure was completed.There were no serious injuries to the patient.There were no medical interventions or surgical delays due to the reported event.The catheter and the complaint is available for investigation.Update 21feb2017: the procedure was coil embolization of an aneurysm at the internal carotid artery.The physician was having difficulties deploying the complaint coil in the aneurysm and could not get the entire coil into the aneurysm.It was reported that the microcatheter was not repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the catheter.It was suspected that coil entanglement with previously placed coils may have contributed to the event.There were no kinks or bends on the microcatheter.The coil was removed from the patient and was still attached to the delivery system.The procedure was completed successfully.An adequate continuous flush was maintained through the microcatheter at all times.There was no resistance when the coil was advanced, repositioned or withdrawn through the microcatheter.Limited information was received.The sl-10 microcatheter was returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.Unreported damage of the stretched coil severing was found.Unreported damage of the introducer sheath being completely removed from the device positioning unit (dpu and coil was found.The coil was partly unraveled out of the soldered section.The coil was found to have been severed with the distal section not returned.The fracture is ductile in nature requiring external force.No material defects were found.The distal severed section was not found inside the microcatheter.The microcatheter was returned undamaged with the inner lumen in good condition.No manufacturing defects were found.The circumstances of how and when all the above unreported damage occurred cannot be determined.The complaint of the coil deployment difficulty and stretching is confirmed.Due to unreported coil severing, the introducer sheath was found completely separated from the dpu, and that the sl-10 microcatheter was found to be a non-contributing factor, therefore the exact root cause of the coil¿s deployment difficulty and stretching cannot be determined, however the evidence as received highly suggests that the most likely contributing factor to the coil stretching and deployment difficulty appears to have occurred advancement of the coil inside the target site.The coil may have been temporarily anchored on the coils already dwelling inside the aneurysm (if previously placed), on itself, or on the distal tip of the microcatheter.Per complaint, ¿¿it was suspected that coil entanglement with previously placed coils may have contributed to the event¿¿ if this was a factor, then for optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿¿caution: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.Caution: if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter¿¿ concerning the coil severing, one possible contributing factor may have occurred post-procedurally when the dpu and coil were separated from the introducer sheath as it was stated the coil was still attached to the dpu.Complaint history has shown that the coil can be stretched and severed when pulled through the sheath¿s skive and separated from the introducer sheath as was found.In addition, without the return of the distal section of the coil used in the procedure, it cannot be determined if this component had any additional contributions to the complaint event.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information and the analysis, the event was confirmed.The root cause of the reported failure could not be determined however procedural factors during advancement of the coil inside the target site likely contributed to the event.It was determined that the returned sl-10 microcatheter was non-contributing factor to the event; without return of distal section of the coil it cannot be determined if the component had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.Device codes corrected.

• Brand Name: GALAXY G3 XSFT 2.5MM X 3.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6347394
• Report Number: 2954740-2017-00037
• Device Sequence Number: 916673
• Product Code: HCG
• UDI-Device Identifier: 10886704077619
• UDI-Public: (01)10886704077619(17)190630(10)S11284
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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: 06/30/2019
• Device Catalogue Number: GLX122535
• Device Lot Number: S11284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 02/28/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHTER